Trial Outcomes & Findings for Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br) (NCT NCT00314366)

NCT ID: NCT00314366

Last Updated: 2024-04-23

Results Overview

Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF \[CHF\], acute coronary syndrome, myocardial infarction, stroke, or death).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and 6 months
• Results posted on: 2024-04-23

Participant Flow

Twenty one patients were recruited between 9/1/06 and 8/6/08 from outpatient Cardiology clinics.

Participant milestones

Measure	Stem Cell Therapy Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Overall Study STARTED	11	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Stem Cell Therapy Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Overall Study not treated due to patient medical condi	1	0

Baseline Characteristics

Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)

Baseline characteristics by cohort

Measure	Stem Cell Therapy n=10 Participants Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control n=10 Participants Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Age	58.2 years STANDARD_DEVIATION 6.1 • n=5 Participants	57.8 years STANDARD_DEVIATION 5.5 • n=7 Participants	58.0 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The data was analyzed for all participants in control and treated groups.

Safety of cell injections was assessed by reviewing adverse events at 2 time points: Baseline (periprocedural period up to 2 weeks post-procedure) and at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events Number treated	10 participants	10 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events atrial arrhythmia	0 participants	2 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events EMM realted ventricular tachycardia	2 participants	0 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events EMM related ventricular fibrillation	1 participants	0 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events cerebrovascular event	1 participants	0 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events angina exacerbation	1 participants	5 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events myocardial infarction (NSTEMI)	0 participants	1 participants
Safety of Aldehyde Dehydrogenase Bright Stem Cells Versus the Control Group as Measured by Combined Early and Late Adverse Events intracardiac thrombus	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.

Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
New York Heart Association (NYHA) Classification NYHA baseline	2.5 NYHA Functional class Standard Deviation 0.5	2.6 NYHA Functional class Standard Deviation 0.5
New York Heart Association (NYHA) Classification NYHA 6 months	2.3 NYHA Functional class Standard Deviation 0.5	2.1 NYHA Functional class Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).

Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Canadian Cardiovascular (CCS) Angina Score CCS baseline	2.5 units on a scale Standard Deviation 0.5	2.5 units on a scale Standard Deviation 0.5
Canadian Cardiovascular (CCS) Angina Score CCS 6 months	2.0 units on a scale Standard Deviation 0.0	2.0 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Echocardiography (EF)Percent (%) baseline	36.1 percentage of blood Standard Deviation 10.9	32.1 percentage of blood Standard Deviation 10.6
Echocardiography (EF)Percent (%) 6 months	36.0 percentage of blood Standard Deviation 11.3	34.0 percentage of blood Standard Deviation 9.3

SECONDARY outcome

Timeframe: baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV) when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=9 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Left Ventricular End-Systolic Volume (LVESV) (ml) LVESV baseline	93.2 ml Standard Deviation 46.1	94.9 ml Standard Deviation 59.8
Left Ventricular End-Systolic Volume (LVESV) (ml) LVESV 6 months	85.9 ml Standard Deviation 46.2	94.7 ml Standard Deviation 62.2

SECONDARY outcome

Timeframe: baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Left Ventricular End-Diastolic Volume (LVEDV) LVDEV baseline	138.3 ml Standard Deviation 43.0	132.7 ml Standard Deviation 65.2
Left Ventricular End-Diastolic Volume (LVEDV) LVDED 6 months	127.2 ml Standard Deviation 51.3	131.3 ml Standard Deviation 67.4

SECONDARY outcome

Timeframe: baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI) as defined by the American Heart Association which allows detection of abnormalities in the heart wall or blood flowing through the heart. Using this model, the left ventricle is divided into 17 segments. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Echocardiography Wall Motion Score Index (WMSI) WMSI baseline	1.91 units on a scale Standard Deviation 0.51	2.13 units on a scale Standard Deviation 0.38
Echocardiography Wall Motion Score Index (WMSI) WMSI 6 months	1.90 units on a scale Standard Deviation 0.57	2.06 units on a scale Standard Deviation 0.41

SECONDARY outcome

Timeframe: baseline and 6 months

Population: data from 9 stem cell patients at 6 months, 10 at baseline

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=9 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Myocardial Oxygen Consumption (MVO2) MVO2 baseline	15.5 ml/kg/min Standard Deviation 6.3	14.1 ml/kg/min Standard Deviation 4.8
Myocardial Oxygen Consumption (MVO2) MVO2 6 months	17.7 ml/kg/min Standard Deviation 4.1	14.6 ml/kg/min Standard Deviation 6.7

SECONDARY outcome

Timeframe: baseline and 6 months

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.

Outcome measures

Measure	Control n=8 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=7 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Echocardiography (EF) Percent (%) EF (%) baseline	38.0 percentage of blood Standard Deviation 17.5	41.9 percentage of blood Standard Deviation 11.8
Echocardiography (EF) Percent (%) EF (%) 6 months	40.4 percentage of blood Standard Deviation 15.8	42.2 percentage of blood Standard Deviation 7.6

SECONDARY outcome

Timeframe: baseline and 6 months

For the stress test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling.

Total severity score during stress is the sum of blackout pixels in the blackout polar map of myocardial perfusion during stress using cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.

Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Total Severity Score (Stress) Stress Severity Score (stress) baseline	798.2 units on a scale Standard Deviation 528.7	1007.6 units on a scale Standard Deviation 352.4
Total Severity Score (Stress) Stress Severity Score (stress) 6 months	785.9 units on a scale Standard Deviation 554.6	1132 units on a scale Standard Deviation 588.5

SECONDARY outcome

Timeframe: baseline and 6 months

For the total severity score at rest, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using a clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest.

Total severity score at rest is the sum of blackout pixels in the rest blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by the number of SDs below the mean.

Total severity score varies from 0 (normal) to several thousands although the upper limit is not well defined. A score greater than 1000 indicates poor perfusion.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Total Severity Score (Rest) Total Severity Score (rest) baseline	542.8 units on a scale Standard Deviation 440.7	812.4 units on a scale Standard Deviation 304.5
Total Severity Score (Rest) Total Severity Score (rest) 6 months	594.6 units on a scale Standard Deviation 488.9	828 units on a scale Standard Deviation 396.9

SECONDARY outcome

Timeframe: baseline and 6 months

For the severity test, cardiac SPECT polar mapping (gated dual-isotope) is used to evaluate myocardial cardiac perfusion, compared against a database with a statistically significant number of polar maps of healthy hearts and compared based on gender, data acquisition method, stress vs rest and type of data (i.e. perfusion, wall motion or wall thickening) using clinically validated software package (J Nucl Med Technol 2006; 34:3-17). The basal and mid-ventricle heart wall is mapped by cylindrical sampling and apex mapped by spheric, cylindric and radial sampling at rest/stress.

Total severity score is the sum of blackout pixels in rest/stress blackout polar map of myocardial perfusion cardiac SPECT imaging (adding scores in different views), weighted by number of SDs below mean. Total severity score reversible is total severity scores at rest subtracted from those during stress. The severity score varies from 0 (normal) to > 1000 (poor perfusion) but upper limit is not well defined.

Outcome measures

Measure	Control n=10 Participants Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. At 6 months, subject is offered stem cell therapy and then followed for 12 months. Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.	Stem Cell Therapy n=10 Participants Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Total Severity Score (Reversible) Total Severity Score (reversible) baseline	72.6 units on a scale Standard Deviation 95.2	46.5 units on a scale Standard Deviation 48.5
Total Severity Score (Reversible) Total Severity Score (reversible) 6 months	22.9 units on a scale Standard Deviation 39.2	87.3 units on a scale Standard Deviation 60.2

Adverse Events

Stem Cell Therapy

Serious events: 10 serious events

Other events: 10 other events

Deaths: 0 deaths

Control

Serious events: 10 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stem Cell Therapy n=10 participants at risk Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control n=10 participants at risk Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Cardiac disorders non-ST elevation MI/acute non-ST elevation MI	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders ventricular tachycardia /ventricular tachycardia (ICD shocks)/ ventricular arrhythmia	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders new stenotic lesion in SVG to RCA	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders acute congestive heart failure	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders inappropriate AICD function	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Eye disorders bilateral eye cataracts	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Eye disorders left eye macular edema	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders lightheadness or dizziness	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders cholelithiasis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Injury, poisoning and procedural complications postoperative hematoma	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Injury, poisoning and procedural complications Fentanyl overdose	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Injury, poisoning and procedural complications mild bleeding at right groin cath site	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Nervous system disorders intracerebral hemorrhage/ ischemic stroke/ embolic stroke	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders increased shortness of breath	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders community acquired pneumonia	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Vascular disorders increased claudication	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders dehydration	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders fever of unknown origin	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations hospitalization for sinusitis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders hypotension	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders ideoventricular rhythm	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders ischemic cardiomyopathy	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.

Other adverse events

Measure	Stem Cell Therapy n=10 participants at risk Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter. Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping.	Control n=10 participants at risk Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria. Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml.
Cardiac disorders second degree AV block, type 2	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders acute bronchitis	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders acute renal failure	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Psychiatric disorders altered mental status	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Blood and lymphatic system disorders decreased platelet count	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Blood and lymphatic system disorders anemia	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders irregular heart rhythm	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders left ventricular thrombus	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders hypotension	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	30.0% 3/10 • Number of events 4 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders increased troponin level	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders increased cardiac chest pain	40.0% 4/10 • Number of events 4 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders atrial fibrillation	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders exacerbation of congestive heart failure	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	40.0% 4/10 • Number of events 4 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders heart racing	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders hypertension elevation	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders new onset of atrial fibrillation	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders increased CPK	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders chest pain- nonspecific	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders possible apical thrombus	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders episode of atypical cardiac chest pain	10.0% 1/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders left ventricular apical thrombus	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders sustained ventricular tachycardia	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders diaphoresis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Cardiac disorders short periods of atrial fibrillation	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Ear and labyrinth disorders labyrinthitis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Ear and labyrinth disorders increased hearing loss	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Endocrine disorders elevated blood glucose	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Endocrine disorders low testosterone level	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Eye disorders photophobia	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders stomach flu	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders vomiting	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders diarrhea	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders rectal polyp	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders worsening constipation	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Gastrointestinal disorders epigastric pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders fatigue	30.0% 3/10 • Number of events 4 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	50.0% 5/10 • Number of events 7 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders cold symptoms	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders nasal discharge	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders productive cough	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders fever	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders obstructive sleep apnea	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders headache	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders TIA symptoms	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders cough	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders drowsiness	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders nausea	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders syncope	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders weight loss	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders bleeding from bone marrow site	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders vertigo	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders intermittent right frontal headache	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders dehydration	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders dizziness, lightheadedness	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	40.0% 4/10 • Number of events 4 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders weight gain	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders abnormal sleep pattern	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders nasal congestion	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders athlete's foot	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders lower extremity edema	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders bodyache	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders chills	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders poison oak exposure	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders rash	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders Bells Palsey	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders rash to neck and upper chest	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders rash from Holter	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders nose bleed	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders tooth decay	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders difficulty maintaining sleep	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders forgetfullness	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders mild headache after 6 min walk	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders bruised forehead due to fall	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders minor burns (from Halter electrodes)	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders flu-like syndrome	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders cold feet	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders facial numbness	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
General disorders numbness in extremity	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Hepatobiliary disorders increased liver function tests	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Immune system disorders leukocytosis	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations sinus infection	50.0% 5/10 • Number of events 6 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	30.0% 3/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations strep throat	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations viral syndrome	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations Herpes Simplex	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations influenza	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations tooth infection	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Infections and infestations infection of right index finger	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Injury, poisoning and procedural complications pain at bone marrow harvest site	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Metabolism and nutrition disorders hypoglycemic	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Metabolism and nutrition disorders fluctuating glucose	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Metabolism and nutrition disorders hyponatremia	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Metabolism and nutrition disorders hypokalemia	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Metabolism and nutrition disorders symptomatic volume depletion	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders cervial neck pain	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders bilateral knee pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders pain in left arm	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders left leg cramps	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders left chest pain	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders bone spurs in neck and spine	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders chipped bone fragment in neck	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders bulging disk at lower back	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders injured miniscus	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders bilateral thigh pain	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders soreness in feet	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders left foot fracture	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders sore left arm	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders sore left knee	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders back tightness	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders increase of chronic back pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders shoulder pain	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Musculoskeletal and connective tissue disorders bilateral hyperreflexia	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Psychiatric disorders anxiety	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Psychiatric disorders increased forgetfulness	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Psychiatric disorders psychological stress	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders urinary tract infection	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders elevated blood urea nitrogen (BUN)	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders elevated creatinine level	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders exacerbation of preexisting disease- kidney stones	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders renal insufficiency	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Renal and urinary disorders large right renal cyst	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Reproductive system and breast disorders atrophic vaginitis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders increased shortness of breath	20.0% 2/10 • Number of events 3 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders non-productive cough	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders chest congestion	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Respiratory, thoracic and mediastinal disorders emphysema	10.0% 1/10 • Number of events 1 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.
Vascular disorders plantar fascitis	0.00% 0/10 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.	20.0% 2/10 • Number of events 2 • Adverse event data were collected pre-procedure, during procedure, after procedure, week 1, week 4, month 3 and month 6 post-procedure.

Additional Information

Emerson C. Perin, M.D., Ph.D.

Texas Heart Institute

Phone: 832-355-9405

Email: eperin@texasheart.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place