Trial Outcomes & Findings for Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS) (NCT NCT00587990)

Last Updated: 2019-09-10

Results Overview

Six-month post-CABG surgery serious adverse event (SAE) proportion of patients experiencing a composite of sustained ventricular arrhythmias, (lasting longer than 15 seconds), with hemodynamic compromise, sudden unexpected death at six months, ectopic tissue formation at 12 months by chest/abdomen/pelvis CT exam.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

12 Months

Results posted on

2019-09-10

Participant Flow

This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.

Participant milestones

Participant milestones
Measure	(1) Lower MSC Dose Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.	(2) Higher MSC Dose Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.	(3) Placebo Injection Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
Overall Study STARTED	2	4	3
Overall Study COMPLETED	2	4	2
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	(1) Lower MSC Dose Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.	(2) Higher MSC Dose Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.	(3) Placebo Injection Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
Overall Study Death	0	0	1

Baseline Characteristics

Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	(1) Lower MSC Dose n=2 Participants Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.	(2) Higher MSC Dose n=4 Participants Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.	(3) Placebo n=3 Participants Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).	Total n=9 Participants Total of all reporting groups
Age, Continuous	60.3668720 years STANDARD_DEVIATION 13.4742319 • n=5 Participants	51.9240246 years STANDARD_DEVIATION 9.1760352 • n=7 Participants	63.6276523 years STANDARD_DEVIATION 2.9733072 • n=5 Participants	57.7014222 years STANDARD_DEVIATION 9.3869460 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Number of Patients With Serious Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, 6 Months, 18 Months

Population: One placebo subject expired Day 3 post injection. Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine the low and high dose groups in order to make a comparison to the participants who received a placebo.

Change in infarct scar size (ISS) between baseline and 6-month and 18 month visits as determined by delayed contrast-enhanced MRI.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Infarct Scar Size (ISS) Over 18 Month Period 18 Months	-5.91 Grams (g) Interval -8.85 to -2.97	-5.32 Grams (g) Interval -78.25 to 67.61
Change in Infarct Scar Size (ISS) Over 18 Month Period 6 Months	-2.37 Grams (g) Interval -5.64 to 0.89	-2.16 Grams (g) Interval -40.53 to 36.21

SECONDARY outcome

Timeframe: Assessed at Baseline and 18 Months

The Left Ventricular Function differences in the region of MSC injection were evaluated. LVF is evaluated via ECHO as the percentage of ejected blood.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Left Ventricular Function (LVF) in Region of MSC Injection Baseline	-15.26 percentage of ejected blood Standard Error 3.15	-18.53 percentage of ejected blood Standard Error 2.71
Left Ventricular Function (LVF) in Region of MSC Injection 18 Months	-21.13 percentage of ejected blood Standard Error 1.68	-19.66 percentage of ejected blood Standard Error 1.07

SECONDARY outcome

Timeframe: Assessed at Baseline and 18 months

Difference between baseline and 18 month regional left ventricular wall thickening as determined by MRI.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Regional Left Ventricular Wall Thickening Baseline	20.68 mm Standard Error 6.67	32.21 mm Standard Error 9.97
Regional Left Ventricular Wall Thickening 18 Months	47.87 mm Standard Error 9.45	42.09 mm Standard Error 9.49

SECONDARY outcome

Timeframe: Assessed at Baseline and 18 months

Difference between the baseline and 18 month left ventricular end diastolic wall thickness as determined by MRI and echocardiogram.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Left Ventricular End Diastolic Wall Thickness 18 Months	6.17 mm Standard Error .48	18.54 mm Standard Error 1.55
Left Ventricular End Diastolic Wall Thickness Baseline	5.86 mm Standard Error .46	16.15 mm Standard Error 2.72

SECONDARY outcome

Timeframe: Baseline, 6 Months, 18 Months

Change in left ventricular end diastolic and systolic volume as determined by MRI and echocardiogram.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Left Ventricular End Diastolic and Systolic Volume End Diastolic Volume from Baseline to 6 Months	192.92 ml Interval 115.91 to 281.93	169.63 ml Interval -468.29 to 807.54
Change in Left Ventricular End Diastolic and Systolic Volume End Systolic Volume from Baseline to 6 Months	130.09 ml Interval 46.47 to 213.71	97.13 ml Interval -416.33 to 610.59
Change in Left Ventricular End Diastolic and Systolic Volume End Diastolic from 6 Month to 18 Month	218.73 ml Interval 98.85 to 338.61	172.01 ml Interval -245.46 to 589.47
Change in Left Ventricular End Diastolic and Systolic Volume End Systolic from 6 Month to 18 Month	135.99 ml Interval 29.07 to 242.9	94.90 ml Interval -307.45 to 497.24

SECONDARY outcome

Timeframe: Baseline to 6 Months, Baseline to 18 Months

Change between baseline to 6-month and 18-month left ventricular ejection fraction (LVEF) as determined by MRI and echocardiogram.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Left Ventricular Ejection Fraction Baseline to 6 Months	-.34 percentage of Ejection Fraction Interval -6.6 to 5.92	13.18 percentage of Ejection Fraction Interval -68.65 to 95.01
Change in Left Ventricular Ejection Fraction Baseline to 18 Months	2.50 percentage of Ejection Fraction Interval -3.35 to 8.34	14.61 percentage of Ejection Fraction Interval -59.15 to 88.36

SECONDARY outcome

Timeframe: Baseline, 6 Months, 18 Months

Change in Peak VO2 as determined by treadmill test (mL/mg/min) from Baseline to 6 and from baseline to 18 months

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Peak Volume Oxygen Baseline to 6 Months	.2 (mL/mg/min) Interval -1.1 to 1.4	-.2 (mL/mg/min) Interval -12.9 to 12.5
Change in Peak Volume Oxygen Baseline to 18 Months	-.2 (mL/mg/min) Interval -1.8 to 1.3	-.4 (mL/mg/min) Interval -10.6 to 9.8

SECONDARY outcome

Timeframe: Baseline, 6 Months, 18 Months

Change in Six Minute Walk Test (in meters) from Baseline to 6 Months and Baseline to 18 Months

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Six Minute Walk Test Baseline to 6 Months	67 Meters Interval -453.0 to 309.0	-30.00 Meters Interval -30.0 to -30.0
Change in Six Minute Walk Test Baseline to 18 Months	67 Meters Interval -199.0 to 309.0	-33.0 Meters Interval -36.0 to -30.0

SECONDARY outcome

Timeframe: Baseline to 6 Months, 6 months to 18 Months

Population: Due to the early termination of the study,there was an insufficient sample size of the MSC treated participants.The statistical analysis plan was revised to combine the low and high dose groups.1 treated subject's NYHA class was not captured at the 18 Month time point.1 placebo treated subject expired prior to 6 and 18 months NYHA class assessment.

Change in New York Heart Association (NYHA) Functional Classification based on patient's self reported activity level. Worsened: documented increase in limitations of physical activity as self-described by subject Improved: documented decrease in limitations of physical activity as self-described by subject Unchanged: no documented change in limitations of physical activity as self-described by subject

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Change in NYHA Functional Class 6 Months to 18 Months, Improved	0 Participants	1 Participants
Change in NYHA Functional Class Baseline to 6 Months, Worsened	0 Participants	0 Participants
Change in NYHA Functional Class Baseline to 6 Months, Improved	3 Participants	1 Participants
Change in NYHA Functional Class Baseline to 6 Months, Unchanged	3 Participants	1 Participants
Change in NYHA Functional Class 6 Months to 18 Months, Worsened	2 Participants	0 Participants
Change in NYHA Functional Class 6 Months to 18 Months, Unchanged	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Assessed at 6 Months and 18 Months

Minnesota Living with Heart Failure (MLHF) questionnaire has a total score from 0 to 105. A higher score indicates that participants heart failure is preventing them from living their lives measured at two time points.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Minnesota Living With Heart Failure Questionnaire Scores 6 Month Visit	11.5 score on a scale Interval -10.8 to 33.8	54.5 score on a scale Interval -66.2 to 175.2
Minnesota Living With Heart Failure Questionnaire Scores 18 Month Visit	7.3 score on a scale Interval -3.6 to 18.3	10.5 score on a scale Interval -122.9 to 143.9

SECONDARY outcome

Timeframe: 18 Months

Incidence of Major Adverse Cardiac Events (MACE). A composite incidence of (1) death, (2) hospitalization for heart failure, or (3) non-fatal recurrent Ml.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Incidence of Major Adverse Cardiac Events (MACE)	0 # of Major Adverse Cardiac Events (MACE)	1 # of Major Adverse Cardiac Events (MACE)

SECONDARY outcome

Timeframe: Assessed at 6 Months, 12 Months, and 18 Months

Ambulatory ECG monitoring is the most widely employed technology for the evaluation of a patient with symptoms suggestive of cardiac arrhythmia or conduction abnormality. When the patient returns for follow up the 48- Hour Ambulatory monitor provides the data to the site staff to detect any abnormal recordings based upon standard ECG protocol.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings 6 Month Visit	4 Participants	2 Participants
Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings 12 Month Visit	3 Participants	2 Participants
Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings 18 Month Visit	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 6 Months, 12 Months, 18 Months

Change in Pulmonary Function from Baseline to 6 month, Baseline to 12 month, and Baseline to 18 month visits as measured by forced expiratory volume in 1 second (FEV1)

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Change in Pulmonary Function Baseline to 6 Months	-7.2 Liters Interval -16.3 to 1.9	7.0 Liters Interval -81.9 to 95.9
Change in Pulmonary Function Baseline to 12 Months	-8.5 Liters Interval -18.9 to 1.9	-5.5 Liters Interval -62.7 to 51.7
Change in Pulmonary Function Baseline to 18 Months	-7.2 Liters Interval -23.1 to 8.8	7.5 Liters Interval -176.7 to 191.7

SECONDARY outcome

Timeframe: Assessed at Baseline, 12 hours, 24 hours, 36 hours, and 48 hours post CABG

Serial Troponin Values (ng/mL) Values from Baseline to 48 Hours Post CABG

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Serial Troponin Values (ng/mL) Baseline	.01 ng/mL Interval 0.01 to 0.25	.01 ng/mL Interval 0.0 to 0.01
Serial Troponin Values (ng/mL) 12H	.76 ng/mL Interval 0.03 to 2.0	.76 ng/mL Interval 0.18 to 1.26
Serial Troponin Values (ng/mL) 24H	.35 ng/mL Interval 0.16 to 3.31	.1 ng/mL Interval 0.03 to 0.49
Serial Troponin Values (ng/mL) 36H	.55 ng/mL Interval 0.23 to 2.23	.36 ng/mL Interval 0.13 to 1.57
Serial Troponin Values (ng/mL) 48H	.21 ng/mL Interval 0.14 to 4.44	.2 ng/mL Interval 0.2 to 0.2

SECONDARY outcome

Timeframe: Assessed at Baseline, 12 Hours, 24 Hours, 36 Hours, and 48 hours post CABG

Creatinine Kinase MB (ng/mL) Values every 12 hours from Baseline to 48 Hours Post CABG

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Creatinine Kinase - Muscle/Brain (MB) (ng/mL) Baseline	2.2 ng/mL Interval 0.7 to 8.1	2.6 ng/mL Interval 2.44 to 3.0
Creatinine Kinase - Muscle/Brain (MB) (ng/mL) 12H	19.6 ng/mL Interval 9.0 to 32.1	24.75 ng/mL Interval 16.9 to 30.8
Creatinine Kinase - Muscle/Brain (MB) (ng/mL) 24H	12.39 ng/mL Interval 3.0 to 21.6	15.5 ng/mL Interval 11.5 to 66.28
Creatinine Kinase - Muscle/Brain (MB) (ng/mL) 36H	8.04 ng/mL Interval 1.0 to 11.8	8.1 ng/mL Interval 7.5 to 99.99
Creatinine Kinase - Muscle/Brain (MB) (ng/mL) 48H	4.75 ng/mL Interval 2.0 to 8.99	6 ng/mL Interval 6.0 to 6.0

SECONDARY outcome

Timeframe: 18 Months

Clinically significant laboratory values are first determined via standard laboratory normal values from a CAP and CLIA certified Laboratory and then assessed by investigator based on specific patient conditions and disease state.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=2 Participants Participants who received placebo injections.
Number of Clinically Significant Laboratory Values Clinically Significant Urinalysis Values	0 Incidents	0 Incidents
Number of Clinically Significant Laboratory Values Clinically Significant Hematology Values	6 Incidents	0 Incidents
Number of Clinically Significant Laboratory Values Clinically Significant Clinical Chemistry Values	9 Incidents	0 Incidents

SECONDARY outcome

Timeframe: Assessed at 6 Months, 12 Months, and 18 Months

Rate of Treatment Emergent Adverse Events Post Coronary Artery Bypass Graft (CABG) at 6 Months, 12 Months, and 18 Months

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Rate of Treatment Emergent Adverse Events 6 Months Post CABG	9.5 Number of Adverse Events Interval 1.0 to 30.0	5.0 Number of Adverse Events Interval 1.0 to 10.0
Rate of Treatment Emergent Adverse Events 12 Months Post CABG	10.0 Number of Adverse Events Interval 1.0 to 33.0	5.7 Number of Adverse Events Interval 1.0 to 11.0
Rate of Treatment Emergent Adverse Events 18 Months Post CABG	11 Number of Adverse Events Interval 1.0 to 36.0	6 Number of Adverse Events Interval 1.0 to 11.0

SECONDARY outcome

Timeframe: Day 2

Population: Due to the early termination of the study, there was an insufficient sample size of the Low and High dose of MSCs participants. The statistical analysis plan was revised to combine dose groups to make a comparison to placebo subjects.

The number of abnormal Echocardiogram readings 2 Days Post CABG will be documented based on transthoracic Echocardiographic standards. However, although Echocardiograms 2 days post CABG operation may show abnormalities which is standard in this population, this testing is instrumental because it measures End- diastolic wall thickness and Left ventricular volumes at end-diastole and end-systole.

Outcome measures

Outcome measures
Measure	Treated Group (Low/High Doses) n=6 Participants Participants who received mesenchymal stem cell injections.	Placebo Group n=3 Participants Participants who received placebo injections.
Number of Abnormal Echocardiogram Readings 2 Days Post CABG.	6 Abnormal Echocardiograms	3 Abnormal Echocardiograms

Adverse Events

(1) Lower MSC Dose

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

(2) Higher MSC Dose

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

(3) Placebo Injection

Serious events: 3 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	(1) Lower MSC Dose n=2 participants at risk Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.	(2) Higher MSC Dose n=4 participants at risk Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.	(3) Placebo Injection n=3 participants at risk Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
Cardiac disorders Atrioventricular block complete	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Cardiac disorders Ventricular tachycardia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	33.3% 1/3 • Number of events 3 • 18 Months
Gastrointestinal disorders Large intestine perforation	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Immune system disorders Hypersensitivity	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Injury, poisoning and procedural complications Post procedural hemorrhage	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Injury, poisoning and procedural complications Procedural site reaction	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Hypoaesthesia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Transient ischemic attack	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Renal and urinary disorders Renal failure	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Surgical and medical procedures Debridement	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Vascular disorders Hypotension	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Vascular disorders Ischemia	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 2 • 18 Months

Other adverse events

Other adverse events
Measure	(1) Lower MSC Dose n=2 participants at risk Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery.	(2) Higher MSC Dose n=4 participants at risk Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery.	(3) Placebo Injection n=3 participants at risk Participants will receive placebo injections Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).
Blood and lymphatic system disorders Anemia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Cardiac disorders Arrhythmia	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Cardiac disorders Atrial fibrillation	0.00% 0/2 • 18 Months	50.0% 2/4 • Number of events 2 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Cardiac disorders Bradycardia	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Cardiac disorders Palpitations	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Cardiac disorders Pericardial effusion	50.0% 1/2 • Number of events 1 • 18 Months	0.00% 0/4 • 18 Months	0.00% 0/3 • 18 Months
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Gastrointestinal disorders Ileus	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
General disorders Chest discomfort	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
General disorders Chest pain	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
General disorders Oedema peripheral	0.00% 0/2 • 18 Months	50.0% 2/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
General disorders Pyrexia	0.00% 0/2 • 18 Months	50.0% 2/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
General disorders Tenderness	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Infections and infestations Nasopharyngitis	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
Infections and infestations Pneumonia	50.0% 1/2 • Number of events 1 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Injury, poisoning and procedural complications Back Injury	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Investigations Blood triglycerides abnormal	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Investigations Hematocrit decreased	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Investigations Hepatic enzyme increased	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Investigations White blood cell count increased	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 3 • 18 Months	0.00% 0/3 • 18 Months
Metabolism and nutrition disorders Acidosis	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
Metabolism and nutrition disorders Fluid overload	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Metabolism and nutrition disorders Hypokalemia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • Number of events 1 • 18 Months	0.00% 0/4 • 18 Months	0.00% 0/3 • 18 Months
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 1/2 • Number of events 1 • 18 Months	50.0% 2/4 • Number of events 2 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Nervous system disorders Ageusia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Dizziness	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Dizziness postural	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Headache	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Hypoaesthesia	50.0% 1/2 • Number of events 1 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Nervous system disorders Neuropathy peripheral	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Psychiatric disorders Hallucination	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Renal and urinary disorders Renal failure	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Reproductive system and breast disorders Erection increased	50.0% 1/2 • Number of events 1 • 18 Months	0.00% 0/4 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 2 • 18 Months	0.00% 0/3 • 18 Months
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/2 • 18 Months	0.00% 0/4 • 18 Months	33.3% 1/3 • Number of events 1 • 18 Months
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months
Surgical and medical procedures Hematoma evacuation	50.0% 1/2 • Number of events 1 • 18 Months	0.00% 0/4 • 18 Months	0.00% 0/3 • 18 Months
Vascular disorders Hypotension	0.00% 0/2 • 18 Months	25.0% 1/4 • Number of events 1 • 18 Months	0.00% 0/3 • 18 Months

Additional Information

Adam Mendizabal

EMMES Corporation

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place