Trial Outcomes & Findings for The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study) (NCT NCT02013674)
NCT ID: NCT02013674
Last Updated: 2020-02-11
Results Overview
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
One month post-catheterization
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
Group 1: 20 Million Allogeneic hMSCs
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1: 20 Million Allogeneic hMSCs
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
The TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis STudy (The TRIDENT Study)
Baseline characteristics by cohort
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
65.6 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Enrollment Ejection Fraction (%)
|
31.5 percentage
STANDARD_DEVIATION 9.9 • n=5 Participants
|
26.7 percentage
STANDARD_DEVIATION 6.5 • n=7 Participants
|
29.1 percentage
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Enrollment Glomerular Filtration Rate (mL/Min)
|
70.0 mL/min
STANDARD_DEVIATION 24.4 • n=5 Participants
|
79.2 mL/min
STANDARD_DEVIATION 20.4 • n=7 Participants
|
74.6 mL/min
STANDARD_DEVIATION 22.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: One month post-catheterizationPopulation: SAEs are collected for 12 months, however, outcome 1 is only for SAEs during the first month.
Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Participants With Treatment-emergent Serious Adverse Events (SAE).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Not all participants were able to complete procedure.
Determined by delayed contrast enhanced Computed Tomography (CT) Scan
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Infarct Scar Size (ISS)
Baseline
|
9.9 Percent of Left Ventricular Mass
Interval 6.5 to 16.6
|
9.7 Percent of Left Ventricular Mass
Interval 6.5 to 12.3
|
|
Infarct Scar Size (ISS)
12 Months
|
6.8 Percent of Left Ventricular Mass
Interval 4.5 to 8.6
|
5.6 Percent of Left Ventricular Mass
Interval 4.7 to 6.9
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: Not all participants were able to complete procedure.
Tissue perfusion measured by CT.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Participant With Reported Tissue Perfusion
at 6 months
|
0 Participants
|
0 Participants
|
|
Number of Participant With Reported Tissue Perfusion
at 12 months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Not all participants were able to complete procedure.
Peak VO2 assessed via treadmill determination.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Peak Oxygen Consumption (VO2)
Baseline
|
15.8 mL/kg/min
Standard Deviation 5.15
|
16.7 mL/kg/min
Standard Deviation 4.48
|
|
Peak Oxygen Consumption (VO2)
6 months
|
15.0 mL/kg/min
Standard Deviation 5.27
|
16.5 mL/kg/min
Standard Deviation 5.30
|
|
Peak Oxygen Consumption (VO2)
12 months
|
14.4 mL/kg/min
Standard Deviation 4.94
|
16.3 mL/kg/min
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 monthsPopulation: Not all participants were able to complete procedure.
A test that measures how far a patient can walk in 6 minutes.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Six-minute Walk Test.
6 months
|
416.4 Meters
Standard Deviation 107.76
|
453.6 Meters
Standard Deviation 126.82
|
|
Six-minute Walk Test.
Baseline
|
398.7 Meters
Standard Deviation 111.62
|
434.9 Meters
Standard Deviation 120.04
|
|
Six-minute Walk Test.
3 months
|
396.1 Meters
Standard Deviation 109.62
|
433.5 Meters
Standard Deviation 133.97
|
|
Six-minute Walk Test.
12 months
|
409.7 Meters
Standard Deviation 130.19
|
463.0 Meters
Standard Deviation 143.07
|
SECONDARY outcome
Timeframe: Baseline to 3 months, Baseline to 6 months, Baseline to 12 monthsPopulation: Not all participants were able to complete procedure.
Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 6 months, Unchanged
|
7 Participants
|
8 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 12 months, Unchanged
|
8 Participants
|
4 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 3 months, Improved
|
2 Participants
|
4 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 3 months, Unchanged
|
10 Participants
|
9 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 3 months, Worsened
|
3 Participants
|
2 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 6 months, Improved
|
5 Participants
|
4 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 6 months, Worsened
|
2 Participants
|
2 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 12 months, Improved
|
5 Participants
|
6 Participants
|
|
Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.
Baseline to 12 months, Worsened
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 month, 6 months, 12 months post injection.Population: Not all participants were able to complete study.
Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Incidents of Major Adverse Cardiac Events (MACE).
1 month from injection
|
0 Incidents
|
0 Incidents
|
|
Number of Incidents of Major Adverse Cardiac Events (MACE).
6 months from injection
|
3 Incidents
|
2 Incidents
|
|
Number of Incidents of Major Adverse Cardiac Events (MACE).
12 months from injection
|
3 Incidents
|
2 Incidents
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: Not all participants were able to complete the study.
Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (AE)
Treatment emergent AE (6 month)
|
8 Participants
|
10 Participants
|
|
Number of Participants With Treatment Emergent Adverse Event (AE)
Treatment emergent AE (12 months)
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 monthsPopulation: Not all participants were able to complete procedure.
Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
Baseline
|
29.0 score on a scale
Interval 21.0 to 52.0
|
35.0 score on a scale
Interval 6.0 to 60.0
|
|
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
3 months
|
22.0 score on a scale
Interval 10.0 to 51.0
|
20.0 score on a scale
Interval 6.0 to 40.0
|
|
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
6 months
|
30.0 score on a scale
Interval 16.0 to 53.0
|
21.5 score on a scale
Interval 9.0 to 34.0
|
|
Minnesota Living With Heart Failure (MLHF) Questionnaire Scores
12 months
|
25.0 score on a scale
Interval 4.0 to 41.0
|
15.0 score on a scale
Interval 8.0 to 64.0
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: Not all participants were able to complete the procedure.
Left ventricular end diastolic wall thickness as determined by echocardiogram.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Echocardiographic-derived Measures of Left Ventricular Function
Month 12
|
6.1 centimeters (cm)
Interval 5.4 to 6.9
|
6.2 centimeters (cm)
Interval 5.4 to 6.6
|
|
Echocardiographic-derived Measures of Left Ventricular Function
Month 6
|
5.8 centimeters (cm)
Interval 5.2 to 6.3
|
6.3 centimeters (cm)
Interval 5.7 to 6.6
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
As determined by Computed Tomography Scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
As determined by Computed Tomography Scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
As determined by Computed Tomography Scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Not all participants were able to complete the procedure.
Change in 1-year LVEF by CT as compared to baseline.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=12 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=13 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Difference Between the Left Ventricular Ejection Fraction (LVEF)
|
-0.27 Percentage of ejected blood
Interval -12.25 to 32.17
|
3.00 Percentage of ejected blood
Interval -8.27 to 10.33
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
As assessed via ECHO
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Not all participants were able to complete the procedure.
Difference in left ventricular end diastolic and end systolic volume will be assessed via CT
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=12 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=13 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Difference in Left Ventricular Volume
|
7.65 ml
Interval -15.89 to 44.76
|
3.70 ml
Interval -43.85 to 53.66
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
As measured via myocardial mass by CT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Not all participants were able to complete the procedure.
The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
baseline, normal
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
baseline, abnormal not clinically significant
|
15 Participants
|
14 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
baseline, abnormal, clinically significant
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
12 months, normal
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
12 months, abnormal not clinically significant
|
12 Participants
|
14 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Reads.
12 months, abnormal, clinically significant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data were not available to perform the statistical analyses as described in the protocol for this outcome.
Clinical significance of abnormal lab values will be assessed by treating physician
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 hours, 24 hours post cardiac catheterizationPopulation: Not all participants were able to complete the procedure.
Serial Troponin I values in ng/mL over time.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Serial Troponin I
12-hours post-catheterization
|
0.01 ng/ml
Interval 0.01 to 0.1
|
0.01 ng/ml
Interval 0.01 to 0.03
|
|
Serial Troponin I
24-hours post-catheterization
|
0.06 ng/ml
Interval 0.01 to 0.29
|
0.05 ng/ml
Interval 0.01 to 0.18
|
SECONDARY outcome
Timeframe: 6 hours post cardiac catheterizationPopulation: Not all participants were able to complete the procedure.
The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=7 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=8 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Number of Participants With Abnormal ECHO Reading
Normal
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal ECHO Reading
Abnormal, Not Clinically Significant
|
6 Participants
|
6 Participants
|
|
Number of Participants With Abnormal ECHO Reading
Abnormal, Clinically Significant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 hours, 24 hours post cardiac catheterizationPopulation: Not all participants were able to complete the procedure.
CK-MB values in ng/mL over time.
Outcome measures
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 Participants
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Creatinine Kinase Muscle/Brain (CK-MB)
12 hour post catheterization
|
3.25 ng/ml
Interval 1.5 to 27.3
|
2.45 ng/ml
Interval 1.2 to 6.2
|
|
Creatinine Kinase Muscle/Brain (CK-MB)
24 hour post catheterization
|
4.20 ng/ml
Interval 2.4 to 19.3
|
4.40 ng/ml
Interval 2.4 to 11.1
|
Adverse Events
Group 1: 20 Million Allogeneic hMSCs
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: 100 Million Allogeneic hMSCs
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 participants at risk
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 participants at risk
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Arterisolerosis
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Cardiac failure
|
13.3%
2/15 • Number of events 2 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
cardiac failure congestive
|
20.0%
3/15 • Number of events 3 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
Other adverse events
| Measure |
Group 1: 20 Million Allogeneic hMSCs
n=15 participants at risk
Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10\^8 (20 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
Group 2: 100 Million Allogeneic hMSCs
n=15 participants at risk
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10\^8 (100 million) Allo-hMSCs.
Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Cardiac failure
|
26.7%
4/15 • Number of events 4 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Cardiac failure congestive
|
20.0%
3/15 • Number of events 3 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
13.3%
2/15 • Number of events 2 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Cardiac disorders
Sinus Arrest
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Eye disorders
Eye Swelling
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
General disorders
Gait disturbance
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Infections and infestations
Hordeolum
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Infections and infestations
Rhinitis
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Investigations
Prostatic specific antigen
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 2 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Musculoskeletal and connective tissue disorders
Inguinal Mass
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
13.3%
2/15 • Number of events 2 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
20.0%
3/15 • Number of events 3 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
13.3%
2/15 • Number of events 2 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Skin and subcutaneous tissue disorders
Stasis dematitis
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
General disorders
Chest Pain
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Infections and infestations
Chronic Sinusitis
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Surgical and medical procedures
Impantable defibrillator replacement
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
|
Musculoskeletal and connective tissue disorders
Spinal column ste
|
6.7%
1/15 • Number of events 1 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
0.00%
0/15 • Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
|
Additional Information
Marietsy pujol / Senior Regulatory Specialist
ISCI / University of Miami Miller School of Medicine
Phone: 305-243-7273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place