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Trial record 19 of 971 for:    stem cells | Studies With Results

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00587990
Recruitment Status : Terminated (Difficulty in recruitment.)
First Posted : January 8, 2008
Results First Posted : April 2, 2015
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University Specialized Center for Cell Based Therapy
The Emmes Company, LLC
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Stem Cell Transplantation
Ventricular Dysfunction, Left
Interventions Biological: Lower dose mesenchymal stem cell (MSC) injection
Genetic: Placebo
Biological: Higher dose MSC injection
Enrollment 9
Recruitment Details  
Pre-assignment Details This trial, which originally was designed to enroll 45 patients, was suspended after 9 patients were enrolled because of slow accrual.
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Hide Arm/Group Description

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.

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.

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).

Period Title: Overall Study
Started 2 4 3
Completed 2 4 2
Not Completed 0 0 1
Reason Not Completed
Death             0             0             1
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 4 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 3 participants 9 participants
60.3668720  (13.4742319) 51.9240246  (9.1760352) 63.6276523  (2.9733072) 57.7014222  (9.3869460)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
4
 100.0%
3
 100.0%
9
 100.0%
1.Primary Outcome
Title Number of Patients With Serious Adverse Events
Hide Description 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.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  33.3%
2.Secondary Outcome
Title Change in Infarct Scar Size (ISS) Over 18 Month Period
Hide Description Change in infarct scar size (ISS) between baseline and 6-month and 18 month visits as determined by delayed contrast-enhanced MRI.
Time Frame Baseline, 6 Months, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: Grams (g)
6 Months Number Analyzed 6 participants 2 participants
-2.37
(-5.64 to .89)
-2.16
(-40.53 to 36.21)
18 Months Number Analyzed 5 participants 2 participants
-5.91
(-8.85 to -2.97)
-5.32
(-78.25 to 67.61)
3.Secondary Outcome
Title Left Ventricular Function (LVF) in Region of MSC Injection
Hide Description The Left Ventricular Function differences in the region of MSC injection were evaluated. LVF is evaluated via ECHO as the percentage of ejected blood.
Time Frame Assessed at Baseline and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: percentage of ejected blood
Baseline -15.26  (3.15) -18.53  (2.71)
18 Months -21.13  (1.68) -19.66  (1.07)
4.Secondary Outcome
Title Regional Left Ventricular Wall Thickening
Hide Description Difference between baseline and 18 month regional left ventricular wall thickening as determined by MRI.
Time Frame Assessed at Baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: mm
Baseline 20.68  (6.67) 32.21  (9.97)
18 Months 47.87  (9.45) 42.09  (9.49)
5.Secondary Outcome
Title Left Ventricular End Diastolic Wall Thickness
Hide Description Difference between the baseline and 18 month left ventricular end diastolic wall thickness as determined by MRI and echocardiogram.
Time Frame Assessed at Baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (Standard Error)
Unit of Measure: mm
Baseline 5.86  (.46) 16.15  (2.72)
18 Months 6.17  (.48) 18.54  (1.55)
6.Secondary Outcome
Title Change in Left Ventricular End Diastolic and Systolic Volume
Hide Description Change in left ventricular end diastolic and systolic volume as determined by MRI and echocardiogram.
Time Frame Baseline, 6 Months, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: ml
End Diastolic Volume from Baseline to 6 Months
192.92
(115.91 to 281.93)
169.63
(-468.29 to 807.54)
End Diastolic from 6 Month to 18 Month
218.73
(98.85 to 338.61)
172.01
(-245.46 to 589.47)
End Systolic Volume from Baseline to 6 Months
130.09
(46.47 to 213.71)
97.13
(-416.33 to 610.59)
End Systolic from 6 Month to 18 Month
135.99
(29.07 to 242.90)
94.90
(-307.45 to 497.24)
7.Secondary Outcome
Title Change in Left Ventricular Ejection Fraction
Hide Description Change between baseline to 6-month and 18-month left ventricular ejection fraction (LVEF) as determined by MRI and echocardiogram.
Time Frame Baseline to 6 Months, Baseline to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: percentage of Ejection Fraction
Baseline to 6 Months
-.34
(-6.6 to 5.92)
13.18
(-68.65 to 95.01)
Baseline to 18 Months
2.50
(-3.35 to 8.34)
14.61
(-59.15 to 88.36)
8.Secondary Outcome
Title Change in Peak Volume Oxygen
Hide Description Change in Peak VO2 as determined by treadmill test (mL/mg/min) from Baseline to 6 and from baseline to 18 months
Time Frame Baseline, 6 Months, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: (mL/mg/min)
Baseline to 6 Months
.2
(-1.1 to 1.4)
-.2
(-12.9 to 12.5)
Baseline to 18 Months
-.2
(-1.8 to 1.3)
-.4
(-10.6 to 9.8)
9.Secondary Outcome
Title Change in Six Minute Walk Test
Hide Description Change in Six Minute Walk Test (in meters) from Baseline to 6 Months and Baseline to 18 Months
Time Frame Baseline, 6 Months, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Median (95% Confidence Interval)
Unit of Measure: Meters
Baseline to 6 Months
67
(-453.0 to 309.0)
-30.00
(-30.00 to -30.00)
Baseline to 18 Months
67
(-199.0 to 309.0)
-33.0
(-36 to -30)
10.Secondary Outcome
Title Change in NYHA Functional Class
Hide Description

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

Time Frame Baseline to 6 Months, 6 months to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline to 6 Months, Worsened Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
Baseline to 6 Months, Improved Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
Baseline to 6 Months, Unchanged Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
6 Months to 18 Months, Worsened Number Analyzed 5 participants 2 participants
2
  40.0%
0
   0.0%
6 Months to 18 Months, Improved Number Analyzed 5 participants 2 participants
0
   0.0%
1
  50.0%
6 Months to 18 Months, Unchanged Number Analyzed 5 participants 2 participants
3
  60.0%
1
  50.0%
11.Secondary Outcome
Title Minnesota Living With Heart Failure Questionnaire Scores
Hide Description 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.
Time Frame Assessed at 6 Months and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
6 Month Visit
11.5
(-10.8 to 33.8)
54.5
(-66.2 to 175.2)
18 Month Visit
7.3
(-3.6 to 18.3)
10.5
(-122.9 to 143.9)
12.Secondary Outcome
Title Incidence of Major Adverse Cardiac Events (MACE)
Hide Description Incidence of Major Adverse Cardiac Events (MACE). A composite incidence of (1) death, (2) hospitalization for heart failure, or (3) non-fatal recurrent Ml.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: # of Major Adverse Cardiac Events (MACE)
0 1
13.Secondary Outcome
Title Number of Participants With Abnormal 48-Hour Ambulatory ECG Recordings
Hide Description

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.

Time Frame Assessed at 6 Months, 12 Months, and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
6 Month Visit Number Analyzed 6 participants 2 participants
4
  66.7%
2
 100.0%
12 Month Visit Number Analyzed 3 participants 2 participants
3
 100.0%
2
 100.0%
18 Month Visit Number Analyzed 5 participants 2 participants
5
 100.0%
2
 100.0%
14.Secondary Outcome
Title Change in Pulmonary Function
Hide Description 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)
Time Frame Baseline, 6 Months, 12 Months, 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Mean (95% Confidence Interval)
Unit of Measure: Liters
Baseline to 6 Months
-7.2
(-16.3 to 1.9)
7.0
(-81.9 to 95.9)
Baseline to 12 Months
-8.5
(-18.9 to 1.9)
-5.5
(-62.7 to 51.7)
Baseline to 18 Months
-7.2
(-23.1 to 8.8)
7.5
(-176.7 to 191.7)
15.Secondary Outcome
Title Serial Troponin Values (ng/mL)
Hide Description Serial Troponin Values (ng/mL) Values from Baseline to 48 Hours Post CABG
Time Frame Assessed at Baseline, 12 hours, 24 hours, 36 hours, and 48 hours post CABG
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Median (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline
.01
(.01 to .25)
.01
(0 to .01)
12H
.76
(.03 to 2.0)
.76
(.18 to 1.26)
24H
.35
(.16 to 3.31)
.1
(.03 to .49)
36H
.55
(.23 to 2.23)
.36
(.13 to 1.57)
48H
.21
(.14 to 4.44)
.2
(.2 to .2)
16.Secondary Outcome
Title Creatinine Kinase - Muscle/Brain (MB) (ng/mL)
Hide Description Creatinine Kinase MB (ng/mL) Values every 12 hours from Baseline to 48 Hours Post CABG
Time Frame Assessed at Baseline, 12 Hours, 24 Hours, 36 Hours, and 48 hours post CABG
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Median (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline
2.2
(.7 to 8.10)
2.6
(2.44 to 3.00)
12H
19.6
(9 to 32.10)
24.75
(16.9 to 30.8)
24H
12.39
(3 to 21.60)
15.5
(11.5 to 66.28)
36H
8.04
(1 to 11.80)
8.1
(7.5 to 99.99)
48H
4.75
(2 to 8.99)
6
(6 to 6)
17.Secondary Outcome
Title Number of Clinically Significant Laboratory Values
Hide Description 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.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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. One placebo subject expired Day 3 post injection.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 2
Measure Type: Number
Unit of Measure: Incidents
Clinically Significant Hematology Values 6 0
Clinically Significant Clinical Chemistry Values 9 0
Clinically Significant Urinalysis Values 0 0
18.Secondary Outcome
Title Rate of Treatment Emergent Adverse Events
Hide Description Rate of Treatment Emergent Adverse Events Post Coronary Artery Bypass Graft (CABG) at 6 Months, 12 Months, and 18 Months
Time Frame Assessed at 6 Months, 12 Months, and 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Mean (95% Confidence Interval)
Unit of Measure: Number of Adverse Events
6 Months Post CABG
9.5
(1 to 30)
5.0
(1 to 10)
12 Months Post CABG
10.0
(1 to 33)
5.7
(1 to 11)
18 Months Post CABG
11
(1 to 36)
6
(1 to 11)
19.Secondary Outcome
Title Number of Abnormal Echocardiogram Readings 2 Days Post CABG.
Hide Description 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.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treated Group (Low/High Doses) Placebo Group
Hide Arm/Group Description:
Participants who received mesenchymal stem cell injections.
Participants who received placebo injections.
Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: Abnormal Echocardiograms
6 3
Time Frame 18 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title (1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Hide Arm/Group Description

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.

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.

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).

All-Cause Mortality
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/4 (0.00%)      1/3 (33.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      2/4 (50.00%)      3/3 (100.00%)    
Cardiac disorders       
Atrioventricular block complete   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Ventricular tachycardia   0/2 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  3
Gastrointestinal disorders       
Large intestine perforation   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Immune system disorders       
Hypersensitivity   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Injury, poisoning and procedural complications       
Post procedural hemorrhage   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Procedural site reaction   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Metabolism and nutrition disorders       
Hyperkalemia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Nervous system disorders       
Hypoaesthesia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Transient ischemic attack   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Renal and urinary disorders       
Renal failure   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Haemothorax   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Respiratory arrest   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Surgical and medical procedures       
Debridement   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Vascular disorders       
Hypotension   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Ischemia   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
(1) Lower MSC Dose (2) Higher MSC Dose (3) Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      4/4 (100.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders       
Anemia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Cardiac disorders       
Arrhythmia   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Atrial fibrillation   0/2 (0.00%)  0 2/4 (50.00%)  2 1/3 (33.33%)  1
Bradycardia   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Palpitations   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Pericardial effusion   1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders       
Constipation   1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Ileus   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
General disorders       
Chest discomfort   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Chest pain   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Oedema peripheral   0/2 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0
Pyrexia   0/2 (0.00%)  0 2/4 (50.00%)  2 0/3 (0.00%)  0
Tenderness   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations       
Nasopharyngitis   0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pneumonia   1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Back Injury   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Procedural pain   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Investigations       
Blood triglycerides abnormal   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hematocrit decreased   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hepatic enzyme increased   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
White blood cell count increased   0/2 (0.00%)  0 1/4 (25.00%)  3 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Acidosis   0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Fluid overload   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hyperkalemia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypokalemia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Myalgia   1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Pain in extremity   1/2 (50.00%)  1 2/4 (50.00%)  2 1/3 (33.33%)  1
Nervous system disorders       
Ageusia   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dizziness   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dizziness postural   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Headache   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypoaesthesia   1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0
Neuropathy peripheral   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Psychiatric disorders       
Hallucination   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Renal and urinary disorders       
Renal failure   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Reproductive system and breast disorders       
Erection increased   1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Atelectasis   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Dyspnea   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Hypoxia   0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pleural effusion   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Pneumothorax   0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Pulmonary congestion   0/2 (0.00%)  0 1/4 (25.00%)  2 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Exfoliative rash   0/2 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1
Rash   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Surgical and medical procedures       
Hematoma evacuation   1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Hypotension   0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
Limitations due to slow enrollment and premature closure.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Mendizabal
Organization: EMMES Corporation
Phone: 301-251-1161 ext 221
EMail: amendizabal@emmes.com
Layout table for additonal information
Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT00587990     History of Changes
Other Study ID Numbers: 20070598
U54HL081028 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2008
First Posted: January 8, 2008
Results First Submitted: January 30, 2015
Results First Posted: April 2, 2015
Last Update Posted: September 10, 2019