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The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT) (TAC-HFT)

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ClinicalTrials.gov Identifier: NCT00768066
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
The EMMES Corporation
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: Autologous human mesenchymal cells (hMSCs)
Biological: Autologous human bone marrow cells (hBMCs)
Biological: Placebo
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Period Title: Overall Study
Started 22 22 21
Completed 19 19 21
Not Completed 3 3 0
Reason Not Completed
Did not receive study product injection.             3             3             0
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf Total
Hide Arm/Group Description Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Total of all reporting groups
Overall Number of Baseline Participants 19 19 21 59
Hide Baseline Analysis Population Description
This is the number of patients who were randomized and received the study product injection.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 21 participants 59 participants
57.1  (10.6) 61.1  (8.4) 60.6  (10.4) 59.6  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Female
1
   5.3%
2
  10.5%
1
   4.8%
4
   6.8%
Male
18
  94.7%
17
  89.5%
20
  95.2%
55
  93.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Hispanic or Latino
7
  36.8%
10
  52.6%
9
  42.9%
26
  44.1%
Not Hispanic or Latino
11
  57.9%
9
  47.4%
12
  57.1%
32
  54.2%
Unknown or Not Reported
1
   5.3%
0
   0.0%
0
   0.0%
1
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
American Indian or Alaska Native
1
   5.3%
0
   0.0%
0
   0.0%
1
   1.7%
Asian
1
   5.3%
0
   0.0%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.3%
0
   0.0%
1
   4.8%
2
   3.4%
White
16
  84.2%
18
  94.7%
20
  95.2%
54
  91.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   5.3%
0
   0.0%
1
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 21 participants 59 participants
19 19 21 59
Qualifying ejection fraction, %  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 19 participants 19 participants 21 participants 59 participants
35.8  (8.5) 36.3  (11.1) 33.0  (9.6) 34.9  (9.7)
History of Coronary Interventions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 19 18 20 57
No 0 1 1 2
History of Atrial/Ventricular Arrhythmia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 5 4 6 15
No 14 15 15 44
History of Hyptertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 12 12 16 40
No 7 7 5 19
History of Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 3 4 7 14
No 16 15 14 45
History of Congestive Heart Failure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 11 16 16 43
No 8 3 5 16
History of Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Yes 14 10 16 40
No 5 9 5 19
New York Heart Association Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
I 5 5 4 14
II 12 10 10 32
III 2 4 4 10
Unknown 0 0 3 3
[1]
Measure Description: New York Heart Association Funcational classificaiton classifies the extent of heart failure in a patient. The 4 categories are based on how much patients are limited by physical activity, breathing, shortness of breath and/or angina pain. A class of 1 is a better New York Heart Association Class and a class of 4 is a worse New York Heart Association Class.
Distance Walked in 6-Minutes  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 19 participants 19 participants 21 participants 59 participants
415.3  (67.9) 399.6  (95.0) 388.1  (58.4) 400.6  (74.4)
Peak VO2  
Mean (Standard Deviation)
Unit of measure:  mL/kg/min
Number Analyzed 19 participants 19 participants 21 participants 59 participants
18.8  (3.8) 17.3  (4.4) 14.6  (5.6) 16.7  (5.0)
Predicted FEV1  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 19 participants 19 participants 21 participants 59 participants
86.2  (15.7) 83.2  (23.2) 79.1  (20.1) 82.7  (19.8)
Device   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
Automatic implanted cardioverter-defribillator 10 10 8 28
Biventricular Pacing 1 1 3 5
None 8 8 10 26
[1]
Measure Description: Type of cardiac device participant had at baseline.
Imaging Modality   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 21 participants 59 participants
MRI 13 13 15 41
CT 6 6 6 18
[1]
Measure Description: Type of cardiac imaging modality specified for the participant at baseline.
1.Primary Outcome
Title Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation
Hide Description [Not Specified]
Time Frame one month post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Measure Type: Number
Unit of Measure: participants
Yes 0 0 0
No 19 19 21
2.Secondary Outcome
Title Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).
Hide Description [Not Specified]
Time Frame Measured every 12 hours for the first 48 hours post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline
0.06
(0.02 to 0.10)
0.06
(0.02 to 0.11)
0.11
(0.00 to 0.25)
12-hours post-catheterization
0.82
(0.47 to 1.17)
1.03
(0.06 to 1.99)
0.98
(0.49 to 1.47)
24-hours post-catheterization
0.60
(0.29 to 0.91)
0.45
(0.04 to 0.86)
0.42
(0.18 to 0.67)
36-hours post-catheterization
0.39
(0.16 to 0.62)
0.29
(0.01 to 0.57)
0.31
(0.13 to 0.49)
48-hours post-catheterization
0.31
(0.08 to 0.54)
0.25
(0.01 to 0.49)
0.22
(0.06 to 0.38)
3.Secondary Outcome
Title Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).
Hide Description [Not Specified]
Time Frame Measured every 12 hours for the first 48 hours post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
Baseline
1.61
(1.21 to 2.02)
1.36
(0.80 to 1.91)
1.64
(1.17 to 2.11)
12-hours post-catheterization
3.75
(2.70 to 4.80)
2.98
(2.17 to 3.79)
4.41
(2.31 to 6.51)
24-hours post-catheterization
2.19
(1.64 to 2.74)
1.73
(1.23 to 2.24)
2.85
(1.40 to 4.29)
36-hours post-catheterization
1.38
(1.11 to 1.66)
1.28
(0.98 to 1.59)
1.63
(1.03 to 2.23)
48-hours post-catheterization
1.05
(0.84 to 1.27)
1.03
(0.79 to 1.26)
1.36
(0.81 to 1.91)
4.Secondary Outcome
Title Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI.
Hide Description [Not Specified]
Time Frame 12 months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Measure Type: Number
Unit of Measure: participants
Yes 1 0 2
No 18 19 19
5.Secondary Outcome
Title Ectopic Tissue Formation.
Hide Description [Not Specified]
Time Frame 12 months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Measure Type: Number
Unit of Measure: participants
Yes 0 0 0
No 19 19 21
6.Secondary Outcome
Title Number of Deaths
Hide Description [Not Specified]
Time Frame 12-months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 19 19 21
Measure Type: Number
Unit of Measure: participants
Yes 1 0 1
No 18 19 20
7.Secondary Outcome
Title Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).
Hide Description Data provided are with respect to the change from baseline at 12-months post-catheterization.
Time Frame 12 months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 16 17 19
Mean (95% Confidence Interval)
Unit of Measure: meters
32.6
(-4.6 to 69.7)
16.9
(-14.2 to 48.0)
6.3
(-31.4 to 44.0)
8.Secondary Outcome
Title Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.
Hide Description Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.
Time Frame 12 months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 16 17 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-6.3
(-15.0 to 2.4)
-8.2
(-17.4 to 0.97)
0.4
(-9.5 to 10.3)
9.Secondary Outcome
Title Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.
Hide Description Data provided are with respect to the change from baseline at 12-months post-catheterization.
Time Frame 12 Months post-catheterization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description:
Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
Overall Number of Participants Analyzed 14 15 16
Mean (95% Confidence Interval)
Unit of Measure: percent change
-18.9
(-30.4 to -7.4)
-7.0
(-15.7 to 1.7)
-5.2
(-16.8 to 6.5)
Time Frame 30-days after transendocardial stem cell injection
Adverse Event Reporting Description Adverse events are described by MedDRA preferred term.
 
Arm/Group Title 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Hide Arm/Group Description Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
All-Cause Mortality
200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/19 (10.53%)      2/19 (10.53%)      3/21 (14.29%)    
Cardiac disorders       
Angina Pectoris * 1  1/19 (5.26%)  1 1/19 (5.26%)  1 0/21 (0.00%)  0
Angina unstable * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 2/21 (9.52%)  2
Atrial Fibrillation * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Atrioventricular block complete * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Cardiac arrest * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Intracardiac thrombus * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Ventricular tachycardia * 1  2/19 (10.53%)  2 0/19 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders       
Colitis ulcerative * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
General disorders       
Chest discomfort * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Chest Pain * 1  1/19 (5.26%)  1 1/19 (5.26%)  1 0/21 (0.00%)  0
Device electrical finding * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Device malfunction * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Fibrosis * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations       
Pneumonia * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 1/21 (4.76%)  1
Musculoskeletal and connective tissue disorders       
Back pain * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Intervertebral disc protrusion * 1  0/19 (0.00%)  0 2/19 (10.53%)  2 0/21 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Chronic obstructive pulmonary disease * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Surgical and medical procedures       
Dyspnoea exertional * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Percutaneous coronary intervention * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 200 Million Autologous Human Bone Marrow Cells (hBMCs) Participants Will Receive a Placebo Injection of Phosphate-buf
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/19 (31.58%)      7/19 (36.84%)      5/21 (23.81%)    
Blood and lymphatic system disorders       
Blood and lymphatic system disorders * 1 [1]  2/19 (10.53%)  2 0/19 (0.00%)  0 0/21 (0.00%)  0
Cardiac disorders       
Angina pectoris * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Arrhythmia * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Atrial Fibrillation * 1  1/19 (5.26%)  1 1/19 (5.26%)  1 1/21 (4.76%)  1
Intracardiac thrombus * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Palpitations * 1  1/19 (5.26%)  1 1/19 (5.26%)  1 0/21 (0.00%)  0
Ear and labyrinth disorders       
Vertigo positional * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 1/21 (4.76%)  1
Eye disorders       
Eye inflammation * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders       
Dyspepsia * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Food Poisoning * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
General disorders       
Chest Discomfort * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 1/21 (4.76%)  1
Chest Pain * 1  3/19 (15.79%)  3 1/19 (5.26%)  1 0/21 (0.00%)  0
Device occlusion * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Fatigue * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Malaise * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations       
Atypical pneumonia * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Bronchitis * 1  0/19 (0.00%)  0 2/19 (10.53%)  2 0/21 (0.00%)  0
Nasopharyngitis * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Pneumonia * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Upper respiratory tract infection * 1  1/19 (5.26%)  1 2/19 (10.53%)  2 1/21 (4.76%)  1
Urinary tract infection * 1  0/19 (0.00%)  0 1/19 (5.26%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications       
Injury, Poisoning and procedural complications * 1 [2]  0/19 (0.00%)  0 2/19 (10.53%)  2 1/21 (4.76%)  1
Investigations       
Investigations * 1 [3]  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Metabolism and nutrition disorders       
Metabolism and nutrition disorders * 1 [4]  1/19 (5.26%)  1 1/19 (5.26%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorders * 1 [5]  2/19 (10.53%)  2 0/19 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders       
Nervous system disorders * 1 [6]  1/19 (5.26%)  1 4/19 (21.05%)  5 2/21 (9.52%)  2
Renal and urinary disorders       
Renal failure chronic * 1  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
Reproductive system and breast disorders       
Epididymitis * 1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Respiratory, thoracic and mediastinal disorders * 1 [7]  0/19 (0.00%)  0 0/19 (0.00%)  0 3/21 (14.29%)  3
Skin and subcutaneous tissue disorders       
Skin and subcutaneous tissue disorders * 1 [8]  2/19 (10.53%)  2 2/19 (10.53%)  2 0/21 (0.00%)  0
Surgical and medical procedures       
Surgical and Medical procedures * 1 [9]  0/19 (0.00%)  0 0/19 (0.00%)  0 1/21 (4.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Antiphospholipid syndrome Splenomegaly
[2]
fall laceration skin laceration
[3]
Arteriogram Electrocardiogram abnormal
[4]
Dehydration Gout
[5]
Musculoskeletal pain Myositis
[6]
Amnesia Dizziness Dizziness postural Syncope
[7]
Dyspnoea Pleural effusion
[8]
Pruritus Rash
[9]
- Stent placement
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adam Mendizabal, Biostatistician
Organization: The EMMES Corporation
Phone: 301-251-1161 ext 221
Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT00768066     History of Changes
Other Study ID Numbers: 20070443
First Submitted: October 3, 2008
First Posted: October 7, 2008
Results First Submitted: January 17, 2014
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015