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

This study has been completed.
Sponsor:
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier:
NCT00768066
First received: October 3, 2008
Last updated: November 9, 2015
Last verified: November 2015
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 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.
200 Million Autologous Human Bone Marrow Cells (hBMCs) 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.
Participants Will Receive a Placebo Injection of Phosphate-buf 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.

Participant Flow:   Overall Study
    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  
STARTED     22     22     21  
COMPLETED     19     19     21  
NOT COMPLETED     3     3     0  
Did not receive study product injection.                 3                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This is the number of patients who were randomized and received the study product injection.

Reporting Groups
  Description
200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) 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.
200 Million Autologous Human Bone Marrow Cells (hBMCs) 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.
Participants Will Receive a Placebo Injection of Phosphate-buf 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 Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  19     19     21     59  
Age  
[units: years]
Mean (Standard Deviation)
  57.1  (10.6)     61.1  (8.4)     60.6  (10.4)     59.6  (9.9)  
Gender  
[units: participants]
       
Female     1     2     1     4  
Male     18     17     20     55  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     7     10     9     26  
Not Hispanic or Latino     11     9     12     32  
Unknown or Not Reported     1     0     0     1  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     1     0     0     1  
Asian     1     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     1     0     1     2  
White     16     18     20     54  
More than one race     0     0     0     0  
Unknown or Not Reported     0     1     0     1  
Region of Enrollment  
[units: participants]
       
United States     19     19     21     59  
Qualifying ejection fraction, %  
[units: percent]
Mean (Standard Deviation)
  35.8  (8.5)     36.3  (11.1)     33.0  (9.6)     34.9  (9.7)  
History of Coronary Interventions  
[units: participants]
       
Yes     19     18     20     57  
No     0     1     1     2  
History of Atrial/Ventricular Arrhythmia  
[units: participants]
       
Yes     5     4     6     15  
No     14     15     15     44  
History of Hyptertension  
[units: participants]
       
Yes     12     12     16     40  
No     7     7     5     19  
History of Diabetes  
[units: participants]
       
Yes     3     4     7     14  
No     16     15     14     45  
History of Congestive Heart Failure  
[units: participants]
       
Yes     11     16     16     43  
No     8     3     5     16  
History of Smoking  
[units: participants]
       
Yes     14     10     16     40  
No     5     9     5     19  
New York Heart Association Class [1]
[units: participants]
       
I     5     5     4     14  
II     12     10     10     32  
III     2     4     4     10  
Unknown     0     0     3     3  
Distance Walked in 6-Minutes  
[units: meters]
Mean (Standard Deviation)
  415.3  (67.9)     399.6  (95.0)     388.1  (58.4)     400.6  (74.4)  
Peak VO2  
[units: mL/kg/min]
Mean (Standard Deviation)
  18.8  (3.8)     17.3  (4.4)     14.6  (5.6)     16.7  (5.0)  
Predicted FEV1  
[units: percent]
Mean (Standard Deviation)
  86.2  (15.7)     83.2  (23.2)     79.1  (20.1)     82.7  (19.8)  
Device [2]
[units: participants]
       
Automatic implanted cardioverter-defribillator     10     10     8     28  
Biventricular Pacing     1     1     3     5  
None     8     8     10     26  
Imaging Modality [3]
[units: participants]
       
MRI     13     13     15     41  
CT     6     6     6     18  
[1] 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.
[2] Type of cardiac device participant had at baseline.
[3] Type of cardiac imaging modality specified for the participant at baseline.



  Outcome Measures
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1.  Primary:   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   [ Time Frame: one month post-catheterization ]

2.  Secondary:   Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization).   [ Time Frame: Measured every 12 hours for the first 48 hours post-catheterization ]

3.  Secondary:   Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization).   [ Time Frame: Measured every 12 hours for the first 48 hours post-catheterization ]

4.  Secondary:   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.   [ Time Frame: 12 months post-catheterization ]

5.  Secondary:   Ectopic Tissue Formation.   [ Time Frame: 12 months post-catheterization ]

6.  Secondary:   Number of Deaths   [ Time Frame: 12-months post-catheterization ]

7.  Secondary:   Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test).   [ Time Frame: 12 months post-catheterization ]

8.  Secondary:   Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score.   [ Time Frame: 12 months post-catheterization ]

9.  Secondary:   Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT.   [ Time Frame: 12 Months post-catheterization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: amendizabal@emmes.com


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT00768066     History of Changes
Other Study ID Numbers: 20070443
Study First Received: October 3, 2008
Results First Received: January 17, 2014
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration