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Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00684060
First received: May 22, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
Results First Received: April 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Left Ventricular Dysfunction
Interventions: Biological: Adult stem cells
Biological: Placebo

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.
Total Total of all reporting groups

Baseline Measures
    Stem Cell Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
 		  58     29     87  
Age  
[units: years]
Mean ± Standard Deviation 		  57.6  ± 11     54.6  ± 11     57  ± 11  
Gender  
[units: participants]
 		     
Female     12     3     15  
Male     46     26     72  
Region of Enrollment  
[units: participants]
 		     
United States     58     29     87  



  Outcome Measures
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1.  Primary:   Global Left Ventricular Function   [ Time Frame: Measured at Baseline and Month 6 ]
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2.  Primary:   Regional Left Ventricular Function (Infarct Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]
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3.  Primary:   Regional Left Ventricular Function (Border Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]
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4.  Secondary:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]
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5.  Secondary:   Left Ventricular Mass   [ Time Frame: Measured at Baseline and Month 6 ]
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6.  Secondary:   End Diastolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]
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7.  Secondary:   End Systolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]
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8.  Secondary:   Infarct Volume   [ Time Frame: Measured at Baseline and Month 6 ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame Events reported are from Randomization Date to the 6 month endpoint data collection window (i.e. 210 days post intervention)
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Stem Cell Arm Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI).
Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI.

Other Adverse Events
    Stem Cell Arm     Placebo Arm  
Total, other (not including serious) adverse events      
# participants affected / at risk     13/58     14/29  
Blood and lymphatic system disorders      
Anemia †    
# participants affected / at risk     4/58 (6.90%)     2/29 (6.90%)  
# events     4     2  
Cardiac disorders      
Chest Pain †    
# participants affected / at risk     4/58 (6.90%)     4/29 (13.79%)  
# events     5     4  
Tachycardia †    
# participants affected / at risk     0/58 (0.00%)     3/29 (10.34%)  
# events     0     3  
Syncope †    
# participants affected / at risk     1/58 (1.72%)     2/29 (6.90%)  
# events     1     2  
Gastrointestinal disorders      
Nausea †    
# participants affected / at risk     3/58 (5.17%)     0/29 (0.00%)  
# events     3     0  
Respiratory, thoracic and mediastinal disorders      
Bronchitis †    
# participants affected / at risk     1/58 (1.72%)     3/29 (10.34%)  
# events     1     3  
† Events were collected by systematic assessment



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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Lack of in-vivo testing of cell product. While there are several different approaches to measure myocardial strain (myocardial tagging, DENSE, etc.), these were not employed in this study due to the need for specialized expertise at each site.  


Results Point of Contact:  
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
phone: 713-500-9518
e-mail: Lemmoye@msn.com


Publications of Results:

Other Publications:


Responsible Party: Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00684060     History of Changes
Other Study ID Numbers: 578, 1U01HL087318, 1 U01-HL-087318-01 (Project 2)
Study First Received: May 22, 2008
Results First Received: April 9, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration