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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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  More Information
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