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:
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
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


  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.
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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 ]

2.  Primary:   Regional Left Ventricular Function (Infarct Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]

3.  Primary:   Regional Left Ventricular Function (Border Zone Wall Motion)   [ Time Frame: Measured at Baseline and Month 6 ]
  Hide Outcome Measure 3

Measure Type Primary
Measure Title Regional Left Ventricular Function (Border Zone Wall Motion)
Measure Description Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.
Time Frame Measured at Baseline and Month 6  
Safety Issue No  

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.

Five patients were excluded from analysis due to incomplete signal intensity enhancement data (1) or lack of a signal intensity enhancement signal in the border zone (4).

Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months.


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.

Measured Values
    Stem Cell Arm     Placebo Arm  
Number of Participants Analyzed  
[units: participants]
  53     23  
Regional Left Ventricular Function (Border Zone Wall Motion)  
[units: mm]
Mean ± Standard Deviation
  0.5  ± 7.2     3.2  ± 6.3  


Statistical Analysis 1 for Regional Left Ventricular Function (Border Zone Wall Motion)
Groups [1] All groups
Method [2] t-test, 2 sided
P Value [3] <0.05
Mean Difference (Net) [4] -2.6
Standard Error of the mean ± 6.9
95% Confidence Interval ( -6.0 to 0.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Combined Endpoint   [ Time Frame: Measured at Baseline and Month 6 ]

5.  Secondary:   Left Ventricular Mass   [ Time Frame: Measured at Baseline and Month 6 ]

6.  Secondary:   End Diastolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

7.  Secondary:   End Systolic Volume Index   [ Time Frame: Measured at Baseline and Month 6 ]

8.  Secondary:   Infarct Volume   [ Time Frame: Measured at Baseline and Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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