Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The 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:
NCT00684021
First received: May 22, 2008
Last updated: April 2, 2013
Last verified: April 2013
Results First Received: January 18, 2013  
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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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment took place at five Network centers and their associated satellite facilities between July 2008 and November 2011. The main centers are located in Ohio, Texas, Florida, Minnesota, and Tennessee. Study brochures, patient informational DVDs, and clinical trials.gov were among the tools used for recruitment.

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
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.

Participant Flow:   Overall Study
    Day 3 Stem Cell Arm     Day 3 Placebo Arm     Day 7 Stem Cell Arm     Day 7 Placebo Arm  
STARTED     43     24     36     17  
COMPLETED     41     22     34     15  
NOT COMPLETED     2     2     2     2  
MRI Contraindicated                 1                 1                 1                 0  
MRI not performed                 0                 1                 1                 2  
Death                 1                 0                 0                 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.
No text entered.

Reporting Groups
  Description
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.
Total Total of all reporting groups

Baseline Measures
    Day 3 Stem Cell Arm     Day 3 Placebo Arm     Day 7 Stem Cell Arm     Day 7 Placebo Arm     Total  
Number of Participants  
[units: participants]
  43     24     36     17     120  
Age  
[units: years]
Mean ± Standard Deviation
  55.6  ± 10.8     57.0  ± 12.4     58.2  ± 11.3     57.0  ± 8.0     56.9  ± 10.9  
Gender  
[units: participants]
         
Female     5     3     5     2     15  
Male     38     21     31     15     105  
Region of Enrollment  
[units: participants]
         
United States     43     24     36     17     120  



  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 ]

4.  Secondary:   Clincal and Safety Outcomes   [ Time Frame: Measured from baseline to six months. ]

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 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title End Systolic Volume Index
Measure Description Left ventricular end systolic volume index. Values reported represent the change in LV end systolic volume index 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.

Only participants with both baseline and 6 month MRI images available are included.

Values reported represent the change in LV end systolic volume index from baseline to six months.


Reporting Groups
  Description
Day 3 Stem Cell Arm Participants will receive active adult stem cell infusion 3 days after percutaneous coronary intervention (PCI).
Day 3 Placebo Arm Participants will receive placebo infusion (5% human serum albumin [HSA]) 3 days after PCI.
Day 7 Stem Cell Arm Participants will receive active adult stem cell infusion 7 days after PCI.
Day 7 Placebo Arm Participants will receive placebo infusion (5% HSA) 7 days after PCI.

Measured Values
    Day 3 Stem Cell Arm     Day 3 Placebo Arm     Day 7 Stem Cell Arm     Day 7 Placebo Arm  
Number of Participants Analyzed  
[units: participants]
  41     22     34     15  
End Systolic Volume Index  
[units: mL/m2]
Mean ± Standard Deviation
  4.1  ± 15.0     4.1  ± 16.5     6.2  ± 17.4     4.6  ± 12.8  


Statistical Analysis 1 for End Systolic Volume Index
Groups [1] All groups
Method [2] Regression, Linear
P Value [3] 0.817
Mean Difference (Net) [4] 0.7
Standard Error of the mean ± 3.7
95% Confidence Interval ( -5.5 to 7.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.
[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.



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


  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
The choice of Day 3 or Day 7 as randomization points while based on the literature were nevertheless somewhat arbitrary. cMR-baseed ejection fractions tended to be high.


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