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Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684021
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : April 4, 2013
Last Update Posted : June 30, 2015
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Left Ventricular Dysfunction
Interventions: Biological: Adult stem cells
Biological: Placebo

  Participant Flow

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


  Outcome Measures

1.  Primary:   Global Left Ventricular Function   [ Time Frame: Measured at Baseline and Month 6 ]
  Show Outcome Measure 1

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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
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.


  More Information