Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
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ClinicalTrials.gov Identifier: NCT00684021 |
Recruitment Status
:
Completed
First Posted
: May 26, 2008
Results First Posted
: April 4, 2013
Last Update Posted
: June 30, 2015
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Sponsor:
The University of Texas Health Science Center, Houston
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
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Study Type: | Interventional |
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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 |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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 |
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No text entered. |
Reporting Groups
Description | |
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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 | |
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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 |

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

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 |
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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. |