Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)
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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: NCT00684060 |
Recruitment Status :
Completed
First Posted : May 26, 2008
Results First Posted : May 4, 2012
Last Update Posted : July 10, 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 |
Enrollment | 87 |
Participant Flow
Recruitment Details | Enrollment took place at five Network centers and their associated satellite facilities between July 8, 2008 and February 28, 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 |
Arm/Group Title | Stem Cell Arm | Placebo Arm |
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Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI. |
Period Title: Overall Study | ||
Started | 58 | 29 |
Completed | 55 | 26 |
Not Completed | 3 | 3 |
Reason Not Completed | ||
Lost to Follow-up | 1 | 0 |
New stenosis identified | 1 | 0 |
Unable to collect MRI | 1 | 2 |
Death | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Stem Cell Arm | Placebo Arm | Total | |
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Participants will receive active stem cell infusion 2 to 3 weeks after a percutaneous coronary intervention (PCI). | Participants will receive placebo infusion (5% human serum albumin [HSA]) 2 to 3 weeks after a PCI. | Total of all reporting groups | |
Overall Number of Baseline Participants | 58 | 29 | 87 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 58 participants | 29 participants | 87 participants | |
57.6 (11) | 54.6 (11) | 57 (11) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 58 participants | 29 participants | 87 participants | |
Female |
12 20.7%
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3 10.3%
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15 17.2%
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Male |
46 79.3%
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26 89.7%
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72 82.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 58 participants | 29 participants | 87 participants |
58 | 29 | 87 |
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Results Point of Contact
Name/Title: | Lemuel Moye, MD, PhD |
Organization: | UT-Houston School of Public Health |
Phone: | 713-500-9518 |
EMail: | Lemmoye@msn.com |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00684060 |
Other Study ID Numbers: |
578 1U01HL087318 ( U.S. NIH Grant/Contract ) 1 U01-HL-087318-01 (Project 2) |
First Submitted: | May 22, 2008 |
First Posted: | May 26, 2008 |
Results First Submitted: | April 9, 2012 |
Results First Posted: | May 4, 2012 |
Last Update Posted: | July 10, 2015 |