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NCT00768066 · ClinicalTrials.gov registry record · Phase 1
The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)
A Phase 1 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00768066 is a Phase 1 study that has completed, run by University of Miami. The registered enrollment target is 65 participants.
The verdict
NCT00768066, a Phase 1 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium; often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial, and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also been studies clinically. Currently, bone marrow or bone marrow-derived cells represent highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials. Chronic ischemic left ventricular dys
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Autologous human mesenchymal cells (hMSCs)
- BIOLOGICAL Autologous human bone marrow cells (hBMCs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00768066
The ClinicalTrials.gov registry entry for NCT00768066 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00768066 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00768066 about?
NCT00768066 is a clinical study titled "The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)". The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to cult...
What is the current status of trial NCT00768066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2008-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00768066?
The interventions under investigation include: Placebo (BIOLOGICAL), Autologous human mesenchymal cells (hMSCs) (BIOLOGICAL), Autologous human bone marrow cells (hBMCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00768066?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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