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NCT01087996 · ClinicalTrials.gov registry record · Phase 1
The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)
A Phase 1 study of Stem Cell Transplantation, sponsored by University of Miami.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01087996: Completed Phase 1 study of Stem Cell Transplantation, sponsored by University of Miami.
NCT01087996 is a Phase 1 study of Stem Cell Transplantation that has completed, run by University of Miami. The registered enrollment target is 31 participants, below the 41-participant average among 8 other Stem Cell Transplantation trials with a reported enrollment target (24% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087996, a Phase 1 study of Stem Cell Transplantation, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
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 studied 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
Conditions Studied
Interventions
- BIOLOGICAL Auto-hMSCs
- BIOLOGICAL Allo-hMSCs
Study Locations (2)
Florida
- University of Miami Miller School of Medicine - Miami
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT01087996 record still lists
NCT01087996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 41-participant average among 8 other Stem Cell Transplantation trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Stem Cell Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Auto-hMSCs is the first listed.
NCT01087996 reports a single indexed study location in Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT01087996 about?
NCT01087996 is a clinical study titled "The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)". 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 NCT01087996?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-03. Estimated completion is 2012-10.
What conditions does trial NCT01087996 study?
This clinical trial studies the following conditions: Stem Cell Transplantation.
What interventions are being tested in trial NCT01087996?
The interventions under investigation include: Auto-hMSCs (BIOLOGICAL), Allo-hMSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT01087996?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01087996 being conducted?
This trial has 2 study locations across Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01087996's enrollment target sits among peer trials
31 5th of 8 higher than 4 of 8 other Stem Cell Transplantation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stem Cell Transplantation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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