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NCT01392625 · ClinicalTrials.gov registry record · Phase 1
PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study)
A Phase 1 study, sponsored by Joshua M Hare.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01392625 is a Phase 1 study that has completed, run by Joshua M Hare. The registered enrollment target is 37 participants.
The verdict
NCT01392625, a Phase 1 study, has completed, sponsored by Joshua M Hare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium2-4. 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 cardiomyocytes5, embryonic stem cell-derived myocytes6, 7, tissue engineered contractile grafts8, skeletal myoblasts9, several cell types derived from adult bone marrow10-15, and cardiac precursors residing within the heart itself16. 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. Non-ischemic dilated
Interventions
- BIOLOGICAL Allogeneic hMSCs
- BIOLOGICAL Autologous hMSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-05-19 |
| Est. Completion | 2017-08-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01392625
The ClinicalTrials.gov registry entry for NCT01392625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joshua M Hare, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Allogeneic hMSCs is the first listed.
NCT01392625 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01392625 about?
NCT01392625 is a clinical study titled "PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study)". The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty1, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium2-4. Ideally, graft cells should be readily available, easy to ...
What is the current status of trial NCT01392625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2011-05-19. Estimated completion is 2017-08-28.
What interventions are being tested in trial NCT01392625?
The interventions under investigation include: Allogeneic hMSCs (BIOLOGICAL), Autologous hMSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT01392625?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
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