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NCT02501811 · ClinicalTrials.gov registry record · Phase 2
Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
A Phase 2 study of Ischemic Cardiomyopathy, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 125
- Enrollment target
- 7
- Study locations
NCT02501811: Completed Phase 2 study of Ischemic Cardiomyopathy, sponsored by The University of Texas Health Science Center, Houston.
NCT02501811 is a Phase 2 study of Ischemic Cardiomyopathy that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 125 participants, below the 366-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target (66% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02501811, a Phase 2 study of Ischemic Cardiomyopathy, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 125 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.
Primary Outcome
Change in left ventricular ejection fraction as assessed via cardiac MRI
Conditions Studied
Interventions
- BIOLOGICAL Mesenchymal Stem Cells (MSC)
- BIOLOGICAL c-kit+ cells
- BIOLOGICAL Placebo (Plasmalyte A)
Study Locations (7)
Florida
- University of Florida-Department of Medicine - Gainesville
- University of Miami-Interdisciplinary Stem Cell Institute - Miami
California
- Stanford University School of Medicine (Falk Cardiovascular Research Center) - Stanford
Indiana
- Indiana Center for Vascular Biology and Medicine - Indianapolis
Kentucky
- University of Louisville - Louisville
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
Texas
- Texas Heart Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-07-22 |
| Phase | Phase 2 |
What the finished NCT02501811 record still lists
NCT02501811 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 366-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Ischemic Cardiomyopathy appearing as the primary indexed condition, and to 3 interventions - of which Mesenchymal Stem Cells (MSC) is the first listed.
NCT02501811 lists 7 locations in 6 states (Florida, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT02501811 about?
NCT02501811 is a clinical study titled "Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure". This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as ...
What is the current status of trial NCT02501811?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 125 participants. The study started on 2015-10. Estimated completion is 2020-07-22.
What conditions does trial NCT02501811 study?
This clinical trial studies the following conditions: Ischemic Cardiomyopathy.
What interventions are being tested in trial NCT02501811?
The interventions under investigation include: Mesenchymal Stem Cells (MSC) (BIOLOGICAL), c-kit+ cells (BIOLOGICAL), Placebo (Plasmalyte A) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02501811?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02501811 being conducted?
This trial has 7 study locations across California, Florida, Indiana, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02501811's enrollment target sits among peer trials
125 8th of 10 higher than 3 of 10 other Ischemic Cardiomyopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Cardiomyopathy 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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