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Combination of Mesenchymal and C-kit+ Cardiac Stem Cells as Regenerative Therapy for Heart Failure
NCT02501811 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02501811
The ClinicalTrials.gov registry entry for NCT02501811 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 811 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02501811 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02501811?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 811 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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