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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 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.

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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.

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

FieldValue
Enrollment Target 125 participants
Start Date 2015-10
Est. Completion 2020-07-22
Phase Phase 2

What the Registry Record Tells You About NCT02501811

The ClinicalTrials.gov registry entry for NCT02501811 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 366-participant average among 10 other Ischemic Cardiomyopathy trials with a reported enrollment target (66% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.