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Mesenchymal Stem Cell Administration in the Treatment of Coronary Graft Disease in Heart Transplant Patients

NCT02472002 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-02-23

No results posted yet for this study

Summary

MES-HT is a pilot multicenter prospective study conducted in transplant patients who developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of bone marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping system.

The main objective is to determine the effect of the administration of autologous mesenchymal cells of the bone marrow by intramyocardial injection on myocardial perfusion in cardiac transplant patients with severe coronary vasculopathy.

Conditions

  • Coronary Disease
  • Heart Transplant

Interventions

BIOLOGICAL

Mesenchymal cell therapy

Name of the experimental cell preparation: Concentrated mesenchymal stem cells (MSCs) derived from autologous bone marrow * Registry Type: autologous * Qualitative and quantitative composition of the finished product: The product is a cell suspension consisting of mesenchymal stem cells (MSC) 40 x 106 MSC / ml suspended in human albumin (ALBUNORM ® 5% OCTAPHARMA France). * Route of administration: endomyocardial injection * Dose administered: 120-140 x106 MSC (mesenchymal stem cells)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Richard Isnard, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02472002 on ClinicalTrials.gov