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

This study has suspended participant recruitment.
(Contamination of the Pitié-Salpêtrière biotherapy laboratory)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02472002
First Posted: June 15, 2015
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention Phase
Coronary Disease Heart Transplant Biological: Mesenchymal cell therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell Administration in the Treatment of Coronary Graft Disease in Heart Transplant Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • myocardial perfusion measured in MRI. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • complications of catheterization [ Time Frame: 6 months ]
  • complications of endomyocardial injection [ Time Frame: 6 months ]
  • systolic function [ Time Frame: 6 months ]
  • diastolic function [ Time Frame: 6 months ]
  • immunomodulation induced MSCs in the blood [ Time Frame: 6 months ]
  • immunomodulation induced MSCs in myocardial biopsy [ Time Frame: 6 months ]

Estimated Enrollment: 14
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal cell therapy 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)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  1. Cardiac transplant patient whatever is his initial pathology
  2. Coronary vasculopathy grade 3 (CAV3) defined by:

    Stenosis > 50% of common-core (CT) or stenosis >70% of at least 2 or 3 main coronary arteries or stenosis > 70% on secondary branches of 3 territories.

    Coronary vasculopathy grade 1 or 2 (CAV 1 or 2) associated with FELV (FEVG) dysfunction <45% or abnormality of completion of restrictive type.

  3. Defect of drip on at least 2 segments/17 in stress MRI.
  4. Fraction of ejection LV<50 measured on ultrasound examination or confusion of diastolic function defined by a restrictive mitral steam (E/A > 2 or E/A between 1 and 2 and deceleration time E < 150 ms) or left ventricular diastolic pressure measured during coronarography >16mg Hg .
  5. Without sign of acute rejection at the time of inclusion.
  6. Under an optimal medical treatment
  7. Patient who have given his enlightened and signed consent

Exclusion criteria :

  1. Patients <18 ou >80 years
  2. Acute coronary syndrome or revascularisation in the 3 last months
  3. Acute cardiac rejection in the 3 last months
  4. Atrial fibrillation
  5. Claustrophobia or contraindication to MRI (ex:pace-maker), to contrast injection or adenosine.
  6. Presence of a thrombus in the left cavities detected by ultra-sound examination or MRI realized before the injection..
  7. Pregnant or breast-feeding woman
  8. Woman old enough to reproduction without effective means of contraception during its participation in the study
  9. Patient benefiting from a legal protective measure
  10. HIV positive
  11. Not membership in a national save insurance (beneficiary or legal successor)
  12. Patients undergoing others biomedical research
  13. Patient not understanding the procedure bound to the protocol
  14. Bad adhesion to the protocol suspected by the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472002


Locations
France
Département de cardiologie du Pr Michel KOMADJA
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Richard Isnard, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02472002     History of Changes
Other Study ID Numbers: P 100102
First Submitted: June 1, 2015
First Posted: June 15, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Transplant coronary diseases
Mesenchymal cell therapy
Administration of CSM by NOGA system
Coronary disease in heart transplant patients

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases