Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device

Phase 1

Withdrawn

• Conditions: Chronic Myocardial Ischemia
• Interventions: Drug: Autologous mesenchymal stem cells

• Registration Number: NCT02460770
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy and Left Ventricular Assist Device program is to improve heart function with stem cell therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.

Detailed Description

Currently Left Ventricular Assist Device-only patients are being implanted and followed. Feasibility of autologous mesenchymal stem cell grafting in patients receiving heart mate will be assessed in a 4 patient pilot trial. Mesenchymal stem cell are delivered during Left Ventricular Assist Device surgery by intramyocardial infusions. Recovery of contractile function of the heart is assessed during attempts to wean patients from Left Ventricular Assist Device

Study Timeline

• Study First Submitted: 2015-01-22
• Study First Submitted QC: 2015-05-29
• Study Start: 2015-06
• Study First Posted: 2015-06-02
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous mesenchymal stem cells	Autologous mesenchymal stem cells	After bone-marrow aspiration by an authorized person, Mesenchymal Stem Cells were isolated and cultured during 17 days by the French Blood Establishment. Then, patients receive intramyocardial injections of Mesenchymal Stem Cells during Left Ventricular Assist Device surgery

Primary Outcome Measures

Name	Time	Method
Feasibility of the full procedure	1 month	ability to perform bone marrow aspiration, cell culture and intramyocardial injections during left Ventricular Assist Device surgery Realization of a full injection procedure

Secondary Outcome Measures

Name	Time	Method
Ejection Fraction	12 months	Global and regional contractile function during echocardiography
Measure of heart pressures	12 months	measure of heart pressures and cardiac output
Brain natriuretic peptide	12 months	assessment of variation of brain natriuretic peptide
Walking distance in 6 minutes	12 months	measure of walk distance during six minutes
weaning procedure	12 months	progressive reduction of the pump speed
Troponin	12 months	assessment of variation of troponin
Deaths	1 month
Maximal Oxygen consumption	12 months	Maximum rate of oxygen consumption as measured during incremental exercise, modification of the body mass (muscular lean mass, muscular strength), duration of the test and load,
Quality of life	12 months	assessment of quality of life by Minnesota Living with Heart Failure Questionnaire
Systemic embolism	1 month
Major bleeding	1 month

Trial Locations

Locations (1)

Cardiology Department of Rangueil Hospital - Rangueil Hospital; 🇫🇷 Toulouse, France