Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Overview
- Phase
- Phase 1
- Intervention
- Autologous mesenchymal stem cells
- Conditions
- Chronic Myocardial Ischemia
- Sponsor
- University Hospital, Toulouse
- Locations
- 1
- Primary Endpoint
- Feasibility of the full procedure
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Autologous mesenchymal stem cells
Outcomes
Primary Outcomes
Feasibility of the full procedure
Time Frame: 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 Outcomes
- Ejection Fraction(12 months)
- Measure of heart pressures(12 months)
- Brain natriuretic peptide(12 months)
- Walking distance in 6 minutes(12 months)
- weaning procedure(12 months)
- Troponin(12 months)
- Deaths(1 month)
- Maximal Oxygen consumption(12 months)
- Quality of life(12 months)
- Systemic embolism(1 month)
- Major bleeding(1 month)