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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Myocardial Ischemia
• Intervention / Treatment: Drug: Autologous mesenchymal stem cells

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Cardiology Department of Rangueil Hospital - Rangueil Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA:

• Postmenopausal female or female who may become pregnant but is using adequate contraceptive precautions with negative pregnancy test,
• Severe Left Ventricular dysfunction with Ejection Fraction < 30% with ischemic cardiomyopathy,
• New York Heart Association Class III or IV,
• No revascularization options available,
• Listed or not for cardiac transplantation,
• Clinical indication and accepted candidate for Left Ventricular Assistance Device implantation as a destination therapy or as a bridge to transplantation,
• Optimal medical therapy.

EXCLUSION CRITERIA:

• Cardiothoracic surgery within 30 days prior to study entry,
• Myocardial infarction within 3 months prior to study entry,
• Prior cardiac transplantation,
• Left Ventricular reduction surgery or cardiomyoplasty,
• Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism),
• Left ventricular aneurysm or wall thickness preventing cell injections,
• Anticipated requirement for biventricular mechanical support,
• Stroke within 30 days prior to study entry,
• Received investigational intervention within 30 days of study entry,
• Pregnant or breastfeeding at time of study entry,
• Human Imune deficiency Virus, Human T-cell Lymphotrophic Virus, Hepatitis B Virus and Hepatitis C Virus positive within 30 days prior to study entry,
• Active systemic infection within 48 hours prior to study entry,
• History of cancer in the last 5 years,
• Patient participant to other research,
• Patient under treatment that may exert an inhibitory or stimulatory effect on the growth and multiplication of cells, or with immunosuppressive properties.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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 device surgery.; Other Names: MSC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection Fraction	Global and regional contractile function during echocardiography	12 months
Maximal Oxygen consumption	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,	12 months
Walking distance in 6 minutes	measure of walk distance during six minutes	12 months
weaning procedure	progressive reduction of the pump speed	12 months
Quality of life	assessment of quality of life by Minnesota Living with Heart Failure Questionnaire	12 months
Measure of heart pressures	measure of heart pressures and cardiac output	12 months
Brain natriuretic peptide	assessment of variation of brain natriuretic peptide	12 months
Troponin	assessment of variation of troponin	12 months
Major bleeding		1 month
Systemic embolism		1 month
Deaths		1 month

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Thoratec Corporation
• Investigators: Principal Investigator: Roncalli Jérome, MD, PhD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Left Ventricular Assist Device; stem cell therapy; ischemic heart failure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 13 150 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED