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

NCT ID: NCT02460770

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-06-30

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

Conditions

Chronic Myocardial Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Autologous mesenchymal stem cells

Intervention Type: DRUG

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.

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 device surgery.

Intervention Type: DRUG

Other Intervention Names

MSC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thoratec Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roncalli Jérome, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Cardiology Department of Rangueil Hospital - Rangueil Hospital

Toulouse, , France

Countries

France

Other Identifiers

13 150 03

Identifier Type: -

Identifier Source: org_study_id