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

Chronic Myocardial Ischemia Clinical Trial

— MESAD  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02460770
• Other study ID #: 13 150 03
• Status: Withdrawn
• Phase: Phase 1
• First received: January 22, 2015
• Last updated: January 3, 2018
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Myocardial Ischemia
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
France	Cardiology Department of Rangueil Hospital - Rangueil Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Thoratec Corporation

Country where clinical trial is conducted

France, 

Outcome

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