Clinical trial NCT02460770: Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Official title: Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Chronic Myocardial Ischemia
Keywords: Left Ventricular Assist Device
stem cell therapy
ischemic heart failure
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Thoratec Corporation
First posted: 2015-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Feasibility of the full procedure
timeFrame: 1 month
Secondary outcomes:
measure: Ejection Fraction
timeFrame: 12 months
measure: Maximal Oxygen consumption
timeFrame: 12 months
measure: Walking distance in 6 minutes
timeFrame: 12 months
measure: weaning procedure
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Measure of heart pressures
timeFrame: 12 months
measure: Brain natriuretic peptide
timeFrame: 12 months
measure: Troponin
timeFrame: 12 months
measure: Major bleeding
timeFrame: 1 month
measure: Systemic embolism
timeFrame: 1 month
measure: Deaths
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Cardiology Department of Rangueil Hospital - Rangueil Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Roncalli Jérome, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: