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

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ClinicalTrials.gov Identifier: NCT02460770
Recruitment Status : Withdrawn
First Posted : June 2, 2015
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Chronic Myocardial Ischemia Drug: Autologous mesenchymal stem cells Phase 1

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
Estimated Study Start Date : June 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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 Name: MSC




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Ejection Fraction [ Time Frame: 12 months ]
    Global and regional contractile function during echocardiography

  2. Maximal Oxygen consumption [ Time Frame: 12 months ]
    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,

  3. Walking distance in 6 minutes [ Time Frame: 12 months ]
    measure of walk distance during six minutes

  4. weaning procedure [ Time Frame: 12 months ]
    progressive reduction of the pump speed

  5. Quality of life [ Time Frame: 12 months ]
    assessment of quality of life by Minnesota Living with Heart Failure Questionnaire

  6. Measure of heart pressures [ Time Frame: 12 months ]
    measure of heart pressures and cardiac output

  7. Brain natriuretic peptide [ Time Frame: 12 months ]
    assessment of variation of brain natriuretic peptide

  8. Troponin [ Time Frame: 12 months ]
    assessment of variation of troponin

  9. Major bleeding [ Time Frame: 1 month ]
  10. Systemic embolism [ Time Frame: 1 month ]
  11. Deaths [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460770


Locations
France
Cardiology Department of Rangueil Hospital - Rangueil Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Thoratec Corporation
Investigators
Principal Investigator: Roncalli Jérome, MD, PhD Toulouse University Hospital

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02460770     History of Changes
Other Study ID Numbers: 13 150 03
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
Left Ventricular Assist Device
stem cell therapy
ischemic heart failure

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases