NCT02460770

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 22, 2015

Last Update Submit

January 3, 2018

Conditions

Chronic Myocardial Ischemia

Keywords

Left Ventricular Assist Devicestem cell therapyischemic heart failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Ejection Fraction

    12 months

  • Maximal Oxygen consumption

    12 months

  • Walking distance in 6 minutes

    12 months

  • weaning procedure

    12 months

  • Quality of life

    12 months

  • +6 more secondary outcomes

Study Arms (1)

autologous mesenchymal stem cells

EXPERIMENTAL

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

Interventions

Autologous mesenchymal stem cellsDRUG

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.

Also known as: MSC
autologous mesenchymal stem cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department of Rangueil Hospital - Rangueil Hospital

Toulouse, 31059, France

Location

Study Officials

  • Roncalli Jérome, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2015

First Posted

June 2, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

FR(1)