Chronic Myocardial IschemiaPhase 1MESADNCT02460770
Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
A Phase 1 study testing Autologous mesenchymal stem cells in people with Chronic Myocardial Ischemia, run by University Hospital, Toulouse at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Myocardial Ischemia
- What is being tested?
- Autologous mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Cardiology Department of Rangueil Hospital - Rangueil Hospital
Toulouse, 31059
About this study
Official title: Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
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.
Read the 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
- Being tested
- Autologous mesenchymal stem cells
- Keywords
- Left Ventricular Assist Device, stem cell therapy, ischemic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous mesenchymal stem cellsDrug
Also called MSC
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Autologous mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (11)
Ejection Fraction
Global and regional contractile function during echocardiography
Measured: 12 months
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,
Measured: 12 months
Walking distance in 6 minutes
measure of walk distance during six minutes
Measured: 12 months
weaning procedure
progressive reduction of the pump speed
Measured: 12 months
Quality of life
assessment of quality of life by Minnesota Living with Heart Failure Questionnaire
Measured: 12 months
Measure of heart pressures
measure of heart pressures and cardiac output
Measured: 12 months
Brain natriuretic peptide
assessment of variation of brain natriuretic peptide
Measured: 12 months
Troponin
assessment of variation of troponin
Measured: 12 months
Major bleeding
Measured: 1 month
Systemic embolism
Measured: 1 month
Deaths
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015 (estimated)
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Roncalli Jérome, MD, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460770
- Sponsor's protocol ID
- 13 150 03
- Acronym
- MESAD
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Investigation of Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT02460770
- Acronym / sponsor ID
- MESAD / 13 150 03
- Conditions
- Chronic Myocardial Ischemia
- Keywords
- Left Ventricular Assist Device, stem cell therapy, ischemic heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Thoratec Corporation
- Study start
- Jun 2015 (estimated)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous mesenchymal stem cells | Experimental | Drug: Autologous mesenchymal stem cellsAfter 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (15 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous mesenchymal stem cellsAlso: MSCAfter 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. | Drug | autologous mesenchymal stem cells |
Primary outcome
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
11 secondary outcomes
Ejection Fraction
Time frame: 12 months
Maximal Oxygen consumption
Time frame: 12 months
Walking distance in 6 minutes
Time frame: 12 months
weaning procedure
Time frame: 12 months
Quality of life
Time frame: 12 months
Measure of heart pressures
Time frame: 12 months
Brain natriuretic peptide
Time frame: 12 months
Troponin
Time frame: 12 months
Major bleeding
Time frame: 1 month
Systemic embolism
Time frame: 1 month
Deaths
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Myocardial Ischemia
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roncalli Jérome, MD, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous mesenchymal stem cells in people with Chronic Myocardial Ischemia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the full procedure (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.