Chronic Myocardial IschemiaPhase 1/2MESAMINCT01076920
Mesenchymal Stem Cells and Myocardial Ischemia
A Phase 1/2 study testing Mesenchymal stem cells in people with Chronic Myocardial Ischemia and Left Ventricular Dysfunction, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myocardial Ischemia, Left Ventricular Dysfunction
- What is being tested?
- Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Sep 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75
- Male or female
- NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with)
- Chronic coronary artery disease with left ventricular function below 35%
- Stable medical therapy for at least one month
- Reversible perfusion defects by SPECT
- Not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
- Implantable Cardiovertor Defibrillator
Who cannot join
- Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months
- Sustained ventricular
- Further revascularization planned for the next 30 days.
- Chronic atrial fibrillation.
- A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping).
- An LV thrombus.
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- Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
- Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
- Human immunodeficiency virus (HIV1-2), HTLV-1 and 2.
- An active uncontrolled infection.
- A prosthetic aortic valve.
- A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
- Pregnancy or breastfeeding.
- Active participation in other research therapy for cardiovascular repair/regeneration.
- Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
- Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy
Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.
Read the detailed description
Mesenchymal stem cells from the bone marrow can differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I safety study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.10 patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 24 months follow-up.
- Being tested
- Mesenchymal stem cells
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsGenetic
60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Genetic: Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction
Measured: 30 days
Secondary outcomes (1)
Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function
Measured: 30 days to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionFeb 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- French Blood Establishment, Nantes University Hospital, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- jerome RONCALLI, MD, PhD, Principal investigator, University Hospital Of TOULOUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076920
- Sponsor's protocol ID
- 0505008
- Acronym
- MESAMI
- Status last verified
- Sep 2014
- First submitted
- 10 Feb 2010
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guijarro D, Lebrin M, Lairez O, Bourin P, Piriou N, Pozzo J, Lande G, Berry M, Le Tourneau T, Cussac D, Sensebe L, Gross F, Lamirault G, Huynh A, Manrique A, Ruidavet JB, Elbaz M, Trochu JN, Parini A, Kramer S, Galinier M, Lemarchand P, Roncalli J. Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial. Int J Cardiol. 2016 Apr 15;209:258-65. doi: 10.1016/j.ijcard.2016.02.016. Epub 2016 Feb 2.
PubMed 26901787
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT01076920
- Acronym / sponsor ID
- MESAMI / 0505008
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- French Blood Establishment, Nantes University Hospital, Ministry of Health, France
- Study start
- Oct 2009
- Primary completion
- Feb 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Feb 2010 (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.
Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.
Detailed description
Mesenchymal stem cells from the bone marrow can differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue. The aim of the study is in a phase I safety study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.10 patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 24 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Genetic: Mesenchymal stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75
- Male or female
- NYHA (Heart failure) Class II-IV or Angina pectoris CCS Class III or IV or symptoms consistent with)
- Chronic coronary artery disease with left ventricular function below 35%
- Stable medical therapy for at least one month
Key exclusion criteria (16 listed)
- Acute coronary syndrome, revascularization (PCI or CABG), or cardiac resynchronization during the last 3 months
- Sustained ventricular
- Further revascularization planned for the next 30 days.
- Chronic atrial fibrillation.
- A wall thickness in the target region <8 mm as determined by 2D echocardiography (the target region is defined at the time of NOGA® mapping).
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 |
|---|---|---|
| Mesenchymal stem cells60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16) | Genetic | Intervention arm |
Primary outcome
Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction
Time frame: 30 days
1 secondary outcome
Change from baseline in SF-36, VO2max, 6 min walk test, and the NYHA, CCS Classifications Effect related to cardiac function
Time frame: 30 days to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
- Derived from this study: PubMed 26901787Guijarro D, Lebrin M, Lairez O, Bourin P, Piriou N, Pozzo J, Lande G, Berry M, Le Tourneau T, Cussac D, Sensebe L, Gross F, Lamirault G, Huynh A, Manrique A, Ruidavet JB, Elbaz M, Trochu JN, Parini A, Kramer S, Galinier M, Lemarchand P, Roncalli J. Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial. Int J Cardiol. 2016 Apr 15;209:258-65. doi: 10.1016/j.ijcard.2016.02.016. Epub 2016 Feb 2.
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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.
jerome RONCALLI, MD, PhD principal investigator
University Hospital Of TOULOUSE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cells in people with Chronic Myocardial Ischemia and Left Ventricular Dysfunction, 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 19 Sep 2014. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate safety and feasibility of transendocardial injection using the NogaStar XP Mapping Catheter with the MyostarTM Left Ventricular Injection Catheter of autologous MSC in subjects with chronic myocardial ischemia and left ventricular dysfunction (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01076920, which also lists 1 linked publication.
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 19 Sep 2014.