Mesenchymal Stem Cells and Myocardial Ischemia

NCT01076920 | Completed Phase 1 DMC

• 1 other identifier: 0505008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Myocardial Ischemia; Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

  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

  30 days to 2 years

Study Arms (1)

Intervention arm

EXPERIMENTAL

Genetic: Mesenchymal stem cells

Interventions

Mesenchymal stem cells GENETIC

60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• French Blood Establishment: collaborator
• Nantes University Hospital: collaborator
• Ministry of Health, France: collaborator

Study Sites (1)

University Hospital (Rangueil)

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 26901787 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• jerome RONCALLI, MD, PhD

  University Hospital Of TOULOUSE

  PRINCIPAL INVESTIGATOR

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: February 10, 2010
• First Posted: February 26, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

FR (1)