Autologous Cell Therapy for Ischemic Heart Failure

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01353690
First received: May 12, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.


Condition Intervention Phase
Ischemic Heart Disease
Biological: AMDC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Incidence of major adverse events associated with the use of AMDC [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMDC Biological: AMDC
Cell Treatment

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18 but less than 80 years
  • Prior myocardial infarction
  • Depressed left ventricular ejection fraction (LVEF) ≤ 35%
  • NYHA functional classification of II to IV

Exclusion Criteria:

  • Not under stable optimal medical management
  • Cardiac surgery or percutaneous coronary intervention within 3 months
  • Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
  • Prior cell, gene, or transmyocardial laser revascularization therapy
  • Ventricular wall thickness in target region ≤ 5 mm
  • Moderate to severe aortic valve stenosis or mechanical valve replacement
  • Left ventricular aneurysm or thrombus
  • Left ventricular dysfunction associated with a reversible cause
  • Vascular disease preventing percutaneous vascular access
  • History of myopathic disease
  • History of neoplasia within 5 years, except for basal cell carcinoma
  • Receiving or planning to receive anti-cancer medications
  • Serum creatinine > 3.0 mg/dl
  • Pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months
  • Life expectancy of less than 1 year
  • Morbid obesity (defined as BMI > 35)
  • History of bleeding diathesis or coagulopathy
  • Positive for HIV, Hepatitis B, or Hepatitis C
  • Known hypersensitivity or contraindication to study product or treatment procedure
  • Enrolled in another research project at the time of enrollment
  • Unable to provide informed consent
  • Unable or unwilling to commit to the follow-up clinical procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353690

Contacts
Contact: Chris Ballas 765-463-7537 cballas@medinst.com

Locations
Canada, Alberta
University of Alberta and Mazankowski Alberta Heart Institute Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Robert Welsh, MD     780-407-3613        
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Nathalie St-Jean, RN     514-376-3330     nathalie.st-jean@icm-mhi.org    
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Hung Q. Ly, MD Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier: NCT01353690     History of Changes
Other Study ID Numbers: 10-013
Study First Received: May 12, 2011
Last Updated: March 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Cook:
Cell Therapy
Heart Failure
Heart Disease
Myocardial Infarction
Myocardial Ischemia
Autologous
Muscle-derived Cell

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

ClinicalTrials.gov processed this record on May 19, 2013