Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Autologous Cell Therapy for Ischemic Heart Failure

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01353690
First received: May 12, 2011
Last updated: July 28, 2014
Last verified: July 2014
  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 ]

Enrollment: 9
Study Start Date: May 2011
Study Completion Date: June 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353690

Locations
Canada, Alberta
University of Alberta and Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada, T6G 2B7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
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: July 28, 2014
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
Heart Diseases
Heart Failure
Ischemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014