Autologous Cell Therapy for Ischemic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01353690
Recruitment Status : Terminated
First Posted : May 16, 2011
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook MyoSite )

May 12, 2011
May 16, 2011
July 29, 2014
May 2011
June 2014   (Final data collection date for primary outcome measure)
Incidence of major adverse events associated with the use of AMDC [ Time Frame: 12 Months ]
Same as current
Complete list of historical versions of study NCT01353690 on Archive Site
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Autologous Cell Therapy for Ischemic Heart Failure
A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
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.
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Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ischemic Heart Disease
Biological: AMDC
Cell Treatment
Experimental: AMDC
Intervention: Biological: AMDC
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Cook Group Incorporated ( Cook MyoSite )
Cook MyoSite
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Principal Investigator: Hung Q. Ly, MD Montreal Heart Institute
Cook Group Incorporated
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP