NCT01353690TerminatedPhase 1
A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
Cook MyoSite4 sites in 1 country9 target enrollmentStarted: February 5, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 9
- Locations
- 4
- Primary Endpoint
- Incidence of major adverse events associated with the use of AMDC
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of major adverse events associated with the use of AMDC
Time Frame: 12 Months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
Loading locations...
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