Autologous Cell Therapy for Ischemic Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Biological: AMDC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMDC<br> | Biological: AMDC<br>* Cell Treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse events associated with the use of AMDC |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell