Autologous Cell Therapy for Ischemic Heart Failure

Cook Group

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Ischemic Heart Disease

Treatments: Biological: AMDC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01353690

10-013

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

AMDC

Experimental group

Treatment:

Biological: AMDC