Ischemic Heart Disease
Conditions
Keywords
Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell
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.
Interventions
BIOLOGICALAMDC
Cell Treatment
Sponsors
Cook MyoSite
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse events associated with the use of AMDC | 12 Months |
Countries
Canada
Outcome results
None listed