CD133+ Cell Therapy for Refractory Coronary Heart Disease

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria:

• Patients with proven CHD by coronary angiography demonstrating occlusion or extreme stenosis (> 90%) of a coronary artery (target artery) not suitable for angioplasty or surgery.
• Angiographic criteria: Feasibility for balloon catheter placement without risks of obstruction of the left main coronary trunk.
• Evidence of viable myocardial tissue in the area irrigated by the target artery by MRI (low dose dobutamine and late enhancement).
• CCS class 2-4 angina pectoris (angina pectoris at rest and at light exertion, obvious reduction in the exertion capacity).
• Optimal antianginal pharmacologic therapy (consistent with the current guidelines of ACC (American College of Cardiology), as well as the DGK (Deutsche Gesellschaft für Kardiologie)
• Signed written consent form accepted by the Ethics Committee.
• Effective contraception in women of child-bearing age.

Exclusion Criteria:

• Severe symptomatic heart failure (NYHA class 4).
• Myocardial aneurysm (in the target region) without evidence of viable myocardium.
• Myocardial infarction in the last 4 weeks.
• Symptomatic ventricular tachycardia.
• Known malignancy.
• Known hematological disease.
• Renal insufficiency with creatinine > 2.5 mg/dl.
• Pregnancy.
• Active chronic inflammatory bowel disease or rheumatic disease with high parameters of inflammation (WBCs above 10/nl and increased C-reactive protein). Systemic steroid administration.
• Severe coagulopathy or phenprocoumon type anticoagulation therapy at the time of bone marrow extraction.
• Antiproliferative therapy (chemotherapy, etc.).
• Non accordance with procedures and follow-up studies.
• Contraindications to MRI studies.
• Known hypersensitivity against mouse immunoglobulins.
• Known hypersensitivity against ferridextran.
• Contraindications for bone marrow extraction.
• Cerebrovascular accident in the past four months.