Phase I/II clinical study of angiogenesis by Ex-Vivo Expanded Erythroblast Transplantation (Autologous) (EVEETA) for the treatment of patients with chronic severe limb ischaemia

iigata University Medical and Dental Hospital (Japan)0 个研究点目标入组 20 人开始时间: 2007年12月18日最近更新: 2021年4月26日

适应症

试验速览

•1. Peripheral Arterial Disease (PAD) including Arteriosclerosis Obliterans (ASO), Buerger disease, and arteritis associated with collagen diseases
•2. Fontaines stage: IIb, III, and IV
•3. Chronic limb ischaemia, including rest pain, non-healing ischaemic ulcers, or both, and were not candidates for non-surgical or surgical revascularisation
•4. Age: greater than 20 or less than 80 years
•5. World Health Organization (WHO) performance status: 0 to 3

•1. Patients with the expected rest of their life less than 1 year
•2. Patients with drug dependence during the past 3 months
•3. Patients with malignant evidence of malignant disorder during the past 5 years
•4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy
•5. Patients with significant coronary stenosis
•6. Pregnant or possibly pregnant females
•7. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month
•8. Patients with active infection including Treponema pallidum
•9. Patients with positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
•10. Patients with history of allergy for antibiotics or iodo

发起方

iigata University Medical and Dental Hospital (Japan)