Autologous transplantation of Adipose tissue derived mesenchymal Stroma/stem Cells (ASC) in patients with critical limb ischemia: a phase II study (ACellDream 2). - ACellDREAM 2

niversity Hospital Toulouse0 个研究点目标入组 43 人开始时间: 2018年10月23日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Patients over 18 years old,
•Rest pain or ischemic ulcers /gangrene of the lower limb, present for at least 15 days, with ankle pressures less or equal than 50 mmHg or toe systolic pressure less than 30 mmHg or TcPO2 less or equal than 35 mmHg,
•Patients who signed the informed consent,
•Patient affiliated to a social security system,
•Patient with persistent CLI after revascularization will be included if :
•1/ they have severe cardiac, respiratory or renal disease who are at increased risk of complication from surgery or anesthesia, e.g. moderately severe or severe heart failure (NYHA class III or IV), severe or very severe Chronic Obstructive Pulmonary disease or severe renal disease (creatinine clearance <30mL/minute).
•2/ there is no option for endovascular or open surgery revascularization ; or poor option (defined by: need for an infra-popliteal by-pass without the availability of autologous great saphenous vein, need for use of great saphenous vein <3mm in diameter for tibial level bypass based on venous duplex ultrasound, or calcified or small (<2 mm) distal target vessel, or open wound on the receiving site or infrapopliteal PAD)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 43
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 43

•History of cancer
•Need of a major amputation (amputation at or above the ankle) within 4 weeks,
•Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
•TcPO2 <10mmHg at rest and < 30mmHg sitting with legs dependent (very poor vascular reserve),
•Positive HIV-1 or 2, HTLV-1 or 2, HBV (except vaccine profile), Syphilis (except inactive disease), or HCV,
•Patients necessitating drugs with inhibitory or stimulatory effect on the growth and multiplication of cells or drugs with immunosuppressive effect: Cyclosporine, Mycophenolate mofetil, Azathioprine, Tacrolimus (systemic), Anthracyclines, Neupogene or equivalent, Etanercept, Interferons, Corticoids at anti-inflammatory doses,
•No possibility of adipose tissue harvest and cell injection in the leg,
•Another clinical trial participation (except non interventional studies),
•Patient under judicial protection,
•Pregnant and breastfeeding women,
•Women of childbearing age without effective contraception,
•Refusal of the patient to participate in the study,
•Lack in understanding the nature and aims of the study and/or difficulties in communication with the investigator.

发起方

niversity Hospital Toulouse