Adipose Cell Derived Regenerative Endothelial and Angiogenic Medicine

Phase 1

• Conditions: Patients with rest pain or ischemic ulcers/gangrene of the lower limb and without option for revascularization or poor option. Or patients with with rest pain or ischemic ulcers and persistent CLI after revascularization, or with severe cardiac, respiratory or renal disease who are at increased risk of complication from surgery or anesthesia, or with moderately severe or severe heart failure, severe or very severe Chronic Obstructive Pulmonary disease or severe renal disease.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-000967-10-FR
• Lead Sponsor: niversity Hospital Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 43

Inclusion Criteria

•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).
OR
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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified