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.
Conditions
Interventions
Product Name: adipose derived stromal cells (ASC)
Pharmaceutical Form: Solution for suspension for injection
Sponsors
University Hospital Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Number of patients alive without amputation and without critical limb ischemia (defined as the presence of rest pain or ischemic ulcer and ankle pressures less or equal than 50 mmHg or toe systolic pressure less than 30 mmHg or TcPO2 less or equal than 35 mmHg), at 6 month.;Timepoint(s) of evaluation of this end point: at 6 month;Main Objective: The main objective of the study is to evaluate the efficacy of the injection of autologous ASC, in term of recovering of critical limb ischemia, in patients with critical limb ischemia of inferior limbs; Secondary Objective: 1. Evaluation of the neo-angiogenesis of the treated limb (Angio IRM), 2. Evaluation of the blood flow and hemodynamic parameters of the limb (Doppler, TCPO2 and pressure), 3. Percentage reduction of wound area (if present), 4. Evaluation of time to complete healing, 5. Evaluation of pain reduction, 6. Evaluation of the product safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Blind evaluation (to patient and sequence) of the number of new vessels in the treated limb by standardized angiographic magnetic resonance. 2. Blood flow velocity evaluated by laser Doppler, transcutaneous pressure of oxygen (TcPO2 (mmHg)), ankle pressure (mmHg). 3. Percentage reduction of wound surface (standardized layer measurement) from baseline. 4. Percentage of patients with complete ulcer healing. 5. Pain reduction from baseline evaluated by standardized evaluation (visual scale and drug consumption). 6. Percentage of patients with wound infection (expected adverse events). ;Timepoint(s) of evaluation of this end point: All secondary events will be evaluated at D7, D30, D90, and D180. | — |
Countries
France
Contacts
Public ContactPauze Amandine
University Hospital Toulouse
Outcome results
None listed