Autologous adipose tissue-derived stromal vascular fraction cells for Diabetic foot ulcer

Inclusion criteria

• {"criterion_text":"- Informed Consent Form Information and Signature\n- UPD grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification. University of Texas Appendix 1\n- Neuropathy confirmed by loss of protective sensation on monofilament test (Semmes-Weinstein 5.07 monofilament).\n- UPD located on a toe or on the foot\n- UPD with a surface area of between 1 and 15 cm2 after debridement\n- UPD refractory to conventional treatment for at least 2 months, including an appropriate wound care protocol.\n- No clinical signs of local wound infection (whether target UPD or not) localized to the lower limbs (as defined by IDSA/IWGDF infection criteria).\n- Female or male patient 18 years of age or older\n- Type 1 or 2 diabetes mellitus patient with 10% HbA1C less than 1 month old (if this result is not available at the inclusion visit, analysis should be done during the 15-day assessment period)\n- Affiliation to social security.\n- Patient willing to wear the discharge system daily and the prescribed dressing throughout the study.\n- Patient with BMI 18.5 Kg/m² (in order to have sufficient fat tissue)\n- Good overall condition, based on history and clinical examination\n- Women of childbearing age must have a negative pregnancy test (serum or urine) pregnancy test (detection threshold (sensitivity): 25 mIU hCG/ml). Patients of both sexes must use a reliable method of contraception in accordance with CTFG. In addition, contraception must be maintained throughout the treatment until the end of systemic exposure.\n- UPD with \"satisfactory\" arterial blood supply to the lower limb bearing the target lesion: ischemia grade 0, 1 and 2 according to WIfI classification (Mills JL Sr, 2014)."}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding women or women of childbearing age without effective contraception\n- Patient with serious pathology that could lead to premature discontinuation of the study.\n- Patients with a history of coagulation disorders contraindicating surgical intervention\n- Positive markers of the following active infectious diseases: Infection with immunodeficiency viruses HIV 1 and HIV 2; HTLV I infection; Hepatitis C virus infection Hepatitis B virus infection; Hepatitis C virus infection; Syphilis infection.\n- Congenital or acquired immune deficiency.\n- UPD with ischemia grade 3 according to WIfI classification (Mills JL Sr, 2014)\n- UPD with surgery or revascularization planned at any time during the time of the study\n- deep UPD defined as stage III by the University of Texas Diabetic Wound Classification (Appendix 1)\n- UPD clinically infected, as defined by IDSA/IWGDF infection criteria\n- UPD whose surface is covered by more than 20% black necrosis after debridement\n- UPD located on the scar of the amputation stump\n- Known hypersensitivity to human albumin.\n- UPD with carcinomatous degeneration\n- Reduction ≥ 30% of wound surface measured after the 15 days (Urgostart and adapted offloading system) compared with wound surface area measured at the inclusion visit (on the basis of wound surface measurement) [criterion assessed after the 15-day evaluation period, on the day of treatment].\n- Adults protected by law (under guardianship or curatorship)\n- Minors\n- People staying in a health or social care establishment\n- People in emergency situations\n- Persons not covered by a social security scheme\n- Adults deprived of their freedom by administrative or judicial decision, or subject to a legal protection measure, or who are unable to express their consent\n- Patient participating in another clinical trial\n- Absence or refusal of informed consent\n- Surgical revascularization or surgery of the lower limbs within the last month\n- Ischemic event (stroke, myocardial infarction) within 3 months of inclusion\n- Patient with renal failure requiring dialysis\n- Systemic infection not controlled by appropriate antibiotic treatment\n- Patient with documented osteomyelitis\n- Patient with active neoplasia, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressive therapy.\n- Patient treated for a chronic pathology requiring high-dose corticosteroid therapy (≥ 40 mg/d prednisolone or equivalent)."}

Primary endpoints

• {"endpoint_text":"- percentage (%) of wounds completely healed by week 20 (S20) post-injection","definition_or_measurement_approach":"Complete wound healing assessed at week 20 post-injection; reported as the percentage of wounds completely healed by week 20 (S20) post-injection."}

France

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

13-09-2024

Processing Time Days

7

Number Of Sites

3

Number Of Participants

45

Primary sponsor

Full Name

Centre Hospitalier Regional De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France