Tolerance Study of Allogeneic of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (AdMSC) Transplantation in Patients With Critical Limb Ischemia.
Key facts
- Where
- Toulouse, FranceSee the site
- Phase
- Phase 1
Where in France
- CHU ToulouseToulouse, FranceContact: François Xavier LAPEBIE, MDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT06795620EU 2023-509312-29-00
- Record updated
- 28 January 2025
- Original description
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.Read full original descriptionShow less
Critical limb ischemia (CLI) is the most severe stage of peripheral arterial disease (PAD). Cell therapy delivered to the ischemic muscle constitutes a promising approach to treat CLI patients with no or poor options of vascularization. Pre-clinical study and clinical phase I have demonstrated the safety and feasibility of the use of autologous AdMSC treatment in patients without option for revascularization CLI patients and encouraging preliminary efficacy results have been highlighted in the pilot phase. In order to optimize AdMSC quality and to accelerate treatment availability researchers decide to test the use of allogeneic cryopreserved AdMSC from healthy donor. The aim of this phase I study is to evaluate the safety of allogeneic AdMSC injection in ischemic leg.
Inclusion: Patients over 18 years old,; Patients with CLI according international definition: 1) rest pain of ischemic origin or ischemic trophic disorder present for at least 15 days, and 2) an ankle pressure ≤50 mmHg (≤70 mmHg for diabetic patients) or a toe pressure ≤30 mmHg or a TcPO2 ≤30 mmHg,; Patient not revascularizable by decision of the surgeon or anesthesiologist orpatient with persistent critical ischemia after revascularization,; Patient with a life expectancy greater than 6 months,; Patients who signed the informed consent,; Women of childbearing age with effective contraception (oral contraception, IUD, dermal implant) and with negative pregnancy test,; Patient affiliated to a social security system.
Exclusion: Patient with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,; Immunosuppressive therapy; Patient allergic to local anesthetics; Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,; Need of a major amputation (amputation at or above the ankle) within 1 month following the inclusion,; Another clinical trial participation (except observational studies),; Patient under the protection of justice or under guardianship or curatorship.