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.
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,
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 with active cancer history in the 5 previous years except cured basal cell carcinoma or cured low-stage melanoma,
Patient allergic to local anesthetics
Single group
Adipose tissue derived mesenchymal Stroma/stem Cells transplantation
DrugAllogeneic adipose tissue-derived stromal cells (AdMSC) (CellReady ® drug) will be administered intramuscularly into the ischemic limb (dose of 90x10\^6 AdMSC) of patients. They will be followed at 1 day, 7 days, 30 days, 90 days, and 180 days after the injection.
Evaluation of the tolerance
local and systemic tolerance during 6 months by the collection and analysis of adverse events (serious or non-serious) throughout the duration of the study
Evaluation of the efficacy of the treatment on critical limb ischemia.
Proportion of patients without criteria of CLI
Evaluation of the evolution of ischemia objective parameters.
Pressures, laser-Doppler and TcPO2
Evaluation of the healing.
Number of complete scarring
Evaluation of the proportion of patients who required a major amputation.
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