Adipose tissue derived mesenchymal Stroma/stem Cells transplantation: Allogeneic 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
* Immunosuppressive therapy
* Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
* Patient under the protection of justice or under guardianship or curatorship.
Primary outcome measure(s)
Evaluation of the tolerance — 6 months 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
Trial sites (1)
Facility
City
Region
Status
CHU Toulouse
Toulouse
France
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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