A Phase 1 interventional study of Adipose tissue derived mesenchymal Stroma/stem Cells transplantation in Critical Limb Ischemia, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by University Hospital, Toulouse · Phase 1, Interventional, and Treatment
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.
Lower limbs arteries are a frequent localization of atheroma in elderly people (15-20% after 70 years). The most severe stage of the disease, critical limb ischemia (CLI), defined clinically by the presence of rest pain or ischemic ulcer with an ankle pressure \<50 mmHg or a toe pressure \<30 mmHg or a TcPO2 \<30 mmHg, has a dramatic prognosis at 12 months, with 30% of the patients alive with an amputation, 20% mortality and only 20% of patients with a resolved disease, independently from the treatment. The only validated treatment for this disease is revascularization by endovascular procedures or open surgery. Patients with no option or poor option (high risk) for revascularization have the worst prognosis. Regenerative medicine has been studied in this field, by the injection of bone marrow derived stem cells in the ischemic limb to improve neo-angiogenesis. Despite the encouraging first results, few studies have shown a clinical interest of this kind of approach. The products tested were heterogeneous compounds derived from the bone marrow.
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues.
Scientists already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with CLI and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing.
In order to optimize the quality of the AdMSC, to avoid the abdominal sample under anesthesia in the already suffering patients and to have the cellular product available quickly, without waiting the 15 days of culture, researchers envisage the use of AdMSC of allogeneic origin taken from healthy donors and cryopreserved after culture. Indeed, the results of phase 1 of ACellDREAM showed that almost half of the patients suffering from IC had to be amputated during the 15 days of culture. Preliminary experiments show that the phenotypic characteristics, in vitro properties and in vivo biodistribution of these cells after freezing are unchanged.
Researchers are planning a single phase, phase I study to evaluate the tolerability of intramuscular injection of allogeneic AUC in patients with critical non-revascularizable ischemia, or with persistent ischemia despite revascularization.
The aim of this phase I is to evaluate safety of allogeneic AdMSC transplantation in patients with critical limb ischemia with poor options or no option for revascularization. Ten patients will be included and have AdMSC injection in their ischemic leg. Patients will be follow-up during six months to evaluate ulcer evolution, wound healing, pain, blood flow and immune response in blood samples.
343 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 233 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Browse Chronic Limb-Threatening Ischemia studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All the patients will be included and will have AdMSC injections (CellReady®) in their ischemic led. They will be follow-up during 6 months.
Drug: 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.
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
Time frame: 6 months
Evaluation of the efficacy of the treatment on critical limb ischemia.
Proportion of patients without criteria of CLI
Time frame: Day 30, Day 90, and Day 180
Evaluation of the evolution of ischemia objective parameters.
Pressures, laser-Doppler and TcPO2
Time frame: Day 0, Day 30, Day 90, and Day 180
Evaluation of the healing.
Number of complete scarring
Time frame: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients who required a major amputation.
Time frame: Day 180
Evaluation of the pain Evolution
VAS (visual analogue scale), consumption of morphine or non-morphine analgesics
Time frame: Day 0, Day 7, Day 30, Day 90, and Day 180
Evaluation of the neovascularization on the treated leg.
Determination of the number of neo-vessels formed by angiography, angio Magnetic resonance imaging (MRI) or angio-scanner.
Time frame: Day 30, Day 90, and Day 180
Evaluation of the proportion of patients included who had all the injections.
Time frame: Day 0
Evaluation of the evolution of the quality of life
Claudication Scale (CLAU-S®)
Time frame: Day 0, Day 30, Day 90, and Day 180
Evaluation of the security.
Description of all adverse reaction during the trial
Time frame: Day 0, Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the immunomodulatory activity of the injected cells.
- Immuno-monitoring by evaluation of the different circulating immune populations (Th1, Th2, Th17, Treg ...) associated with functional tests in vitro and immunological assays of pro and anti-inflammatory cytokines (IL-1, IL-2, IL-4, IL-6, IL-10, IL-12, TNFα, IFNγ).
Time frame: Evaluated at Day 1, Day 7, Day 30, Day 90, and Day 180
Evaluation of the patient's immune response against Adipose-derived mesenchymal stem cells (AdMSCs)
Dosage of anti HLA (human leukocyte antigen) donor antobodies.
Time frame: Day 30
Evaluation of the evolution of the quality of life.
EuroQol (EQ-5D-5L)
Time frame: Day 0, Day 30, Day 90, and Day 180
Plan to share: No
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Chronic Limb-Threatening Ischemia→
University Hospital, Toulouse