Study protocol for a randomized clinical trial evaluating the safety and efficacy of autologous adipose-derived stem cell therapy for ulcers in patients with critical limb ischemia

An open randomized clinical trial will be carried out with two groups of twenty patients with CLI: In group 1, 2g of abdominal adipose tissue will be taken to produce ASCs. These cells will then be expanded in a lab (cell processing center) for 14-21 days before being applied to the lesion using bio-dressings and perilesional subcutaneous injections. Group 2 will receive conventional treatment with hydrogel-based dressing. There will be regular clinical assessments, supplementary tests, and photo documentation. The main efficacy outcome will be partial or complete healing of the wound. Safety outcomes will be monitored for infections, gangrene, amputations, and death. Participants will be monitored for 90 days. Cases of major amputation of the studied limb will not be included. The results will be evaluated by an independent external evaluator who is blind to the groups. Considering the high prevalence and socioeconomic consequences related to CLI and limb amputation, this study is expected to provide a positive social and financial impact on the Brazilian Unified Health System. ClinicalTrials.gov: NCT06326203.