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.

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Peripheral artery disease (PAD) can develop into critical limb ischemia (CLI), which is characterized by resting pain at rest, ulcerations, or gangrene, with a high risk of amputation. The optimum course of treatment at this point is arterial revascularization, although this has a significant financial cost and is not always feasible or successful in reducing pain, healing ulcers, or preventing amputations. In situations where traditional alternatives for treating PAD have been exhausted, recent developments in cell therapy may offer a viable substitute. Objective The purpose of this study is to assess the safety and effectiveness of using expanded autologous adipose-derived stem cells (ASCs) in cellular therapy for the treatment of PAD patients who developed chronic artery ulcers. Methods 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 wo

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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