Peripheral arterial disease (PAD) can progress to critical limb ischemia (CLI) of the affected lower limb, characterized by pain at rest, ulcerations or gangrene, with a high risk of amputation. In this phase, the best treatment is arterial limb revascularization, but this is not always possible or even effective for promoting pain relief, healing of ulcers or preventing amputations, in addition to the high socioeconomic cost caused by the disease. Recent advances in cell therapy represent a promising supporting alternative for the treatment of PAD in cases where conventional alternatives have run out. Objective: To evaluate the safety and efficacy of cell therapy with expanded autologous mesenchymal stem cells in the treatment of patients with PAD with CLI and chronic arterial ulcers. Methods: An open randomized clinical study will be performed with 2 groups of 20 patients with CLI: in group 1, a fragment of abdominal fat tissue (10g) will be collected to obtain mesenchymal stem cells, which will be expanded and applied using subcutaneous perilesional injection in the affected lower limb, in addition to the application in the form of a personalized curative biological on the wounds. Group 2 will receive conventional treatment with a Hydrogel dressing with essential fatty acids. Periodic clinical evaluations, complementary exams and photographic record will be carried out. The main outcome of effectiveness will be partial or total wound healing. Safety outcomes will be monitored for infections, gangrene, amputations and deaths. Participants will be monitored for 120 days. Major amputation cases will not be included. An independent external evaluator and blind to the groups will evaluate the results. It is an innovative procedure with high impact and financial return for SUS, in view of the high prevalence of the disease and the high socioeconomic impact of the disease when it progresses to limb amputation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Cellular Therapy Treatment: The treatment will consist of \*\*20 participants (n=20) who will receive treatment with expanded mesenchymal stem cells (MSCs). The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive MSC application via perilesional injections and a biocovering produced by the study team, also containing the same cells (single session - the MSC-containing dressing will remain in contact with the ulcer for 7 days). After removal of the biological dressing, the ulcer will receive local care with a topical hydrogel dressing, dry gauze, and a crepe bandage, with a minimum of one change per day.
The control group will consist of 20 participants (n=20) who will receive local care for the ulcer. The patient will undergo a surgical debridement procedure for the ulcer to be in its optimal condition (Visit 1). Subsequently, the patient will receive the application of a conventional dressing with Hydrogel, dry gauze, and a crepe bandage. The patient will be instructed to change the dressing at least once a day.
Major Amputation
Defined by total number of patients subjected to amputation at the knee or tight level.
Time frame: 120 days
Ulcer Healing
Defined by total or partial epithelization of the ulcer as measured in total square centimeters.
Time frame: 7, 30, 60, 90 and 120 days
Lenize S Rodrigues, Ph.D.
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