Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia

Summary

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.

Conditions

• Peripheral Arterial Disease
• Leg Ulcer

Interventions

BIOLOGICAL

CELULAS TRONCO

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.

DEVICE

CONVENTIONAL DRESSING

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.

Sponsors & Collaborators

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• UPECLIN HC FM Botucatu Unesp

  lead OTHER

Principal Investigators

• Francisco J de Oliveira Filho, M.D. · São Paulo State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-03-31

Completion

2028-03-31