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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

December 31, 2027

Conditions
Peripheral Arterial DiseaseLeg 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.

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

lead

UPECLIN HC FM Botucatu Unesp

OTHER

NCT06326203 - Cell Therapy for Lower Limb Ulcers in Patients With Critical Limb Ischemia | Biotech Hunter | Biotech Hunter