Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol.

ABSTRACT:

Objective

To evaluate the feasibility, safety and efficacy of the cutaneous application of Bioengineered Artificial Mesenchymal Sheet (BAMS) in venous leg ulcers (VLUs) versus conventional treatment.

Methods

This protocol is based on the design of a Phase I/II, multicenter, randomized, controlled, open-label clinical trial investigating the application of a biological dressing supplemented with mesenchymal stem cells (NCT05962931). The clinical trial is being conducted in 2 primary care units within the Granada Metropolitan Health District. A total of 20 patients with VLUs are being randomized (1:1) into 2 intervention arms: a control group and a treatment group. The intervention in the treatment group consists of the local application of 4 doses of BAMS, administered once p

SUBMITTER: Costela-Ruiz VJ 

PROVIDER: S-EPMC12080757 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature