Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Phase 1/2 Unknown 20 enrolled Andalusian Network for Design and Translation of Advanced Therapies

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.

Timeline

Start: 2023-07-12
Primary completion: 2025-07
Completion: 2025-07

Publications

Costela-Ruiz VJ, Gonzalez-Vigil E, Espinosa-Ibanez O, Alcazar-Caballero RM, Melguizo-Rodriguez L, Fernandez-Lopez O, Arias-Santiago S. Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol. PLoS One. 2025 May 15;20(5):e0323173. doi: 10.1371/journal.pone.0323173. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bioengineered Artificial Mesenchymal Sheet	Cell therapy	—	Topical

Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Summary

Timeline

Publications

Drugs

Indications