NCT05962931

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	Bioengineered Artificial Mesenchimal Sheet (BAMS)	Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
PROCEDURE	Standard treatment (Control)	Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.

Timeline

• Start date: 2023-07-12
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

3 sites across 1 country: Spain