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

NCT05962931 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Andalusian Network for Design and Translation of Advanced Therapies

    lead OTHER

Principal Investigators

  • Encarnación González Vigil · Unidad de A.P. de Atarfe

  • Mª Ángeles Granado Contrelas · Unidad de A.P. de Alfacar

  • Victor Costela Ruiz · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-12
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962931 on ClinicalTrials.gov