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

NCT05962931 | Unknown Phase 1

• 1 other identifier: UV/AP/21
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.

  To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).

  Through study completion, an average of 1 year

• Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events

  To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.

  Through study completion, an average of 1 year

Study Arms (2)

Bioengineered Artificial Mesenchimal Sheet (BAMS)

EXPERIMENTAL

Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix

Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)

Standard treatment (Control)

ACTIVE COMPARATOR

Standard treatment

Procedure: Standard treatment (Control)

Interventions

Bioengineered Artificial Mesenchimal Sheet (BAMS) BIOLOGICAL

Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.

Bioengineered Artificial Mesenchimal Sheet (BAMS)

Standard treatment (Control) PROCEDURE

Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.

Standard treatment (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing of the informed consent (IC) after reading the patient information sheet.
• Over 18 years of both sexes.
• Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
• Grade III injury on the Widmer scale.
• Independence and/or availability to go to the referral center on an outpatient basis.
• Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3

You may not qualify if:

• Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
• Grade III obesity with a body mass index (BMI) \>40; or underweight patients (BMI \<18.5).
• Active neoplasia and/or being treated with cytostatics.
• Patients undergoing radiotherapy treatment in areas close to the lesion.
• Clinical signs of colonization or local infection of the lesion.
• Patients with more than one lesion compatible with UV in the same lower limb.
• Erysipelas.
• Infectious cellulite.
• Osteomyelitis.
• Lymphangitis.
• Chronic lymphedema.
• Therapy with corticosteroids or immunosuppressants.
• Venous ulcer grade I or II on the Widmer scale.
• Lesions close to possible or diagnosed cancerous lesions.
• Non-localized wounds in the lower extremities.

Sponsors & Collaborators

• Andalusian Network for Design and Translation of Advanced Therapies: lead

Study Sites (3)

Unidad de A.P. de Alfacar

Alfacar, Granada, 18170, Spain

RECRUITING

Unidad de A.P. de Atarfe

Atarfe, Granada, 18290, Spain

RECRUITING

Universidad de Granada

Granada, 18071, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40373055 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Encarnación González Vigil

  Unidad de A.P. de Atarfe

  PRINCIPAL INVESTIGATOR

• Mª Ángeles Granado Contrelas

  Unidad de A.P. de Alfacar

  PRINCIPAL INVESTIGATOR

• Victor Costela Ruiz

  Universidad de Granada

  STUDY DIRECTOR

Central Study Contacts

Olga Férnández López, PhD

CONTACT

955 048 366; ensayosclinicos.radytta.fps@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 27, 2023
• Study Start: July 12, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

ES (3)