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

Andalusian Network for Design and Translation of Advanced Therapies20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Ulcer

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.

Standard treatment (Control)PROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signing of the informed consent (IC) after reading the patient information sheet. 2. Over 18 years of both sexes. 3. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2 4. Grade III injury on the Widmer scale. 5. Independence and/or availability to go to the referral center on an outpatient basis. 6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3 Exclusion Criteria: 1. 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. 2. Grade III obesity with a body mass index (BMI) \>40; or underweight patients (BMI \<18.5). 3. Active neoplasia and/or being treated with cytostatics. 4. Patients undergoing radiotherapy treatment in areas close to the lesion. 5. Clinical signs of colonization or local infection of the lesion. 6. Patients with more than one lesion compatible with UV in the same lower limb. 7. Erysipelas. 8. Infectious cellulite. 9. Osteomyelitis. 10. Lymphangitis. 11. Chronic lymphedema. 12. Therapy with corticosteroids or immunosuppressants. 13. Venous ulcer grade I or II on the Widmer scale. 14. Lesions close to possible or diagnosed cancerous lesions. 15. Non-localized wounds in the lower extremities. 16. Ongoing infection and/or sepsis. 17. Critical ischemia in the lower limbs or other venous diseases of unknown origin. 18. Immunocompromised patients. 19. Dependent patients with severe mobility limitations. 20. Dialysis patients.

Locations (3)

Unidad de A.P. de Alfacar

Alfacar, Granada, Spain

RECRUITING

Unidad de A.P. de Atarfe

Atarfe, Granada, Spain

RECRUITING

Universidad de Granada

Granada, Spain

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Through study completion, an average of 1 year

Central Contacts

Olga Férnández López, PhD

CONTACT

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

Data from ClinicalTrials.gov

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