Using stem cells to treat venous ulcers in 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

This study is testing whether a new treatment using stem cells can help heal venous ulcers in the lower legs better than the usual care.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies (Academic / other)
• Locations: 3 sites (Alfacar, Granada and 2 other locations)
• Trial ID: NCT05962931 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility, safety, and efficacy of using allogenic adipose-derived adult mesenchymal stem cells expanded on a fibrin-hyaluronic biological matrix for treating venous ulcers in the lower limbs. It is a multicenter, randomized, controlled trial conducted in phases I and II. Participants will receive either the bioengineered artificial mesenchymal sheet or standard treatment to compare outcomes. The study aims to provide insights into a novel therapeutic approach for a challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with active or recurrent venous ulcers measuring between 5-10 cm².

Not a fit: Patients with contraindications for compression bandaging, severe obesity, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates and quality of life for patients suffering from venous ulcers.

How similar studies have performed: While the use of stem cells in wound healing is an emerging field, this specific approach is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Alfacar, Granada and 2 other locations

• 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)

Study contacts

• Principal investigator: Encarnación González Vigil — Unidad de A.P. de Atarfe
• Study coordinator: Olga Férnández López, PhD

Conditions Venous Ulcer