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

Venous Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962931
• Other study ID #: UV/AP/21
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 12, 2023
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: Olga Férnández López, PhD
• Phone: 955 048 366
• Email: ensayosclinicos.radytta.fps[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

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.

Locations

Country	Name	City	State
Spain	Unidad de A.P. de Alfacar	Alfacar	Granada
Spain	Unidad de A.P. de Atarfe	Atarfe	Granada
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Network for Design and Translation of Advanced Therapies

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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