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

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 Overview

• Status: Recruiting
• Conditions: Venous Ulcer
• Intervention / Treatment: Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS); Procedure: Standard treatment (Control)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Olga Férnández López, PhD; Phone Number: 0034 955 048 366; Email: ensayosclinicos.radytta.fps@juntadeandalucia.es

Study Locations

• Spain
  • Granada, Spain, 18071
    • Recruiting
    • Universidad de Granada
    • Contact: Victor Costela Ruiz
  • Granada
    • Alfacar, Granada, Spain, 18170
      • Recruiting
      • Unidad de A.P. de Alfacar
      • Contact: Mª Ángeles Granado Contrelas
    • Atarfe, Granada, Spain, 18290
      • Recruiting
      • Unidad de A.P. de Atarfe
      • Contact: Encarnación González Vigil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioengineered Artificial Mesenchimal Sheet (BAMS); Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix	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.
Active Comparator: Standard treatment (Control); Standard treatment	Procedure: Standard treatment (Control); Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Andalusian Network for Design and Translation of Advanced Therapies
• Investigators: Principal Investigator: Encarnación González Vigil, Unidad de A.P. de Atarfe; Principal Investigator: Mª Ángeles Granado Contrelas, Unidad de A.P. de Alfacar; Study Director: Victor Costela Ruiz, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: UV/AP/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No