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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Venous Ulcer

Intervention / Treatment
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* Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)
* Procedure: Standard treatment (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. Ongoing infection and/or sepsis. Critical ischemia in the lower limbs or other venous diseases of unknown origin. Immunocompromised patients. Dependent patients with severe mobility limitations. Dialysis patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioengineered Artificial Mesenchimal Sheet (BAMS)<br>Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix | Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)<br>* Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.<br>|
| Active Comparator: Standard treatment (Control)<br>Standard treatment | Procedure: Standard treatment (Control)<br>* Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.<br>|

What is the study measuring?
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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 |