Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
NCT ID: NCT05962931
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2023-07-12
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bioengineered Artificial Mesenchimal Sheet (BAMS)
Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix
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.
Standard treatment (Control)
Standard treatment
Standard treatment (Control)
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
Interventions
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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.
Standard treatment (Control)
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Andalusian Network for Design and Translation of Advanced Therapies
OTHER
Responsible Party
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Principal Investigators
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Encarnación González Vigil
Role: PRINCIPAL_INVESTIGATOR
Unidad de A.P. de Atarfe
Mª Ángeles Granado Contrelas
Role: PRINCIPAL_INVESTIGATOR
Unidad de A.P. de Alfacar
Victor Costela Ruiz
Role: STUDY_DIRECTOR
Universidad de Granada
Locations
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Unidad de A.P. de Alfacar
Alfacar, Granada, Spain
Unidad de A.P. de Atarfe
Atarfe, Granada, Spain
Universidad de Granada
Granada, , Spain
Countries
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Central Contacts
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Facility Contacts
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Mª Ángeles Granado Contrelas
Role: primary
Encarnación González Vigil
Role: primary
Victor Costela Ruiz
Role: primary
References
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Costela-Ruiz VJ, Gonzalez-Vigil E, Espinosa-Ibanez O, Alcazar-Caballero RM, Melguizo-Rodriguez L, Fernandez-Lopez O, Arias-Santiago S. Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol. PLoS One. 2025 May 15;20(5):e0323173. doi: 10.1371/journal.pone.0323173. eCollection 2025.
Other Identifiers
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UV/AP/21
Identifier Type: -
Identifier Source: org_study_id
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