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

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ClinicalTrials.gov Identifier: NCT05962931
Recruitment Status : Recruiting
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Venous Ulcer Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS) Procedure: Standard treatment (Control) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2023
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula. [ Time Frame: Through study completion, an average of 1 year ]
    To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).

  2. Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events [ Time Frame: Through study completion, an average of 1 year ]
    To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05962931


Contacts
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Contact: Olga Férnández López, PhD 955 048 366 ext 0034 ensayosclinicos.radytta.fps@juntadeandalucia.es

Locations
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Spain
Unidad de A.P. de Alfacar Recruiting
Alfacar, Granada, Spain, 18170
Contact: Mª Ángeles Granado Contrelas         
Unidad de A.P. de Atarfe Recruiting
Atarfe, Granada, Spain, 18290
Contact: Encarnación González Vigil         
Universidad de Granada Recruiting
Granada, Spain, 18071
Contact: Victor Costela Ruiz         
Sponsors and Collaborators
Andalusian Network for Design and Translation of Advanced Therapies
Investigators
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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
More Information
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Responsible Party: Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier: NCT05962931    
Other Study ID Numbers: UV/AP/21
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varicose Ulcer
Ulcer
Pathologic Processes
Varicose Veins
Vascular Diseases
 Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases