Clinical trial NCT05962931: Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Venous Ulcer
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
timeFrame: Through study completion, an average of 1 year
measure: Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alfacar
country: Spain
facility: Unidad de A.P. de Alfacar
state: Granada
city: Atarfe
country: Spain
facility: Unidad de A.P. de Atarfe
state: Granada
city: Granada
country: Spain
facility: Universidad de Granada
Study officials:
affiliation: Unidad de A.P. de Atarfe
name: Encarnación González Vigil
role: PRINCIPAL_INVESTIGATOR
affiliation: Unidad de A.P. de Alfacar
name: Mª Ángeles Granado Contrelas
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Granada
name: Victor Costela Ruiz
role: STUDY_DIRECTOR
References: