Venous Ulcer
Conditions
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.
Interventions
BIOLOGICALBioengineered 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.
PROCEDUREStandard treatment (Control)
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
Sponsors
Andalusian Network for Design and Translation of Advanced Therapies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula. | 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). |
| Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events | 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. |
Countries
Spain
Contacts
Primary ContactOlga Férnández López, PhD
Outcome results
None listed