Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrin-hyaluronic biological matrix for Venous leg ulcer

Inclusion criteria

• {"criterion_text":"- 1.\tSigning of the informed consent (IC) after reading the patient information sheet."}
• {"criterion_text":"- 2.\tOver 18 years of both sexes."}
• {"criterion_text":"- 3.\tActive or recurrent venous ulcer (C6 according to the CEAC clinical classification, Annex 5)” in the lower extremity with an area between 5-10 cm2."}
• {"criterion_text":"- 4.\tGrade III injury on the Widmer scale."}
• {"criterion_text":"- 5.\tDistal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3."}

Exclusion criteria

• {"criterion_text":"- 1.\tAny 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. The following comorbidities will be allowed: peripheral vascular disease, coronary heart disease, chronic kidney disease, chronic liver disease, and arterial hypertension."}
• {"criterion_text":"- 2.\tGrade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5)."}
• {"criterion_text":"- 3.\tActive neoplasia and/or being treated with cytostatics."}
• {"criterion_text":"- 4.\tPatients undergoing radiotherapy treatment in areas close to the lesion."}
• {"criterion_text":"- 5.\tClinical signs of colonization or local infection of the lesion."}
• {"criterion_text":"- 6.\tLymphangitis in the limb to be treated."}
• {"criterion_text":"- 7.\tChronic lymphedema in the limb to be treated."}
• {"criterion_text":"- 8.\tVenous ulcer grade I or II on the Widmer scale."}
• {"criterion_text":"- 9.\tLesions close to possible or diagnosed cancerous lesions."}
• {"criterion_text":"- 10.\tNon-localized wounds in the lower extremities."}
• {"criterion_text":"- 11.\tOngoing systemic infection."}
• {"criterion_text":"- 12.\tCritical ischemia in the lower limbs or other venous diseases of unknown origin."}
• {"criterion_text":"- 13.\tImmunocompromised patients."}
• {"criterion_text":"- 14.\tDialysis patients."}
• {"criterion_text":"- 15.\tThalassemia patients."}
• {"criterion_text":"- 16.\tDecompensated heart failure."}
• {"criterion_text":"- 17.\tPregnant and lactating women."}
• {"criterion_text":"- 18.\tAny other recurrent illness or condition that, in the opinion of the investigator, would make the patient ineligible to participate in the trial."}

Primary endpoints

• {"endpoint_text":"- Feasibility and Safety","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 1.\tTo determine the effect of the experimental treatment on wound closure time compared to the control group.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 2.\tTo assess the effect of the experimental treatment on the healing evolution of the lesion, in terms of depth, size, type of edges, tissue and exudate compared to the control group.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 3.\tTo assess the effect of the experimental treatment on the concentration of growth factors closely related to wound healing (cytokines IL-6, IL-4, TGF-β1 and IL-10) in the exudate of the lesion in on day 0, +7, +14, +21 and +28 compared to the control group and its possible relationship with the rest of the efficacy parameters.","definition_or_measurement_approach":"Measurement of cytokine concentrations (IL-6, IL-4, TGF-β1, IL-10) in lesion exudate on days 0, 7, 14, 21 and 28."}
• {"endpoint_text":"- 4.\tEvaluate the evolution of pain derived from the presence of UVs in the group treated with the PEI, in comparison with the control group.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 5.\tTo determine the perceived quality of life after treatment with the experimental treatment compared to the control group.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

15-04-2024

Latest Decision Or Authorization Date

22-04-2024

Processing Time Days

7

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Fundacion Progreso Y Salud

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain