clinical trial to evaluate safety and efficiency of mesenchymal stem cell in patients with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: multicenter phase i/ii clinical trial to evaluate safety and efficiency of allogenic adult mesenchymal stem cell from adipose tissue in patients with hidradenitis suppurativa


Eligibility criteria:
inclusion criteria: * patients who give informed consent for participation in the clinical trial * diagnosed 6 months before inclusion * drainage fistula with a minimum of 1 subcutaneous tract and 1 cutaneous drainage orifice evaluated clinically and by cutaneous ultrasound. the fistula must have active drainage 4 weeks prior to inclusion * treatment with adalimumab for at least 12 weeks. * normal renal function or moderate chronic renal insufficiency with creatinine clearance values greater than 60 ml/min or serum creatinine less than 1.5 times the upper limit. * normal liver function with total bilirubin values less than 1.5 times the upper limit of normal and transaminases \< 2.5 times the upper limit of normal. * hemogram and coagulation studies within normal values (leukocytes ≥ 3000, neutrophils ≥ 1500, platelets ≥ 100000, hemoglobin\>10g/dl). * negative blood pregnancy test for patients of childbearing age * acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up. * willingness and ability to comply with the visit schedule, treatment plan, clinical tests and all study procedures. and all study procedures. exclusion criteria: * poorly controlled hs requiring additional systemic treatment or change of baseline anti-inflammatory therapy * abscess or inflammatory collection \> 2 cm adjacent to the fistula to be treated. * previous surgical treatment on the draining fistula * known history of alcohol abuse in the 6 months prior to study entry * active malignancy or patients with a history of a previous malignant tumor. * presence or recent history of severe, progressive and uncontrolled hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or skin disease * congenital or acquired immunodeficiencies * positive serology for hiv, hcv or hbv. * active covid-19 infection confirmed by serology and pcr or rapid antigen test * allergy to any of the components/excipients of the investigational product * major surgery or severe trauma in the previous 6 months * patients unwilling or unable to comply with study procedures. * anticipated need for surgery in the anatomical area for a reason other than hidradenitis suppurative * contraindication to the anesthetic procedure * systemic immunomodulatory biologic therapy other than adalimumab, topical or systemic antibiotics for hs, systemic or intralesional corticosteroids, live vaccines, or any experimental treatment or intervention study participation. * contraindication of nuclear magnetic resonance with contrast. * women who are pregnant, breastfeeding, or of childbearing age who are not using an effective contraceptive method. * patients who are currently participating or have completed participation in a clinical trial in a period of less than 3 months or who have participated in an advanced therapies clinical trial at any previous time and have been assigned to an experimental group.