Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa

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.