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

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter Phase I/II Clinical Trial, Randomized, Double Blind, Controlled With Placebo to Evaluate Safety and Efficiency of Allogenic Adult Mesenchymal Stem Cells From Adipose Tissue in the Treatment of Draining Fistulas in Patients With Hidradenitis Suppurativa

Conditions
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Hidradenitis Suppurativa

Intervention / Treatment
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* Biological: Injectable suspension of allogeneic adult mesenchymal stem cells
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectable suspension of allogeneic adult mesenchymal stem cells<br>Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally. | Biological: Injectable suspension of allogeneic adult mesenchymal stem cells<br>* Cell therapy treatment will be administered in a single dose at the beginning of the study. The treatment consists of the administration of a single dose of allogeneic adult mesenchymal stem cells from adipose tissue. The dose is 120 million cells (drug volume: 20 ml, concentrated at 6 million cels/ml).<br>|
| Placebo Comparator: Placebo<br>Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid | Other: Placebo<br>* The placebo consists of the administration of the excipient of the suspension without cells. The excipient is a mixture of 50% hyaluronic acid, 49% DMEM without phenol red and 1% L-Alanine-L Glutamine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate | To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa | 24 months | 
| Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate | To evaluate the efficacy of intralesional administration of human allogeneic mesenchymal cells versus the control group, in terms of combined remission of the draining fistula. | 23 months |