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

Andalusian Network for Design and Translation of Advanced Therapies

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Biological: Injectable suspension of allogeneic adult mesenchymal stem cells; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05934825

HidraQureS/2020

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Injectable suspension of allogeneic adult mesenchymal stem cells

Experimental group

Description:

Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally.

Treatment:

Biological: Injectable suspension of allogeneic adult mesenchymal stem cells

Placebo

Placebo Comparator group

Description:

Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid

Treatment:

Other: Placebo