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

Phase 1

Recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Other: Placebo; Biological: Injectable suspension of allogeneic adult mesenchymal stem cells

• Registration Number: NCT05934825
• Lead Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-26
• Study First Submitted: 2023-03-17
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Primary Completion: 2025-10-26
• Study Completion: 2025-10-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid
Injectable suspension of allogeneic adult mesenchymal stem cells	Injectable suspension of allogeneic adult mesenchymal stem cells	Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally.

Primary Outcome Measures

Name	Time	Method
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate	23 months	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.
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate	24 months	To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa

Trial Locations

Locations (1)

Hospital Universitario Virgen de Las Nieves; 🇪🇸 Granada, Spain