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

Andalusian Network for Design and Translation of Advanced Therapies1 site in 1 country30 target enrollmentOctober 26, 2022

ConditionsHidradenitis Suppurativa

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hidradenitis Suppurativa
Sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Enrollment: 30
Locations: 1
Primary Endpoint: Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 26, 2022

End Date

October 26, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate

Time Frame: 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

Time Frame: 24 months

To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa