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

NCT ID: NCT05934825

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2025-10-26

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

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Injectable suspension of allogeneic adult mesenchymal stem cells

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

Group Type: EXPERIMENTAL

Injectable suspension of allogeneic adult mesenchymal stem cells

Intervention Type: BIOLOGICAL

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).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

Injectable suspension of allogeneic adult mesenchymal stem cells

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).

Intervention Type: BIOLOGICAL

Placebo

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andalusian Network for Design and Translation of Advanced Therapies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Virgen de Las Nieves

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

María del Mar Macías Sánchez

Role: CONTACT

mmar.macias@juntadeandalucia.es

671 533 802

Facility Contacts

ALEJANDRO MOLINA LEYVA

Role: primary

alejandromolinaleyva@gmail.com

Other Identifiers

HidraQureS/2020

Identifier Type: -

Identifier Source: org_study_id