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

NCT05934825 | Unknown Phase 1 DMC

• 1 other identifier: HidraQureS/2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Injectable suspension of allogeneic adult mesenchymal stem cells

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Injectable suspension of allogeneic adult mesenchymal stem cells 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).

Injectable suspension of allogeneic adult mesenchymal stem cells

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who give informed consent for participation in the clinical trial
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andalusian Network for Design and Translation of Advanced Therapies: lead

Study Sites (1)

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

RECRUITING

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Central Study Contacts

María del Mar Macías Sánchez

CONTACT

671 533 802; mmar.macias@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: July 7, 2023
• Study Start: October 26, 2022
• Primary Completion: October 26, 2025
• Study Completion: October 26, 2025
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

ES (1)