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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05934825
Recruitment Status : Recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies

Study Description
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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

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: Injectable suspension of allogeneic adult mesenchymal stem cells Other: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 26, 2022
Estimated Primary Completion Date : October 26, 2025
Estimated Study Completion Date : October 26, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Injectable suspension of allogeneic adult mesenchymal stem cells
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
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 Comparator: Placebo
Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05934825


Contacts
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Contact: María del Mar Macías Sánchez 671 533 802 mmar.macias@juntadeandalucia.es

Locations
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Spain
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Spain, 18014
Contact: ALEJANDRO MOLINA LEYVA       alejandromolinaleyva@gmail.com   
Sponsors and Collaborators
Andalusian Network for Design and Translation of Advanced Therapies
More Information
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Responsible Party: Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier: NCT05934825    
Other Study ID Numbers: HidraQureS/2020
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration