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

July 6, 2023 updated by: Andalusian Network for Design and Translation of Advanced Therapies

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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.
23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Estimated)

October 26, 2025

Study Completion (Estimated)

October 26, 2025

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HidraQureS/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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