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

Primary Purpose

Hidradenitis Suppurativa

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Injectable suspension of allogeneic adult mesenchymal stem cells
Placebo
Sponsored by
Andalusian Network for Design and Translation of Advanced Therapies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen de Las NievesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Injectable suspension of allogeneic adult mesenchymal stem cells

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2023
Last Updated
July 6, 2023
Sponsor
Andalusian Network for Design and Translation of Advanced Therapies
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1. Study Identification

Unique Protocol Identification Number
NCT05934825
Brief Title
Clinical Trial to Evaluate Safety and Efficiency of Mesenchymal Stem Cell in Patients With Hidradenitis Suppurativa
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
October 26, 2025 (Anticipated)
Study Completion Date
October 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andalusian Network for Design and Translation of Advanced Therapies

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injectable suspension of allogeneic adult mesenchymal stem cells
Arm Type
Experimental
Arm Description
Patients will receive an injectable suspension of allogeneic adult mesenchymal stem cells from adipose tissue intralesionally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive the cell-free suspension vehicle: 49% DMEM without phenol red, 1% L-Alanine LGlutamine and 50% hyaluronic acid
Intervention Type
Biological
Intervention Name(s)
Injectable suspension of allogeneic adult mesenchymal stem cells
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Description
To determine the safety of intralesional administration of allogeneic mesenchymal cells in draining fistulas in patients with hidradenitis suppurativa
Time Frame
24 months
Title
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
Description
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.
Time Frame
23 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María del Mar Macías Sánchez
Phone
671 533 802
Email
mmar.macias@juntadeandalucia.es
Facility Information:
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALEJANDRO MOLINA LEYVA
Email
alejandromolinaleyva@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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