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Study on the Use of Adipose-Derived Stem Cells for Treating Hidradenitis Suppurativa in Patients with Draining Fistulas

InvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a skin condition called hidradenitis suppurativa. This condition is characterized by painful lumps under the skin, often in areas like the armpits or groin, which can develop into draining fistulas. The trial is testing a new treatment using allogeneic adipose-derived adult mesenchymal stem cells, which are special cells taken from fat tissue and expanded in a lab. These cells are injected directly into the affected areas to see if they can help heal the fistulas.

The purpose of the study is to evaluate the safety and effectiveness of this stem cell treatment. Participants will be randomly assigned to receive either the stem cell treatment or a placebo. The study will monitor participants for any side effects and measure how well the treatment works in closing the fistulas and reducing symptoms over a period of 24 weeks. The trial will also look at changes in symptoms like pain and inflammation, as well as overall quality of life.

Throughout the study, participants will have regular check-ups to assess their progress. The trial aims to provide valuable information on whether this new treatment can offer a safe and effective option for people suffering from hidradenitis suppurativa. The study is expected to continue until 2027, allowing for comprehensive follow-up and analysis of the results.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
Receive an injection of allogeneic adipose-derived adult mesenchymal stem cells directly into the affected area. This is known as intralesional use.
The injection consists of a mixture containing 50% hyaluronic acid, 49% DMEM without phenol red, and 1% L-Alanine-L Glutamine.
Step 2
Monitoring and follow-up
Adverse events and serious adverse events related to the investigational drug will be monitored during the intervention, in the 24 hours afterwards, and throughout the 24-month follow-up period.
The primary goal is to ensure safety and evaluate the effectiveness of the treatment in achieving remission of the draining fistula.
Step 3
Evaluation of treatment efficacy
The effectiveness of the treatment will be assessed by checking for the closure of all draining fistula openings, absence of suppuration, and absence of inflammation, using ultrasound evaluations.
The evaluation will occur 24 weeks after the administration of the treatment.
Step 4
Secondary assessments
Additional assessments will include the anatomical characteristics of the treated fistula, such as location, dimensions, depth, and inflammatory activity.
Changes in symptoms like pain, functional limitation, itching, suppuration, and odor will be measured using a visual analogue scale.
Health-related quality of life will be assessed using the Euroqol-5D-3L questionnaire.
Pro-inflammatory biomarkers will be measured in plasma to monitor changes.

Who can join the trial?

11 criteria

Patients must agree to participate in the clinical trial by giving their informed consent.
Both men and women who can have children must agree to use safe birth control methods during the study and for six months after.
Patients must be willing and able to follow the schedule of visits, treatment plan, and all study procedures.
Patients of any gender must have been diagnosed with **hidradenitis suppurativa** (a skin condition) at least 6 months before joining the study.
Patients must be between 18 and 70 years old.
Patients must have a **draining fistula** (an abnormal connection between two body parts) with at least one tract under the skin and one drainage hole on the skin, which must be actively draining for 4 weeks before joining the study. This will be checked by a doctor and with a skin ultrasound.
Patients must have been treated with **Adalimumab** (a medication) according to its guidelines for at least 12 weeks.
Patients must have normal kidney function or moderate chronic kidney issues, with specific creatinine levels that indicate how well the kidneys are working.
Patients must have normal liver function, with specific bilirubin and transaminase levels that indicate how well the liver is working.
Patients must have a normal blood count and coagulation study, which includes specific levels of white blood cells, neutrophils, platelets, hemoglobin, and other factors that help the blood clot.
Women of childbearing age must have a negative blood pregnancy test result.

Who cannot join the trial?

10 criteria

Patients who are not within the specified age range for the study.
Patients who do not have the condition being studied, which is hidradenitis suppurativa. This is a skin condition that causes small, painful lumps under the skin.
Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.
Patients who have any other medical conditions or factors that the study team believes would make it unsafe for them to participate.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are currently participating in another clinical trial or have recently participated in one.
Patients who have allergies or reactions to the study medication or its ingredients.
Patients who are pregnant or breastfeeding, as the effects of the study medication on unborn babies or infants are not known.
Patients who have a history of drug or alcohol abuse that might interfere with the study.
Patients who have any other reason that the study team believes would make them unsuitable for the study.

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Investigated drugs

Allogeneic Adipose Tissue Adult Stem Mesenchymal Cells are being studied for their potential to treat draining fistulas in patients with hidradenitis suppurativa. These cells are derived from human fat tissue and are expanded in a laboratory setting. The trial aims to assess the safety of these cells when injected directly into the fistulas, monitoring for any adverse effects. Additionally, the study evaluates how effective these cells are in promoting the healing and remission of the fistulas over a period of 24 weeks.

Allogeneic Adipose-Derived Adult Mesenchymal Stem Cells Expanded

What is already known about the treatment

Allogeneic Adipose Tissue Adult Stem Mesenchymal Cells – This investigational medication is administered intralesionally, meaning it is injected directly into the affected area. It is currently being studied in clinical trials for its safety and effectiveness in treating draining fistulas in patients with hidradenitis suppurativa. The main therapeutic indication is to promote healing and remission of these fistulas. At the molecular level, these stem cells are believed to aid in tissue repair and reduce inflammation by modulating the immune response. This medication falls under the pharmacological classification of cell-based therapies.

Investigated diseases

Hidradenitis suppurativa – Hidradenitis suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin and scarring. The condition often starts after puberty and can persist for many years, with periods of flare-ups and remission. The exact cause is not well understood, but it is believed to involve hair follicles becoming blocked and inflamed. It is not contagious and is more common in women than men. The severity of the condition can vary widely among individuals.