Study on the Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stromal Cells for Patients with Epidermolysis Bullosa

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a new treatment for epidermolysis bullosa, a rare genetic skin condition that causes the skin to be very fragile and to blister easily. The treatment being tested involves the use of allogeneic adipose tissue-derived mesenchymal stromal cells, which are special cells taken from fat tissue and used in a form that can be injected into the skin. These cells are known for their potential to help repair and regenerate damaged tissues.

The main goal of the study is to assess the safety of these cells when they are injected into the skin of patients with epidermolysis bullosa. Participants in the study will receive injections of the cell treatment, and some may receive a placebo. The study will monitor participants for any side effects, such as severe reactions at the injection site or allergic responses, as well as any changes in the condition of their skin. The study will also look at how the treatment affects the healing of skin lesions and the overall area of affected skin.

Throughout the study, participants will be asked to report on their experiences, including any itching or ease of changing wound dressings. The study is designed to gather important information that could lead to new treatment options for people living with epidermolysis bullosa. The trial is expected to continue until 2025, providing valuable insights into the potential benefits and risks of using these special cells for treating this challenging condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age, clinical diagnosis of epidermolysis bullosa, and extent of the disease.

Participants must agree to use prescribed contraceptive methods during the study and for at least six months after the last dose of the study medication.

2 initial assessment

An initial assessment is conducted to evaluate the extent of the disease, which must cover at least 10% of the body surface.

Baseline measurements are taken, including the total area of lesions on the body and patient-reported outcomes such as itching and ease of wound dressing change.

3 administration of study medication

The study medication, allogeneic adipose tissue-derived mesenchymal stromal cells, is administered as a suspension for injection.

The medication is given through intradermal use, which means it is injected into the skin.

4 monitoring and follow-up

Participants are monitored for any adverse events, including severe local reactions at the injection site, systemic allergic reactions, or infectious complications.

Regular follow-up visits are scheduled to assess the safety and efficacy of the treatment, including changes in the non-healed area of lesions and patient-reported outcomes.

5 completion of the study

The study is estimated to end by August 29, 2025.

Upon completion, final assessments are conducted to evaluate the overall safety and efficacy of the treatment.

Who Can Join the Study?

Must be older than 2 years.
Must have a clinical diagnosis of hereditary epidermolysis bullosa (EB), which is confirmed by special tests like electron microscopy (a detailed look at cells) and immunofluorescence antigen mapping (a test to see specific proteins in the skin), as well as DNA analysis (a test to look at genes).
The disease must affect at least 10% of the body surface.
If you can have children, you must agree to use specific birth control methods during the study and for at least 6 months after the last dose of the study medication. For women, this includes using reliable birth control methods like hormonal pills, patches, or devices, or having a partner who has had a vasectomy. For men, this means using a condom or not having sexual intercourse.
Must be willing and able to follow the rules for taking care of the study-related skin areas and attend all scheduled visits and tests during the study.

Who Cannot Join the Study?

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection or illness that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar treatments.
Patients who are unable to follow the study procedures or attend all required visits.
Patients who have a condition that affects their immune system, making them more vulnerable to infections.
Patients who have received certain medications or treatments that could interfere with the study.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fakultni Nemocnice Brno	Brno	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.10.2022

Trial locations

Investigated drugs:

Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded

Allogenic Adipose Tissue-Derived Mesenchymal Stromal Cells are special cells taken from donated fat tissue. These cells are used in the trial to see if they can help treat patients with a skin condition called epidermolysis bullosa. The cells are injected into the skin to check if they are safe and if they can help improve the condition.

Investigated diseases:

Epidermolysis bullosa

Epidermolysis bullosa congenita – This is a rare genetic condition that causes the skin to be extremely fragile, leading to easy blistering and tearing from minor friction or trauma. The disease is present from birth and can affect not only the skin but also mucous membranes inside the body. Blisters can form anywhere on the body, including the hands, feet, and areas subject to friction. Over time, repeated blistering can lead to scarring and changes in skin texture. The severity of the condition can vary widely, with some individuals experiencing mild symptoms and others facing more significant challenges. The disease is caused by mutations in genes responsible for skin integrity, affecting proteins that help bind skin layers together.

Trial ID:

2024-516614-37-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety of Allogeneic Adipose Tissue-Derived Mesenchymal Stromal Cells for Patients with Epidermolysis Bullosa

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