RecruitingPhase 1Phase 2NCT07230223

Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa

Safety and Efficacy of Ev.FV in Epidermolysis Bullosa Patients, A Randomized Clinical Trial, Phase 1 , 2

Sponsor

Isfahan University of Medical Sciences

Enrollment

20 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Wound Heal Dystrophic Epidermolysis Bullosa

Summary

Epidermolysis bullosa (EB) is a hereditary disease of skin tissues that causes painful bleeding blisters in the skin and mucous membrane. The prevalence of this disease is 1 in 50,000. The severity of the disease varies depending on the type of disease and may even lead to death. This disease is caused by a genetic mutation in keratin or collagen, and its incidence is the same in all men and women of different human races. In these patients, the skin becomes extremely fragile and peels off with the slightest scratch. Many blisters are one of the most obvious symptoms of this disease. The possibility of skin cancer in people suffering from this disease is more than others. Nowadays, the preference of cell therapy methods is to use biological products produced by cells such as extracellular vesicles and mitochondria instead of stem cells. The use of Extracellular vesicles and engineered EVs as messenger carriers can introduce a new treatment method based on cell products for skin regeneration and as an alternative to cell therapy. Therefore, in this study, EV.FV will be applied topically to patients.

Eligibility

Min Age: 3 YearsMax Age: 35 Years

Inclusion Criteria4

DEB participants determined by electron microscopy, or genetic testing. Individuals with severe DEB (eg, RDEB patients with an absence of collagen VII) and milder forms of DEB (eg, RDEB patients with reduced levels of collagen VII) will be eligible.
People with one or more active wounds (each between 10 and 50 square centimeters on the arms, legs or trunk.)
Participants must be willing to comply with the requirements of the protocol and have consent to participate in the project.
Participants must be negative in the urine drug screening visit.

Exclusion Criteria9

Participants with clinical evidence of systemic infection.
Participants have a history of bone marrow transplantation.
Participants must have evidence of autoimmune disease, including insulin-dependent diabetes.
Participant has evidence of significant wound healing prior to treatment (ie, wound closure ≥ 20% during treatment at the first observation period).
Participant has a severe medical condition, such as malignancy (including skin cancer), life expectancy less than 2 years, which limits movement to the clinical center.
Participants have a current history of alcohol or substance abuse or a history of alcohol or substance abuse that requires treatment in the past 12 months.
People participating in the screening should have a positive hepatitis and human immunodeficiency virus (HIV) test result.
Women who are pregnant, lactating or planning to become pregnant during the study
Women who are of reproductive age and use birth control pills.

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