Actively Recruiting
Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
Led by Isfahan University of Medical Sciences · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- DEB diagnosis confirmed by electron microscopy or genetic testing
- Includes severe and milder forms of DEB with absent or reduced collagen VII
- Presence of one or more active wounds between 10 and 50 square centimeters on arms, legs, or trunk
- Willingness to comply with study protocol and provide consent
- Negative urine drug screening at screening visit
You will not qualify if you...
- Clinical evidence of systemic infection
- History of bone marrow transplantation
- Presence of autoimmune disease, including insulin-dependent diabetes
- Significant wound healing prior to treatment (wound closure ≥ 20% during first observation period)
- Severe medical conditions such as malignancy or life expectancy less than 2 years that limit clinical center visits
- Current or recent (past 12 months) history of alcohol or substance abuse requiring treatment
- Positive hepatitis or HIV test results during screening
- Women who are pregnant, lactating, or planning pregnancy during the study
- Women of reproductive age who use birth control pills
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alzahra Hospital
Isfahan, Iran
Actively Recruiting
Research Team
L
Leila Dehghani, Dr
CONTACT
M
Masoud Soleimani, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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