Actively Recruiting
Safety and Effectiveness of Ev.FV Treatment for Wound Healing in Children and Young Adults with Dystrophic Epidermolysis Bullosa
Led by Isfahan University of Medical Sciences · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dystrophic Epidermolysis Bullosa DEB is a rare genetic skin disease causing fragile skin that blisters and bleeds easily, with severity ranging from mild to life-threatening. It results from mutations affecting collagen VII, which is essential for skin integrity. This trial evaluates the safety and effectiveness of a new cell-free therapy called Ev.FV, derived from mesenchymal stem cell extracellular vesicles, aiming to promote wound healing and skin regeneration in DEB patients. Participants will receive Ev.FV, a biological product containing five factors, through intravenous doses given six times every two weeks. These nanovesicles carry molecules that can reduce inflammation, stimulate skin cell growth, promote blood vessel formation, and potentially repair the skins anchoring structures. The study focuses on patients with chronic wounds sized between 10 and 50 square centimeters and includes assessments over several months to monitor wound healing and skin condition. During the trial, patients will undergo evaluations including wound closure rates measured at day 14, and skin disease activity scores at multiple time points up to six months. Pain levels will also be tracked using a visual scale over 30 days. Researchers will monitor safety, treatment effects, and how well the wounds heal. The total study duration includes follow-up visits to ensure comprehensive observation of the therapys impact.
CONDITIONS
Brief Title
Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with dystrophic epidermolysis bullosa confirmed by electron microscopy or genetic testing
- Have one or more active wounds between 10 and 50 square centimeters on arms, legs, or trunk
- Willing to comply with study requirements and provide consent
- Negative urine drug screening at enrollment
You will not qualify if you...
- Evidence of systemic infection
- History of bone marrow transplantation
- Presence of autoimmune disease, including insulin-dependent diabetes
- Significant wound healing prior to treatment (closure ≥ 20% at first observation)
- Severe medical conditions such as malignancy or limited life expectancy under 2 years
- Current or recent history (past 12 months) of alcohol or substance abuse requiring treatment
- Positive hepatitis or HIV test at screening
- Pregnant, lactating, or planning pregnancy during the study
- Women of reproductive age using birth control pills
Research Team
L
Leila Dehghani, Dr
M
Masoud Soleimani, Prof
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