Ev.FV to heal wounds in dystrophic epidermolysis bullosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 interventional trial delivers Ev.FV, mesenchymal stem cell-derived extracellular vesicles containing five bioactive factors, to patients with dystrophic epidermolysis bullosa to promote wound repair and reduce inflammation. Eligible participants have genetically or electron-microscopically confirmed DEB and at least one active wound between 10 and 50 cm² on the arms, legs, or trunk, with exclusions for systemic infection, prior bone marrow transplant, and autoimmune disease. The protocol emphasizes safety and tolerability while measuring wound closure, inflammation markers, and tissue regeneration over scheduled follow-up visits. The single-site trial is led by Isfahan University of Medical Sciences at Alzahra Hospital and uses changes in wound area and clinical safety endpoints as primary outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Alzahra Hospital
  Isfahan, Iran Recruiting

Study contacts

• Study coordinator: Leila Dehghani, Dr
• Email: l_dehghani2002@yahoo.com
• Phone: 36202020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.