Ev.FV to heal wounds in dystrophic epidermolysis bullosa

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

This trial will test whether Ev.FV, a mesenchymal stem cell-derived extracellular vesicle therapy, helps heal wounds in people with dystrophic epidermolysis bullosa.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 3 Years to 35 Years
• Sex: All
• Sponsor: Isfahan University of Medical Sciences (Academic / other)
• Locations: 1 site (Isfahan)
• Trial ID: NCT07230223 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with dystrophic EB confirmed by genetic testing or electron microscopy who have one or more active wounds of 10–50 cm², can comply with protocol visits, and pass screening including a urine drug screen.

Not a fit: Patients with active systemic infection, a history of bone marrow transplant, established autoimmune disease, or wounds already showing significant healing (≥20% closure) are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, Ev.FV could speed wound closure, reduce painful blistering, and provide a safer cell-free regenerative treatment option for people with DEB.

How similar studies have performed: Preclinical studies and limited early-phase work with MSC-derived extracellular vesicles have shown wound-healing and anti-inflammatory effects, but clinical evidence in DEB is still very limited.

Eligibility criteria

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 this trial is running

Isfahan

• Alzahra Hospital — Isfahan, Iran (Recruiting)

Study contacts

• Study coordinator: Leila Dehghani, Dr

Conditions Dystrophic Epidermolysis Bullosa; Wound Heal