Could Cell-Derived vesicles heal skin wounds in epidermolysis bullosa?
NCT ID NCT07230223
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1/2 trial tests a topical treatment called Ev.FV, made from cell-derived particles, to help heal wounds in people with dystrophic epidermolysis bullosa (DEB), a genetic skin condition causing painful blisters. The study will enroll 20 participants with active wounds and measure wound closure and disease activity over several weeks. It is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ev.FV (extracellular vesicles)
- What this could lead to
- If successful, this could point toward a new topical treatment to help heal wounds in people with epidermolysis bullosa.
- What could go wrong
- This is a very early phase 1/2 trial with only 20 participants, so results may not apply to all patients. The treatment may not improve wound healing or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 to 35 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dystrophic epidermolysis bullosa are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Alzahra Hospital
RECRUITINGIsfahan, Iran
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a placental patch help heal stubborn diabetic foot ulcers?
- Emergency wound study aims to predict which stitches will fail
- Smartphone app could let diabetic foot ulcer patients skip clinic visits for wound checks
- Gum healing boost? scientists test hyaluronic acid and polynucleotides
- Could a Placenta-Derived powder revolutionize wound healing after skin cancer surgery?
- Which heals better below the knee? stitches vs. natural healing