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New treatment option for Dystrophic Epidermolysis Bullosa
Official title Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT07230223
What this study is testing
What is Ev.FV 1.0 x 1011 par/ml?
Ev.FV 1.0 x 1011 par/ml is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dystrophic epidermolysis bullosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 35
You may be able to join if
- DEB participants determined by electron microscopy, or genetic testing. Individuals with severe DEB (eg, RDEB patients with an absence of collagen...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Isfahan, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Isfahan, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.