NCT07230223 Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
| NCT ID | NCT07230223 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Isfahan University of Medical Sciences |
| Condition | Dystrophic Epidermolysis Bullosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01-09 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The severity of the disease varies depending on the type of disease and may even lead to death. This disease is caused by a genetic mutation in keratin or collagen, and its incidence is the same in all men and women of different human races. In these patients, the skin becomes extremely fragile and peels off with the slightest scratch. Many blisters are one of the most obvious symptoms of this disease. The possibility of skin cancer in people suffering from this disease is more than others. Nowadays, the preference of cell therapy methods is to use biological products produced by cells such as extracellular vesicles and mitochondria instead of stem cells. The use of Extracellular vesicles and engineered EVs as messenger carriers can introduce a new treatment method based on cell products for skin regeneration and as an alternative to cell therapy. Therefore, in this study, EV.FV will be applied topically to patients.
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.
Contact & Investigator
Masoud Soleimani, Prof
STUDY DIRECTOR
Shahid Beheshti University of Medical Sciences
Frequently Asked Questions
Who can join the NCT07230223 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 35 Years, studying Dystrophic Epidermolysis Bullosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07230223 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07230223 currently recruiting?
Yes, NCT07230223 is actively recruiting participants. Contact the research team at l_dehghani2002@yahoo.com for enrollment information.
Where is the NCT07230223 trial being conducted?
This trial is being conducted at Isfahan, Iran.
Who is sponsoring the NCT07230223 clinical trial?
NCT07230223 is sponsored by Isfahan University of Medical Sciences. The principal investigator is Masoud Soleimani, Prof at Shahid Beheshti University of Medical Sciences. The trial plans to enroll 20 participants.