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RECRUITING
NCT07230223
PHASE1/PHASE2

Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa

Sponsor: Isfahan University of Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-01-09

Completion Date

2026-12-25

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

Ev.FV 1.0 x 1011 par/ml

Ev.FV 1.0 x 1011 par/ml, IV, Total of 6 doses every 2weeks

Locations (1)

Alzahra Hospital

Isfahan, Iran