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

NCT07230223 | Recruiting Phase 1

• 1 other identifier: shahid beheshti UMS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystrophic Epidermolysis Bullosa; Wound Heal

Outcome Measures

Primary Outcomes (2)

• Rate of wound closure

  percentage reduction in wound area compared to baseline, assessed by digital planimetry

  Day 14

• EBDASI

  EBDASI: epidermolysis bullosa disease activity and scarring index; measured in percentage change to baseline score,

  Day 14, 28, month 3 and month 6

Secondary Outcomes (1)

• pain score (VAS Scale)

  30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Qualified patients who have confirmed chronic wounds (10-50cm2) are included in the study after completing the consent form

Biological: Ev.FV 1.0 x 1011 par/ml

Interventions

Ev.FV 1.0 x 1011 par/ml BIOLOGICAL

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

Treatment

Eligibility Criteria

• Age: 3 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Alzahra Hospital

Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous

Study Officials

• Masoud Soleimani, Prof

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Leila Dehghani, Dr

CONTACT

36202020; l_dehghani2002@yahoo.com

Masoud Soleimani, Prof

CONTACT

03136202020; soleimani.masoud@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Leila Dehghani

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: November 17, 2025
• Study Start: January 9, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 25, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

IR (1)