Health Trials

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

ConditionsDystrophic Epidermolysis BullosaWound Heal
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-35
SponsorIsfahan University of Medical Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Ev.FV 1.0 x 1011 par/ml

    Biological/Vaccine

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of wound closure

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

Time frame
Day 14
2

EBDASI

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

Time frame
Day 14, 28, month 3 and month 6

Secondary outcomes

1

pain score (VAS Scale)

Change in pain intensity at the wound site measured using VAS Questionnaire

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isfahan University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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