Dystrophic Epidermolysis BullosaPhase 1/2NCT07230223
Effect of Ev.FV on Wound Healing in Dystrophic Epidermolysis Bullosa
A Phase 1/2 study testing Ev.FV 1.0 x 1011 par/ml in people with Dystrophic Epidermolysis Bullosa and Wound Heal, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Dystrophic Epidermolysis Bullosa, Wound Heal
- What is being tested?
- Ev.FV 1.0 x 1011 par/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 9 Jan 2024to 25 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Alzahra Hospital
Isfahan
Leila Dehghani, Prof, 36202020 ext. 031, l_dehghani2002@yahoo.com
Masoud Soleimani, Prof, 36202020 ext. 031, soleimani.masoud@gmail.com
About this study
Official title: Safety and Efficacy of Ev.FV in Epidermolysis Bullosa Patients, A Randomized Clinical Trial, Phase 1 , 2
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.
Read the detailed description
Mesenchymal stem cell-derived EV which included Five Factors act as cell-free nanovesicles that mediate intercellular communication by transferring functional biomolecules including mRNA, microRNA, proteins, and lipids to recipient skin cells. In dystrophic epidermolysis bullosa, these exosomes facilitate wound repair and regeneration through several mechanisms: (1) modulation of inflammation by down-regulating pro-inflammatory cytokines; (2) stimulation of fibroblast and keratinocyte proliferation and migration; (3) promotion of angiogenesis via vascular endothelial growth factor (VEGF) signaling; and (4) potential delivery of collagen VII related proteins and mRNAs that support dermal epidermal junction repair. Thus, the therapeutic benefit of exosome therapy arises from paracrine signaling and molecular cargo transfer rather than cell engraftment, providing a safer and more controlled alternative to live stem cell transplantation.
Our study focused on dystrophic EB (DEB), the most severe form, where loss of collagen VII disrupts anchoring fibrils and dermal-epidermal adhesion. This pathology makes DEB an appropriate target for regenerative therapies such as mesenchymal stem cell-derived EVs and investigates if EVs from MSCs are safe and effective for treating DEB. It will examine how well these exosomes help heal wounds and promote tissue regeneration, hoping to find a new biological treatment option for this challenging disease.
- Conditions
- Dystrophic Epidermolysis Bullosa, Wound Heal
- Being tested
- Ev.FV 1.0 x 1011 par/ml
- Medical subject headings
- Epidermolysis Bullosa Dystrophica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ev.FV 1.0 x 1011 par/mlBiological
Ev.FV 1.0 x 1011 par/ml, IV, Total of 6 doses every 2weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Qualified patients who have confirmed chronic wounds (10-50cm2) are included in the study after completing the consent form Receives: Biological: Ev.FV 1.0 x 1011 par/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound closure
percentage reduction in wound area compared to baseline, assessed by digital planimetry
Measured: Day 14
EBDASI
EBDASI: epidermolysis bullosa disease activity and scarring index; measured in percentage change to baseline score,
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start9 Jan 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dystrophic Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Dehghani, Isfahan University of Medical Sciences
- Investigators
- Masoud Soleimani, Prof, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230223
- Sponsor's protocol ID
- shahid beheshti UMS
- Status last verified
- Nov 2025
- First submitted
- 28 Jun 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ev.FV in Epidermolysis Bullosa Patients, A Randomized Clinical Trial, Phase 1 , 2
- ClinicalTrials.gov ID
- NCT07230223
- Acronym / sponsor ID
- shahid beheshti UMS
- Conditions
- Dystrophic Epidermolysis Bullosa, Wound Heal
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mesenchymal stem cell-derived EV which included Five Factors act as cell-free nanovesicles that mediate intercellular communication by transferring functional biomolecules including mRNA, microRNA, proteins, and lipids to recipient skin cells. In dystrophic epidermolysis bullosa, these exosomes facilitate wound repair and regeneration through several mechanisms: (1) modulation of inflammation by down-regulating pro-inflammatory cytokines; (2) stimulation of fibroblast and keratinocyte proliferation and migration; (3) promotion of angiogenesis via vascular endothelial growth factor (VEGF) signaling; and (4) potential delivery of collagen VII related proteins and mRNAs that support dermal epidermal junction repair. Thus, the therapeutic benefit of exosome therapy arises from paracrine signaling and molecular cargo transfer rather than cell engraftment, providing a safer and more controlled alternative to live stem cell transplantation.
Our study focused on dystrophic EB (DEB), the most severe form, where loss of collagen VII disrupts anchoring fibrils and dermal-epidermal adhesion. This pathology makes DEB an appropriate target for regenerative therapies such as mesenchymal stem cell-derived EVs and investigates if EVs from MSCs are safe and effective for treating DEB. It will examine how well these exosomes help heal wounds and promote tissue regeneration, hoping to find a new biological treatment option for this challenging disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Ev.FV 1.0 x 1011 par/mlQualified patients who have confirmed chronic wounds (10-50cm2) are included in the study after completing the consent form |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ev.FV 1.0 x 1011 par/mlEv.FV 1.0 x 1011 par/ml, IV, Total of 6 doses every 2weeks | Biological | Treatment |
Primary outcome
Rate of wound closure
Time frame: Day 14
percentage reduction in wound area compared to baseline, assessed by digital planimetry
EBDASI
Time frame: Day 14, 28, month 3 and month 6
EBDASI: epidermolysis bullosa disease activity and scarring index; measured in percentage change to baseline score,
1 secondary outcome
pain score (VAS Scale)
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Masoud Soleimani, Prof study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ev.FV 1.0 x 1011 par/ml in people with Dystrophic Epidermolysis Bullosa and Wound Heal, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Dehghani, Dr (36202020 ext. 031, l_dehghani2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of wound closure (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.