Dystrophic Epidermolysis BullosaPhase 1/2NCT02579369
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
A Phase 1/2 study testing Allogeneic mesenchymal stem cells and Polyurethene Film in people with Dystrophic Epidermolysis Bullosa, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Dystrophic Epidermolysis Bullosa
- What is being tested?
- Allogeneic mesenchymal stem cells and Polyurethene Film
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2015to 30 Apr 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age : 10~60
- Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
- Bullous skin lesion sized over 10 cm^2
- Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
- A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.
Who cannot join
- A subject with history of epidermoid carcinoma within a year from screening.
- A subject who requires antibiotics due to bacterial infection on skin.
- A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
- A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
- A subject treated with steroids locally, within 30 days prior to screening.
- A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
Show all 17Show fewer
- A subject with 2-times the maximum-standardized value of BUN, Creatinine
- A subject with Albumin below 2.0 g/dL.
- A subject with Hemoglobin below 6 g/dL (anemic).
- A subject with allergic response to bovine derived protein and fibrin glue.
- A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
- A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
- A subject who enrolled into another clinical trial, within 30 days prior to screening
- A subject with serious disease that can affect on clinical trial.
- A pregnant or breast-feeding subject.
- A subject with history of drug abuse within 1 year of clinical significance
- A subject who cannot proceed according to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
Read the detailed description
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.
- Conditions
- Dystrophic Epidermolysis Bullosa
- Being tested
- Allogeneic mesenchymal stem cells, Polyurethene Film
- Keywords
- Epidermolysis Bullosa, stem cell
- Medical subject headings
- Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic mesenchymal stem cellsOther
Also called ALLO-ASC-DFU
Dressing for Dystrophic Epidermolysis Bullosa wound.
Polyurethene FilmDevice
Dressing for Dystrophic Epidermolysis Bullosa wound.
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Not described Receives: Other: Allogeneic mesenchymal stem cells |
| Conventional Therapy | Active comparator | Not described Receives: Device: Polyurethene Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of re-epithelization
Measured: Follow up to 8 weeks
Secondary outcomes (3)
Percentage of a target wound's re-epithelialization
Measured: Every time of visit for follow up to 8 weeks
Time taken to re-epithelization
Measured: Over 8 weeks
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Measured: Over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start8 Dec 2015
- Primary completion1 Apr 2016
- Study completion30 Apr 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Su Chan Kim, PhD., Principal investigator, Gangnam Severence Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579369
- Sponsor's protocol ID
- ALLO-ASC-EB-101
- Status last verified
- Aug 2023
- First submitted
- 16 Oct 2015
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa
- ClinicalTrials.gov ID
- NCT02579369
- Acronym / sponsor ID
- ALLO-ASC-EB-101
- Conditions
- Dystrophic Epidermolysis Bullosa
- Keywords
- Epidermolysis Bullosa, stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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.
This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.
Detailed description
ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Other: Allogeneic mesenchymal stem cells |
| Conventional Therapy | Active comparator | Device: Polyurethene Film |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age : 10~60
- Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
- Bullous skin lesion sized over 10 cm^2
- Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
- A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.
Key exclusion criteria (17 listed)
- A subject with history of epidermoid carcinoma within a year from screening.
- A subject who requires antibiotics due to bacterial infection on skin.
- A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
- A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
- A subject treated with steroids locally, within 30 days prior to screening.
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 |
|---|---|---|
| Allogeneic mesenchymal stem cellsAlso: ALLO-ASC-DFUDressing for Dystrophic Epidermolysis Bullosa wound. | Other | ALLO-ASC-DFU |
| Polyurethene FilmDressing for Dystrophic Epidermolysis Bullosa wound. | Device | Conventional Therapy |
Primary outcome
Area of re-epithelization
Time frame: Follow up to 8 weeks
3 secondary outcomes
Percentage of a target wound's re-epithelialization
Time frame: Every time of visit for follow up to 8 weeks
Time taken to re-epithelization
Time frame: Over 8 weeks
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time frame: Over 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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. This study is not recruiting at the moment.
Su Chan Kim, PhD. principal investigator
Gangnam Severence Hospital
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 Allogeneic mesenchymal stem cells and Polyurethene Film in people with Dystrophic Epidermolysis Bullosa, run by Anterogen Co., Ltd. at 1 site in South Korea.
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 5 inclusion and 17 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: finished, as of the sponsor's last update on 25 Aug 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of re-epithelization (time frame: Follow up to 8 weeks). 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 25 Aug 2023.