Dystrophic Epidermolysis BullosaNCT03183934
A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical Trial
An observational study of Dystrophic Epidermolysis Bullosa, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Dystrophic Epidermolysis Bullosa
- What is being tested?
- ALLO-ASC-DFU
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Dec 2017to 30 Apr 2023
- Phase
- Observational
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101
Who may be able to join
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.
- A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.
Who cannot join
- 1. Subjects who are considered not suitable for the study by the principal investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.
Read the detailed description
This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.
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 a new option in treating a Dystrophic Epidermolysis Bullosa.
- Conditions
- Dystrophic Epidermolysis Bullosa
- Being tested
- ALLO-ASC-DFU
- 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.
ALLO-ASC-DFUBiological
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 a new option in treating a Dystrophic Epidermolysis Bullosa.
This study is a follow-up study without intervention.
Other Names:
Allogenic adipose-derived mesenchymal stem cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: Every time of visit for follow up to 24 months
Secondary outcomes (1)
Area of re-epithelization
Time taken to re-epithelization
Measured: Every time of visit for follow up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start8 Dec 2017
- Primary completion20 Apr 2018
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- 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
- NCT03183934
- Sponsor's protocol ID
- ALLO-ASC-EB-102
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2017
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101
- ClinicalTrials.gov ID
- NCT03183934
- Acronym / sponsor ID
- ALLO-ASC-EB-102
- Conditions
- Dystrophic Epidermolysis Bullosa
- Keywords
- Epidermolysis Bullosa, Stem cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 12 Jun 2017 (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.
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial(ALLO-ASC-EB-101) for 24 months.
Detailed description
This is an open-label follow up study to evaluate the efficacy and safety for the subjects with ALLO-ASC-DFU treatment in phase 1/2 clinical trial (ALLO-ASC-EB-101) for 24 months.
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 a new option in treating a Dystrophic Epidermolysis Bullosa.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101
Key inclusion criteria (2 listed)
- Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101.
- A subject who is willing to follow the protocol and provide informed consent on screening, given that the information with respect to the clinical trial is provided.
Key exclusion criteria (1 listed)
- 1. Subjects who are considered not suitable for the study by the principal investigator.
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 |
|---|---|---|
| ALLO-ASC-DFUALLO-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 a new option in treating a Dystrophic Epidermolysis Bullosa. This study is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells | Biological | – |
Primary outcome
Safety assessed by clinically measured abnormality of laboratory tests and adverse events
Time frame: Every time of visit for follow up to 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
1 secondary outcome
Area of re-epithelization
Time frame: Every time of visit for follow up to 24 months
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.
- Individual participant dataSharing planned: No
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Enrolling by invitationObservational study
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RDEB
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?
An observational study of 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 2 inclusion and 1 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.
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?
Safety assessed by clinically measured abnormality of laboratory tests and adverse events (time frame: Every time of visit for follow up to 24 months). 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.