Burn InjuryPhase 2NCT02619851
A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects
A Phase 2 study testing ALLO-ASC-DFU and Conventional Therapy in people with Burn Injury, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Injury
- What is being tested?
- ALLO-ASC-DFU and Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2015to 13 Jul 2021
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age and older.
- Subjects who have deep second-degree burn wound ≥100cm^2.
- TBSA(Total burn surface area) ≤ 30%
- Negative for Urine beta-HCG for women of childbearing age.
- Subject is able to give written informed consent prior to study start and comply with the study requirements.
Who cannot join
- Subject who have been enrolled in another clinical study within 30 days of screening.
- Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
- Subjects with active infection.
- Subjects with hemorrhagic and hemocoagulative disease.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
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- Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
- Subjects who are pregnant or breast-feeding.
- Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
- Burn wound is present on any part of the face.
- Subjects who are considered not suitable for the study by the investigator.
- Subjects who are not able to understand the objective of this study or to comply with the study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter
This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.
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 a new option in treating Deep Second-degree burn wounds.
- Conditions
- Burn Injury
- Being tested
- ALLO-ASC-DFU, Conventional Therapy
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASC-DFUBiological
Also called Allogeneic mesenchymal stem cells
Dressing for Second Deep degree Burn injury
Conventional TherapyDevice
Typical therapy conducted for burn injury patients
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Allogeneic mesenchymal stem cells Receives: Biological: ALLO-ASC-DFU |
| Conventional Therapy | Active comparator | Typical therapy conducted for burn injury patients Receives: Device: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of re-epithelialization
Time of re-epithelialization
Measured: Follow up to 12 weeks
Secondary outcomes (3)
Safety (laboratory tests and adverse events)
Clinically measured abnormality of laboratory tests and adverse events
Measured: Follow up to 12 weeks
Burn Scar Index
Vancouver Burn Scar Scale
Measured: Follow up to 12 weeks
healing status of the wound evidenced by photography
healing status of the wound evidenced by photography
Measured: follow up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start23 Dec 2015
- Primary completion2 Jul 2019
- Study completion13 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wook Chun, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619851
- Sponsor's protocol ID
- ALLO-ASC-BI-201
- Status last verified
- Aug 2023
- First submitted
- 30 Nov 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 II Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects: Controlled, Parallel, Multicenter
- ClinicalTrials.gov ID
- NCT02619851
- Acronym / sponsor ID
- ALLO-ASC-BI-201
- Conditions
- Burn Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2015 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 2 Dec 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 clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.
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 a new option in treating Deep Second-degree burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Biological: ALLO-ASC-DFUAllogeneic mesenchymal stem cells |
| Conventional Therapy | Active comparator | Device: Conventional TherapyTypical therapy conducted for burn injury patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 years of age and older.
- Subjects who have deep second-degree burn wound ≥100cm^2.
- TBSA(Total burn surface area) ≤ 30%
- Negative for Urine beta-HCG for women of childbearing age.
- Subject is able to give written informed consent prior to study start and comply with the study requirements.
Key exclusion criteria (12 listed)
- Subject who have been enrolled in another clinical study within 30 days of screening.
- Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
- Subjects with active infection.
- Subjects with hemorrhagic and hemocoagulative disease.
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-DFUAlso: Allogeneic mesenchymal stem cellsDressing for Second Deep degree Burn injury | Biological | ALLO-ASC-DFU |
| Conventional TherapyTypical therapy conducted for burn injury patients | Device | Conventional Therapy |
Primary outcome
Time of re-epithelialization
Time frame: Follow up to 12 weeks
Time of re-epithelialization
3 secondary outcomes
Safety (laboratory tests and adverse events)
Time frame: Follow up to 12 weeks
Burn Scar Index
Time frame: Follow up to 12 weeks
healing status of the wound evidenced by photography
Time frame: follow up to 12 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.
Wook Chun, MD, PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLO-ASC-DFU and Conventional Therapy in people with Burn Injury, 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 12 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 phase mean?
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?
Time of re-epithelialization (time frame: Follow up to 12 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.