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CompletedNCT03183622Updated Jan 10, 2018

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-101 Clinical Trial

An observational study in Burn, sponsored by Anterogen Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-10.

Sponsored by Anterogen Co., Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
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Study summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial(ALLO-ASC-BI-101) for 23 months.

Read the detailed description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-BI-101) for 23 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 burn.

02

Conditions studied

  • Burn

Keywords

  • Deep Second-Degree Burn Wound
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In context

Lead sponsor

Anterogen Co., Ltd. is the lead sponsor of 30 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-BI-101

Inclusion criteria

  1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-BI-101.
  2. 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.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who are considered not suitable for the study by the principal investigator. (For example, Subjects requiring surgical procedure on target site)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • ALLO-ASC-DFU treatment

    Subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial of ALLO-ASC-BI-101

    Biological: ALLO-ASC-DFU

Interventions

  • BiologicalALLO-ASC-DFU

    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 burn. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

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What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Evaluation of AE

    Time frame: up to 24 months

Secondary outcomes

  1. Vancouver Burn Scar Scale

    Evaluation of Vancouver Burn Scar Scale

    Time frame: Every time of visit for follow up to 24 months

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Study locations

1 site
  • Hallym university Medical Center
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03183622
Lead sponsor
Anterogen Co., Ltd.
Responsible party
Sponsor
First posted
Jun 12, 2017
Start date
Nov 2015
Primary completion
Jul 2017
Completion
Dec 2017
Last update
Jan 10, 2018

Study contacts

Wook Chun, PhD
principal investigator · Hallym University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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