A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03183648

Enrollment

Registered

2017-06-12

Start date

2016-08-29

Completion date

2023-06-30

Last updated

2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Brief summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Detailed description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) 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.

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201. 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

1\. Subjects who are considered not suitable for the study by the principal investigator.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	up to 24 months	Evaluation of AE

Secondary

Measure	Time frame	Description
Vancouver Burn Scar Scale	Every time of visit for follow up to 24 weeks	Evaluation of Vancouver Burn Scar Scale

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026