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

NCT ID: NCT03183622

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Burn

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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ALLO-ASC-DFU treatment

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

ALLO-ASC-DFU

Intervention Type BIOLOGICAL

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

Interventions

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ALLO-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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anterogen Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wook Chun, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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Hallym university Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ALLO-ASC-BI-102

Identifier Type: -

Identifier Source: org_study_id

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