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NCT03183934 Clinical Trial

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

Dystrophic Epidermolysis Bullosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03183934
Other study ID # ALLO-ASC-EB-102
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 8, 2017
Est. completion date April 30, 2023

Study information
Verified date August 2023
Source Anterogen Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date April 30, 2023
Est. primary completion date April 20, 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 60 Years
Eligibility Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 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 Dystrophic Epidermolysis Bullosa. This study is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Locations
Country Name City State
Korea, Republic of Gangnam Severence Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Every time of visit for follow up to 24 months
Secondary Area of re-epithelization Time taken to re-epithelization Every time of visit for follow up to 24 months
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