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

NCT03183934 | Completed

• 1 other identifier: ALLO-ASC-EB-102
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dystrophic Epidermolysis Bullosa

Keywords

Epidermolysis Bullosa; Stem cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Area of re-epithelization

  Every time of visit for follow up to 24 months

Interventions

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

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subject is enrolled who are treated with ALLO-ASC-DFU sheet in phase 1/2 clinical trial of ALLO-ASC-EB-101

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Gangnam Severence Hospital

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Skin Diseases, Vesiculobullous

Study Officials

• Su Chan Kim, PhD

  Gangnam Severence Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: December 8, 2017
• Primary Completion: April 20, 2018
• Study Completion: April 30, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)