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NCT Number: NCT03183934

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

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.

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Key information

Conditions

Dystrophic Epidermolysis Bullosa Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

2 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severence Hospital

Seoul, 135-720, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Safety assessed by clinically measured abnormality of laboratory tests and adverse events

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

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

Secondary outcomes

  1. Area of re-epithelization

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

    Time taken to re-epithelization

Sponsors and collaborators

Lead sponsor

Anterogen Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2023
First posted
Jun 12, 2017
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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