Skip to main content
Clinical Trials/NCT03183934
NCT03183934CompletedNot Applicable

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

Anterogen Co., Ltd.1 site in 1 country2 target enrollmentStarted: December 8, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2
Locations
1
Primary Endpoint
Safety assessed by clinically measured abnormality of laboratory tests and adverse events

Study Overview

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Outcomes

Primary Outcomes

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

  • Area of re-epithelization(Every time of visit for follow up to 24 months)

Investigators

Sponsor
Anterogen Co., Ltd.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials