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A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-BI-201 Clinical Trial

Sponsor
Anterogen Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03183648
Collaborator
(none)
30
Enrollment
1
Location
82
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) for 23 months.

Condition or Disease Intervention/Treatment Phase
  • Biological: ALLO-ASC-DFU

Detailed Description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-BI-201) 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-BI-201
Actual Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 24 months]

    Evaluation of AE

Secondary Outcome Measures

  1. Vancouver Burn Scar Scale [Every time of visit for follow up to 24 weeks]

    Evaluation of Vancouver Burn Scar Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-BI-201.

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hallym university Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Anterogen Co., Ltd.

Investigators

  • Principal Investigator: Wook Chun, PhD, Hallym University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anterogen Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03183648
Other Study ID Numbers:
  • ALLO-ASC-BI-202
First Posted:
Jun 12, 2017
Last Update Posted:
Jul 21, 2021
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 21, 2021