Burn Clinical Trial
Official title:
A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1 Clinical Trial of ALLO-ASC-BI-101
Verified date | January 2018 |
Source | Anterogen Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial(ALLO-ASC-BI-101) for 23 months.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-BI-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. (For example, Subjects requiring surgical procedure on target site) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym university Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Anterogen Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Evaluation of AE | up to 24 months | |
Secondary | Vancouver Burn Scar Scale | Evaluation of Vancouver Burn Scar Scale | Every time of visit for follow up to 24 months |
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