Clinical trial

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

Name

ALLO-ASC-BI-202

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.

Trial arms

Trial start

2016-08-29

Estimated PCD

2020-04-02

Trial end

2023-06-01

Status

Completed

Treatment

ALLO-ASC-DFU

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. This tudy is a follow-up study without intervention. Other Names: Allogenic adipose-derived mesenchymal stem cells

Size

Primary endpoint

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

up to 24 months

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

Updated at

2023-08-25

1 organization

1 product

1 indication

Organization

Anterogen

Product

ALLO-ASC-DFU

Indication

Burn