Clinical trial NCT04590703: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial
Official title: A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 3 Clinical Trial of ALLO-ASC-DFU-301
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.

Brief summary: This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) for 24 months

Detailed description: This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-301) 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 Diabetic Foot Ulcer.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-301.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of systemic tolerance through incidence of abnormal laboratory test results
timeFrame: Up to 9 months
measure: Evaluation of incidence of clinically significant change in physical examination and vital signs
timeFrame: Up to 18 months
measure: Evaluation of localized tolerance through incidence of clinically significant change about treatment area
timeFrame: Up to 24 months
measure: Evaluation of incidence of adverse events
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungcheongnam-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: SeungKyu Han, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nowon Eulji Medical Center, Eulji University
name: KiWon Young, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: JunPyo Hong, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: JunHyeong Kim, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Chan Kang, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Medical Center
name: HyungMin Hahn, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: ChanYeong Heo, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: YoungKoo Lee, MD. Ph D.
role: PRINCIPAL_INVESTIGATOR
References: