Clinical trial NCT06141811: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Official title: A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 104
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ubjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.

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-302) 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-302) 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-302.
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: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Bucheon ST. Mary's Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Borame Medical Center
Study officials:
affiliation: Asan Medical Center
name: ChangSik Park, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Borame Medical Center
name: JiUng Bak, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon St. Mary's Hospital
name: DaeWon Jun, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: YoungKoo Lee, MD. Ph D
role: PRINCIPAL_INVESTIGATOR
References: