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Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
Sponsor: Medipost Co Ltd.
Summary
This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2023-03-20
Completion Date
2027-11-30
Last Updated
2025-02-07
Healthy Volunteers
No
Conditions
Interventions
SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
High Hyal Plus
A single knee administration of Hyaluronic acid(1% Sodium Hyaluronate 20mg/2ml)
Locations (5)
Seoul Nation University Bundang Hospital
Gyeonggi-do, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea University Anam Hospita
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea