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Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Sponsor: Yonsei University
Summary
This multicenter, prospective, randomized, active-controlled, single-blind (assessor-blinded) clinical trial aims to evaluate the efficacy and safety of intra-articular injection of autologous adipose-derived mesenchymal stem cells (ADMSCs) compared with active comparator hyaluronic acid (HA) in patients with Kellgren-Lawrence grade II to III knee osteoarthritis. A total of 165 participants across 3 centers (Severance Hospital, Seoul National University Hospital, Inha University Hospital) will be randomly allocated to either the ADMSC group (1.0 x 10\^8 cells, single injection) or the HA group (Synovian, 3 mL) in a 2:1 ratio and followed for 6 months post-injection.
Official title: Efficacy and Safety of Intra-articular Autologous Adipose-Derived Mesenchymal Stem Cell Injections for Improving Clinical Function in Patients With Knee Osteoarthritis: A Multicenter, Prospective, Randomized, Active-Controlled Trial
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
165
Start Date
2026-09-03
Completion Date
2028-05-31
Last Updated
2026-10-28
Healthy Volunteers
No
Conditions
Interventions
Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)
Single intra-articular injection of 1.0 x 10\^8 culture-expanded autologous ADMSCs suspended in 3 mL cryopreservation medium (CryoStor 10) under ultrasound guidance.
Cross-linked Hyaluronic Acid (Synovian)
Single intra-articular injection of 3 mL high molecular weight cross-linked hyaluronic acid (Synovian Inj., LG Chem) administered under ultrasound guidance.
Locations (3)
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea