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RECRUITING
NCT07901790
NA

Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

Sponsor: Yonsei University

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

DRUG

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