An interventional study of Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs) and Cross-linked Hyaluronic Acid (Synovian) in Osteoarthritis, Knee and Knee Osteoarthritis, sponsored by Yonsei University. Recruiting at 3 sites in South Korea. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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.
Osteoarthritis (OA) is a prevalent degenerative joint disease characterized by progressive loss of articular cartilage, chronic pain, and joint dysfunction. Autologous adipose-derived mesenchymal stem cells (ADMSCs) offer potential cartilage protective and anti-inflammatory properties. In this confirmatory trial, 165 eligible adults aged 40 to 70 years with radiographic KL grade II or III knee OA and persistent pain (VAS >= 40 mm) will undergo abdominal fat harvest. Participants will be randomized 2:1 to receive either an ultrasound-guided intra-articular injection of autologous ADMSCs (1.0 x 10\^8 cells suspended in 3 mL CryoStor 10) or high molecular weight cross-linked hyaluronic acid (Synovian 3 mL). Follow-up visits occur at 1, 3, and 6 months post-injection. The primary endpoint is the change from baseline in the WOMAC total score at 6 months. Secondary endpoints include changes in WOMAC subscales, VAS pain, KOOS subscores, responder rates (OMERACT-OARSI and MCID), structural outcomes on MRI (MOCART 2.0, MOAKS) and X-ray, rescue medication usage, exploratory synovial/serum biomarkers (COMP, CTX-II), and comprehensive safety profiles through 6 months. After completing the 6-month evaluation, participants allocated to the control group are offered autologous ADMSC injection.
3,407 studies on the registry are indexed under Osteoarthritis, Knee; 638 are open to participants now.
This study's planned enrollment of 165 is above the median of 69 across 2,822 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Yonsei University is the lead sponsor of 1,417 studies on the registry; 240 are open to participants now.
Compared within Osteoarthritis, Knee, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteoarthritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Arm Description: Participants receive a single ultrasound-guided intra-articular injection of autologous adipose-derived mesenchymal stem cells (1.0 x 10\^8 cells/3 mL CryoStor 10) isolated and culture-expanded from the participant's abdominal subcutaneous adipose tissue.
Biological: Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)
Participants undergo identical abdominal liposuction and receive a single ultrasound-guided intra-articular injection of high-molecular-weight cross-linked hyaluronic acid (Synovian 3 mL). At the completion of the 6-month study period, cross-over autologous ADMSC injection is provided.
Drug: Cross-linked Hyaluronic Acid (Synovian)
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.
Also known as: ADMSCs, Autologous Adipose-derived Stem Cells, ADSC Intra-articular Injection
Single intra-articular injection of 3 mL high molecular weight cross-linked hyaluronic acid (Synovian Inj., LG Chem) administered under ultrasound guidance.
Also known as: Synovian, High molecular weight crosslinked HA, Hyaluronic Acid
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 6 Months
The WOMAC total score assesses pain, stiffness, and physical function on a standardized scale. Higher scores indicate worse pain and functional limitation. The primary efficacy endpoint is the between-group difference in the change from baseline to 6 months post-injection, analyzed using analysis of covariance (ANCOVA).
Time frame: Baseline and 6 months post-injection
Change from Baseline in WOMAC Subscale Scores
Changes in individual WOMAC subscales: pain (5 items), stiffness (2 items), and physical function (17 items).
Time frame: Baseline, 1, 3, and 6 months post-injection
Change from Baseline in Visual Analog Scale (VAS) Pain Score
Knee pain assessed on a 100-mm Visual Analog Scale (VAS, 0 = no pain, 100 = worst pain).
Time frame: Baseline, 1, 3, and 6 months post-injection
Change from Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscores
Changes in KOOS subscales (Pain, Symptoms, ADL, Sport/Rec, and QOL; each scored 0-100, where 100 represents no symptoms/best function).
Time frame: Baseline, 1, 3, and 6 months post-injection
Proportion of Clinical Responders (MCID and OMERACT-OARSI criteria)
Responder rates evaluated by minimal clinically important difference (MCID: WOMAC \>= 9-point reduction, VAS \>= 14-mm reduction) and OMERACT-OARSI criteria.
Time frame: 6 months post-injection
Magnetic Resonance Imaging (MRI) Assessment of Cartilage
Evaluation of articular cartilage morphologic repair and progression using MOCART 2.0 (Magnetic Resonance Observation of Cartilage Repair Tissue) and MOAKS (MRI Osteoarthritis Knee Score).
Time frame: Baseline and 6 months post-injection
Radiographic Progression on Plain Radiographs (X-ray)
Changes in Kellgren-Lawrence (KL) grade and Hip-Knee-Ankle (HKA) mechanical alignment angle.
Time frame: Baseline, 3 months, and 6 months post-injection
Rescue Medication Usage
Proportion of participants requiring rescue medication (acetaminophen), cumulative tablet count, and days of rescue medication intake.
Time frame: Throughout the 6-month study period
Incidence and Severity of Adverse Events
Incidence, severity, and causality of all adverse events (AEs), serious adverse events (SAEs), and local injection-site reactions according to NCI-CTCAE v6.0 and WHO-UMC criteria.
Time frame: Throughout the 6-month study period
Plan to share: Undecided — The plan to share individual participant data with other researchers has not yet been determined.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Autologous adipose derived mesenchymal stem cells (mscs)