Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Key facts
- Who runs it
- Yonsei University
- Where
- South Korea3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 165 people, planned
- Started
- 3 Sept 2026
- Expected to end
- 31 May 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)
- Cross-linked Hyaluronic Acid (Synovian)
- Record updated
- 28 October 2026
Who can take part
- Age
- 40 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Adults aged 40 to 70 years at the time of written informed consent
- Knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) criteria with persistent knee pain for at least 3 months
- Radiographic Kellgren-Lawrence (KL) grade II or grade III in the target knee
- Activity pain score of >= 40 mm on a 100-mm Visual Analog Scale (VAS) in the target knee
- Unilateral or bilateral knee OA. In bilateral cases, one target knee must be designated according to criteria 1-4 (if both knees meet criteria, the more painful/symptomatic knee is selected)
- Voluntary provision of written informed consent
Who cannot take part
- Pain caused by meniscus posterior horn root tear within 3 months prior to screening
- Prior total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA) in the target knee (prior HTO or partial meniscectomy >= 6 months with stable status is permitted)
- Recent target knee treatments: cross-linked HA, cell therapy, or gene therapy within 6 months; linear HA or intra-articular corticosteroid within 3 months; oral NSAIDs, glucosamine, chondroitin, or oral steroids within 14 days prior to injection
- Participation in another clinical trial within 60 days prior to screening
- Secondary knee osteoarthritis caused by infection, rheumatoid arthritis, or inflammatory joint disease
- Pain judged to be caused by subchondral insufficiency fracture or osteonecrosis
- Conditions affecting joint pain or prognosis (e.g., gout, pseudogout, periarticular fracture, hemochromatosis, Wilson's disease, hypermobility, collagen gene disorders)
- Positive test for Human Immunodeficiency Virus (HIV) antibody
- History of malignant neoplasm within 3 years prior to screening
- Psychiatric disorder, alcohol/drug abuse affecting adherence or safety
- Uncontrolled type 1 or type 2 diabetes (HbA1c > 8.5% at screening)
- Clinically significant abnormal screening laboratory findings
- Body Mass Index (BMI) >= 35 kg/m2
- Pregnant or breastfeeding women
- Women of childbearing potential or men unwilling to use medically acceptable contraception during the trial
- Judged ineligible by the investigator
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Autologous ADMSC InjectionTreatment being tested
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.
Treatment: Autologous Adipose-Derived Mesenchymal Stem Cells (ADMSCs)
- Hyaluronic Acid InjectionExisting treatment, for comparison
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.
Treatment: Cross-linked Hyaluronic Acid (Synovian)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Fit questions
- Built from NCT07901790, who can take part
- Record updated
- 28 October 2026