Autologous adipose-derived stem cell injections for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, single-blind study compares intra-articular injections of autologous adipose-derived mesenchymal stem cells to hyaluronic acid in adults with Kellgren-Lawrence grade II–III knee osteoarthritis. Seventy-five participants receive the stem cell treatment and 150 receive hyaluronic acid, with follow-up visits at 1, 3, and 6 months to assess pain, function, and structural outcomes. Primary endpoint is change in the WOMAC total score at 6 months; secondary endpoints include MRI/MRI-based structural assessments, biomarker analyses, and safety. Eligible participants will undergo abdominal fat harvest to obtain autologous cells, with one-time injection performed under ultrasound guidance. After 6 months, those in the control group may opt to receive autologous stem cell treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 40 to 70 years at the time of written informed consent.
2. Knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) criteria with persistent knee pain for at least 3 months.
3. Radiographic Kellgren-Lawrence (KL) grade II or grade III in the target knee.
4. Activity pain score of \>= 40 mm on a 100-mm Visual Analog Scale (VAS) in the target knee.
5. 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).
6. Voluntary provision of written informed consent.

Exclusion Criteria:

1. Secondary knee osteoarthritis caused by infection, rheumatoid arthritis, or inflammatory joint disease.
2. Pain caused by meniscus posterior horn root tear within 3 months prior to screening.
3. Pain judged to be caused by subchondral insufficiency fracture or osteonecrosis.
4. Conditions affecting joint pain or prognosis (e.g., gout, pseudogout, periarticular fracture, hemochromatosis, Wilson's disease, hypermobility, collagen gene disorders).
5. Body Mass Index (BMI) \>= 35 kg/m2.
6. 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).
7. 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.
8. Uncontrolled type 1 or type 2 diabetes (HbA1c \> 8.5% at screening).
9. Positive test for Human Immunodeficiency Virus (HIV) antibody.
10. History of malignant neoplasm within 3 years prior to screening.
11. Participation in another clinical trial within 60 days prior to screening.
12. Clinically significant abnormal screening laboratory findings.
13. Psychiatric disorder, alcohol/drug abuse affecting adherence or safety.
14. Pregnant or breastfeeding women.
15. Women of childbearing potential or men unwilling to use medically acceptable contraception during the trial.
16. Judged ineligible by the investigator.

Where it's running

• Inha University Hospital
  Incheon, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sung-Hwan Kim, M.D., Ph.D.
• Email: orthohwan@gmail.com
• Phone: +82-2-2228-5679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.