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JointStem for Knee Osteoarthritis

This study is testing a treatment called JointStem for people with knee osteoarthritis. JointStem uses your own fat cells (autologous adipose tissue derived mesenchymal stem cells) to help your knee. Researchers want to see if JointStem is safe and if it works better than a placebo (a treatment with no active medicine, in this case, normal saline with your own serum). You might be able to join if you are 18 or older, have knee osteoarthritis, and have a certain level of pain or difficulty with daily activities (measured by a WOMAC function score of 45 or higher). The study will look at your pain and function over 48 weeks to see if JointStem helps improve these areas. About 140 people will participate.

Study design
This is a double-blind, randomized, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving JointStem or the placebo. Approximately 140 participants will be randomly assigned to one of two groups.
What's involved
You would have a screening visit, a baseline visit where fat cells are collected, a treatment visit where you receive an injection, and then five follow-up visits over 48 weeks.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 48 weeks after your treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04368806

A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Nature Cell Co. Ltd.
~173 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:JointStemPlacebo Control

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Measured over Baseline and Week 48
+1 more outcome measured

Conditions

Osteoarthritis, Knee

Explore related trials

Osteoarthritis

Where it's being run

9 sites across 2 states
California5
Korea4

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Exclusion

Autoimmune diseases
Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
Inflammatory joint disorders (e.g., rheumatoid inflammation)
Infectious joint disorders (e.g., septic arthritis)
Other joint disorders (e.g., gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis) 4. Subject who has any history of cancer and/or currently receiving treatment for a current cancer diagnosis. 5. Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis) 6. Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening 7. Subject who has received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening 8. Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening 9. Subject who has received long-acting hyaluronic acid injection (e.g., Synvisc-One®, etc.) within 6 months prior to Screening 10. Subject who has history of stem cell therapy 11. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
Serum ALT and AST \> 2 x upper limit of normal
Serum creatinine out of normal range
PT/INR out of normal range
Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject
Platelets out of normal range 12. Subject for whom the investigator judges the lipoaspiration can cause any problem 13. Subject who has history of local anesthetic allergy 14. Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.) 15. Subject who is an active drug/alcohol abuser 16. Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method) 17. Subject who is enrolled in any other clinical trials within 3 months from screening 18. Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline) 19. Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above

What this trial measures

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) function ScoreBaseline and Week 48

    Change from baseline in WOMAC function score at Week 48

  • Visual Analog Scale (VAS) scoreBaseline and Week 48

    Change from baseline on Visual Analog Scale (VAS) score at Week 48