NCT04368806 · Nature Cell Co. Ltd.
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
What this study is about
This study is a where neither patients nor doctors know which treatment is given, randomly assigned, placebo controlled, multi-center, superiority study to evaluate the effectiveness and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis.
View original scientific description
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo).
Interventions
DRUG
JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
OTHER
Placebo Control
Normal Saline with autologous Serum
Primary outcome measures
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Time frame: Baseline and Week 48
Change from baseline in WOMAC function score at Week 48
Visual Analog Scale (VAS) score
Time frame: Baseline and Week 48
Change from baseline on Visual Analog Scale (VAS) score at Week 48
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \> 1. Male or female of any race, adult aged 18 years or older 2. Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria) 3. Subject who has ≥ 45 on WOMAC function score at Screening and Baseline 4. Subject who has knee pain ≥ 70 mm for the study knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline 5. Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria 6. Subject who has a varus angle of 5 degrees or less confirmed through radiography 7. Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to Screening and does not improve symptoms with non-operative treatment options 8. Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (acetaminophen \< 3.25 g per day) at least 72 hours prior to Screening and throughout the duratio
Where
- El Cajon, California
- La Mesa, California
- Napa, California
- Newport Beach, California
- Santa Monica, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations