Actively Recruiting
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
Led by Nature Cell Co. Ltd. · Updated on 2025-07-24
140
Participants Needed
9
Research Sites
292 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
CONDITIONS
Official Title
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 years or older
- Diagnosed with knee osteoarthritis according to clinical and American College of Rheumatology criteria
- WOMAC function score of 45 or higher at screening and baseline
- Knee pain of 70 mm or more out of 100 mm on Visual Analog Scale at screening and baseline
- Radiographic evidence of grade 3 knee osteoarthritis based on Kellgren and Lawrence criteria
- Varus angle of 5 degrees or less confirmed by X-ray
- Knee pain lasting at least 12 weeks prior to screening not improved by non-surgical treatments
- Willing to stop all pain medications except acetaminophen (less than 3.25 g per day) at least 72 hours before screening and during the study
- Able and willing to provide written informed consent
You will not qualify if you...
- Body mass index (BMI) over 35 kg/m2
- History of significant uncontrolled diseases (kidney, liver, endocrine, etc.) affecting study participation
- Presence of autoimmune diseases, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease
- Genetic diseases such as hyperkinesia or collagen gene abnormalities
- Inflammatory joint disorders like rheumatoid arthritis
- Infectious joint disorders such as septic arthritis
- Other joint disorders including gout, pseudogout, fractures, osteochondrosis, villonodular synovitis
- History of cancer or current cancer treatment
- Positive tests for HIV, viral hepatitis, or syphilis
- Heart diseases or history of heart disease within 6 months prior to screening
- Intra-articular therapy or knee surgery within 6 months prior to screening
- History of prolotherapy or platelet rich plasma injection within 6 months prior to screening
- Long-acting hyaluronic acid injection within 6 months prior to screening
- Prior stem cell therapy
- Significant abnormal lab results (e.g., liver enzymes, creatinine, blood counts)
- Unsuitable for lipoaspiration
- Allergy to local anesthetics
- Use of anti-inflammatory drugs, slow acting drugs, or steroids within 14 days prior to screening without washout
- Active drug or alcohol abuse
- Pregnant, breastfeeding, or not using appropriate contraception
- Participation in another clinical trial within 3 months
- Receipt of COVID-19 vaccine within 1 week prior to baseline
- Any other reason investigator deems inappropriate for study participation
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Trial Site Locations
Total: 9 locations
1
TriWest Research Associates
El Cajon, California, United States, 92020
Actively Recruiting
2
BioSolutions Clinical Research Center
La Mesa, California, United States, 91942
Actively Recruiting
3
Neurovations Research
Napa, California, United States, 94558
Actively Recruiting
4
Newport Therapeutics
Newport Beach, California, United States, 92660
Actively Recruiting
5
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
6
Keimyung University Dongsan Hospital
Daegu, Korea, South Korea, Republic of, 42601
Actively Recruiting
7
Kyung Hee University Medical Center
Seoul, Korea, South Korea, Republic of, 02447
Actively Recruiting
8
Kyung Hee University Hospital At Gangdong
Seoul, Korea, South Korea, Republic of, 05278
Actively Recruiting
9
Smg-Snu Boramae Medical Center
Seoul, Korea, South Korea, Republic of, 07061
Actively Recruiting
Research Team
H
Hugh Lee
CONTACT
C
Christine Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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