Actively Recruiting
A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Knee Osteoarthritis
Led by Nature Cell Co. Ltd. · Updated on 2025-07-24
140
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of JointStem, an autologous adipose tissue derived mesenchymal stem cell (AdMSC) treatment, in patients diagnosed with knee osteoarthritis. This double-blind, randomized, placebo-controlled, multi-center study aims to compare JointStem with a placebo to determine its benefit for knee osteoarthritis symptoms and function over nearly one year. Participants will be randomly assigned to receive either JointStem or a placebo consisting of normal saline with autologous serum. The study includes a screening period, baseline visit with lipoaspiration to collect fat tissue, treatment by intra-articular injection, and follow-up visits at 4, 12, 24, 36, and 48 weeks after treatment. After the 48-week visit, the study data will be reviewed and unblinded for analysis. During the study, participants will undergo assessments including the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function and pain scores, Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC) score, and health surveys. Radiographic evaluations and tracking of rescue medication use will also be conducted. Participants will be monitored regularly through scheduled visits over 48 weeks to assess treatment effects and safety.
CONDITIONS
Brief 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 adult 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 score of 70 mm or more on a 100 mm Visual Analog Scale at screening and baseline
- Radiographic evidence of grade 3 osteoarthritis based on Kellgren and Lawrence criteria
- Varus knee angle of 5 degrees or less confirmed by radiography
- Knee pain persisting for at least 12 weeks prior to screening without improvement from non-operative treatments
- Willing to stop all osteoarthritis pain medications except rescue 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) greater than 35 kg/m2
- History of uncontrolled or clinically significant diseases affecting study participation (e.g., kidney, liver, endocrine diseases)
- Autoimmune diseases or specific joint disorders such as rheumatoid inflammation, septic arthritis, gout, or others listed
- History or current treatment for cancer
- Positive for HIV, viral hepatitis, or syphilis
- Heart disease or history of serious heart conditions within 6 months before screening
- Received intra-articular therapy or knee surgery within 6 months before screening
- History of prolotherapy or platelet rich plasma injection within 6 months before screening
- Received long-acting hyaluronic acid injection within 6 months before screening
- Prior stem cell therapy
- Significant lab abnormalities in liver enzymes, kidney function, blood clotting, hemoglobin, or platelets
- Potential issues with lipoaspiration as judged by investigator
- History of local anesthetic allergy
- Taken anti-inflammatory or steroid medications within 14 days before screening without completing wash-out
- Active drug or alcohol abuse
- Pregnant or breastfeeding, or not using effective contraception
- Participation in other clinical trials within 3 months before screening
- Received COVID-19 vaccine within 1 week before baseline visit
- Any other reason deemed inappropriate by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo baseline assessments and randomization, including lipoaspiration procedure before treatment.
1 visit (in-person)
Duration - Single day
Participants receive an intra-articular injection of JointStem or placebo.
1 visit (in-person)
Duration - 48 weeks
Participants are monitored for safety and efficacy through scheduled assessments after treatment.
5 visits (at Weeks 4, 12, 24, 36, and 48; in-person)
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
C
Christine Lee
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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