A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Osteoarthritis, Knee
In brief
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.
Key facts
- Study ID
- NCT04368806
- Run by
- Nature Cell Co. Ltd.
- People needed
- 173
- Starts
- 2021-05-26
- Expected to finish
- 2027-08-07
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- TriWest Research Associates — El Cajon, California, United States
- BioSolutions Clinical Research Center — La Mesa, California, United States
- Neurovations Research — Napa, California, United States
- Newport Therapeutics — Newport Beach, California, United States
- Source Healthcare — Santa Monica, California, United States
- Keimyung University Dongsan Hospital — Daegu, Korea, South Korea
- Kyung Hee University Medical Center — Seoul, Korea, South Korea
- Kyung Hee University Hospital At Gangdong — Seoul, Korea, South Korea
- Smg-Snu Boramae Medical Center — Seoul, Korea, South Korea
Full record on ClinicalTrials.gov
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