A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis (NCT04368806)
A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: TriWest Research Associates — El Cajon, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- TriWest Research Associates — El Cajon, California
- BioSolutions Clinical Research Center — La Mesa, California
- Neurovations Research — Napa, California
- Newport Therapeutics — Newport Beach, California
- Source Healthcare — Santa Monica, California
- Keimyung University Dongsan Hospital — Daegu, Korea
- Kyung Hee University Medical Center — Seoul, Korea
- Kyung Hee University Hospital At Gangdong — Seoul, Korea
- Smg-Snu Boramae Medical Center — Seoul, Korea
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteoarthritis, Knee
- The Impact of Procedural Awareness of Knee Injections for Osteoarthritis on Patient Perceptions of Effectiveness — Hamilton, Ontario
- Genicular Radiofrequency Ablation Following Total Knee Arthroplasty — Calgary, Alberta
- Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis — Sacramento, California
- Treatment Effects of Subcutaneous Injections of Pentosan Polysulfate Sodium vs Placebo in Participants With Knee OA Pain — Tempe, Arizona
- Prospective Randomized Study of Cementless vs Cemented UKA — New Albany, Ohio
- Clinical Outcomes of Joint Arthroplasty — St. Helena, California
Explore by condition: All Osteoarthritis, Knee clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.