NCT04368806

A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Nature Cell Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Study Procedures: * Visit 1 (Week -7) - Screening * Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration) * Visit 3 (Week 0) - Treatment (Intra-articular injection) * Visit 4 (Week 4) - 4 weeks follow-up * Visit 5 (Week 12) - 12 weeks follow-up * Visit 6 (Week 24) - 24 weeks follow-up * Visit 7 (Week 36) - 36 weeks follow-up * Visit 8 (Week 48) - 48 weeks follow-up (End of Study)

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	JointStem	Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
OTHER	Placebo Control	Normal Saline with autologous Serum

Timeline

• Start date: 2021-05-26
• Primary completion: 2026-12-30
• Completion: 2026-12-31
• First posted: 2020-04-30
• Last updated: 2025-07-24

Locations

9 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study