NCT02674399

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

A Phase 2, Double-Blind, Randomized, Controlled Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Treatment of Osteoarthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Nature Cell Co. Ltd. · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blind, randomized, controlled study with two arms to evaluate JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 30 subjects will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.Only subjects who are assigned will be requested to visit the study center for 9-month and 12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all subjects who complete Visit 6 will be requested to visit the study center at 24-month after the injection.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	JointStem
DRUG	Synvisc-One

Timeline

• Start date: 2016-02-16
• Primary completion: 2018-03-12
• Completion: 2018-12-28
• First posted: 2016-02-04
• Last updated: 2021-08-10
• Results posted: 2021-07-13

Locations

2 sites across 1 country: United States