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NCT02674399 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
A Phase 2 study, sponsored by Nature Cell Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT02674399 is a Phase 2 study that has completed, run by Nature Cell Co.. The registered enrollment target is 28 participants.
The verdict
NCT02674399, a Phase 2 study, has completed, sponsored by Nature Cell Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DRUG JointStem
- DRUG Synvisc-One
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-02-16 |
| Est. Completion | 2018-12-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02674399
The ClinicalTrials.gov registry entry for NCT02674399 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nature Cell Co., which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which JointStem is the first listed.
NCT02674399 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02674399 about?
NCT02674399 is a clinical study titled "A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis". 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 ...
What is the current status of trial NCT02674399?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2016-02-16. Estimated completion is 2018-12-28.
What interventions are being tested in trial NCT02674399?
The interventions under investigation include: JointStem (DRUG), Synvisc-One (DRUG).
Who is sponsoring clinical trial NCT02674399?
This trial is sponsored by Nature Cell Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
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