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NCT04368806 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
A Phase 2 study of Osteoarthritis, Knee, sponsored by Nature Cell Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 9
- Study locations
NCT04368806 is a Phase 2 study of Osteoarthritis, Knee that is actively recruiting participants, run by Nature Cell Co.. The registered enrollment target is 140 participants, below the 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (76% lower). The trial reports 9 study locations across 2 states.
The verdict
NCT04368806, a Phase 2 study of Osteoarthritis, Knee, is actively recruiting participants, sponsored by Nature Cell Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo Control
- DRUG JointStem
Study Locations (9)
California
- TriWest Research Associates - El Cajon
- BioSolutions Clinical Research Center - La Mesa
- Neurovations Research - Napa
- Newport Therapeutics - Newport Beach
- Source Healthcare - Santa Monica
Korea
- Keimyung University Dongsan Hospital - Daegu
- Kyung Hee University Medical Center - Seoul
- Kyung Hee University Hospital At Gangdong - Seoul
- Smg-Snu Boramae Medical Center - Seoul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-05-26 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04368806
The ClinicalTrials.gov registry entry for NCT04368806 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (76% lower). The listed sponsor is Nature Cell Co., which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo Control is the first listed.
NCT04368806 reports 9 study locations spanning 2 distinct geographic areas - top geographies include California, Korea.
Frequently Asked Questions
What is clinical trial NCT04368806 about?
NCT04368806 is a clinical study titled "A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis". 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, approxi...
What is the current status of trial NCT04368806?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2021-05-26. Estimated completion is 2026-12-31.
What conditions does trial NCT04368806 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee.
What interventions are being tested in trial NCT04368806?
The interventions under investigation include: Placebo Control (OTHER), JointStem (DRUG).
Who is sponsoring clinical trial NCT04368806?
This trial is sponsored by Nature Cell Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04368806 being conducted?
This trial has 9 study locations across California, Korea. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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