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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: Recruiting Phase 2 study of Osteoarthritis, Knee, sponsored by Nature Cell Co..

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 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (72% lower). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Change from baseline in WOMAC function score at Week 48

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

FieldValue
Enrollment Target 140 participants
Start Date 2021-05-26
Est. Completion 2026-12-31
Phase Phase 2
Nature Cell Co.

3 total trials

What NCT04368806 shows while recruiting

NCT04368806 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (72% lower).

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 lists 9 locations in 2 states (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.

Similar trials for Osteoarthritis, Knee

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04368806's enrollment target sits among peer trials

140 50th of 112 higher than 63 of 112 other Osteoarthritis, Knee trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04368806, the US trial registry maintained by the National Library of Medicine. NCT04368806 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.