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RECRUITING
NCT04368806
PHASE2/PHASE3

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

Sponsor: Nature Cell Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2021-05-26

Completion Date

2026-12-31

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DRUG

JointStem

Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)

OTHER

Placebo Control

Normal Saline with autologous Serum

Locations (9)

TriWest Research Associates

El Cajon, California, United States

BioSolutions Clinical Research Center

La Mesa, California, United States

Neurovations Research

Napa, California, United States

Newport Therapeutics

Newport Beach, California, United States

Source Healthcare

Santa Monica, California, United States

Keimyung University Dongsan Hospital

Daegu, Korea, South Korea

Kyung Hee University Medical Center

Seoul, Korea, South Korea

Kyung Hee University Hospital At Gangdong

Seoul, Korea, South Korea

Smg-Snu Boramae Medical Center

Seoul, Korea, South Korea