Clinical Trial

A Study to Investigate the Effectiveness, Safety, and Tolerability of MAG200 Solution for Intra-articular Injection Compared With Placebo in Participants Aged 35 to 75 Years of Age With Symptomatic Osteoarthritis of the Knee.

Study acronym: nexcell-OAK
Not Yet Recruiting Phase 3
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Summary
The purpose of this study is to confirm whether MAG200 (20M or 100M) will improve pain and function of participants with osteoarthritis of the knee compared with placebo. In addition, the two strengths of MAG200 will be compared. In this study, participants will receive a single injection of placebo or allogeneic ADMSCs (MAG200) administered by IA injection. Participants will be randomised to receive placebo, or MAG200 at a dose of 20 million cells (20M), or MAG200 at a dose of 100 million cells (100M). It is anticipated that the study will run for approximately 48 months.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-29.
Trial Details
NCT Number NCT07106229
Lead Sponsor Magellan Stem Cells
Conditions Knee Osteoarthristis
Enrollment 573 participants
Start Date 2025-11
Primary Completion 2028-02 (estimated)
Study Completion 2030-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-12