A Study to Investigate the Effectiveness, Safety, and Tolerability of MAG200 Solution for Intra-a… (NCT07106229) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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.
573 participantsStarted 2025-11
Plain-language 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.
Who can participate
Age range35 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and females aged ≥ 35 years to ≤ 75 years inclusive.
✓. BMI ≥ 19.0 to ≤ 35.0 kg/m2.
✓. Documented clinical diagnosis of OA of the study knee.
✓. Documented radiological grading of Grade 2 or Grade 3 medial and/or lateral compartment OA of the study knee.
✓. Documented radiological grading of OARSI JSN 1-2 of the medial and/or lateral compartment of the study knee.
✓. Primary OA treatment of the study knee already attempted within the last 12 months, defined as:
✓. Prescribed analgesia/anti-inflammatory medication where appropriate, AND
✓. an attempted exercise program prescribed by a physical therapist (e.g., physiotherapist, osteopath) or medical practitioner for at least 8 weeks, AND
Exclusion criteria
✕. Any of the following relating to the study knee:
What they're measuring
1
To assess the effect of MAG200 on osteoarthritis pain and function