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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
573
The Investigational Product MAG200 is a preparation of 5 mL allogeneic human adipose-derived mesenchymal stem cells (MSCs).
Placebo is commercially available injectable normal saline (0.9% Sodium Chloride in Water for Injection)
To assess the effect of MAG200 on osteoarthritis pain and function
Co-primary endpoints: * Change from baseline in pain by Knee Injury and Osteoarthritis Outcome Score pain subscale (KOOS Pain): 0-100 scale (0=extreme knee pain, 100=no knee pain) * Change from baseline in function as measured by Knee Injury and Osteoarthritis Outcome Score function in daily living subscale (KOOS-ADL): 0 to 100 scale (0=extreme knee problems, 100=no knee problems)
Time frame: 12 months
To assess the effect of MAG200 on osteoarthritis pain
Change from baseline in activity related pain assessed using an 11-point (0 to 10) Numeric Rating Scale (NRS) (0=no pain, 10=extreme pain)
Time frame: 1, 3, 6, 9, and 12 months
To assess the response rate of MAG200
Response according to OMERACT-OARSI (Outcome Measures in Rheumatology - Osteoarthritis Research Society International) Responder Analysis. OMERACT-OARSI response is defined as either 1) improvement in pain or physical function ≥ 50% and an absolute change ≥ 20 points on a 0-100 scale; or 2) improvement of ≥ 20% and with an absolute change ≥ 10 points on a 0 to 100 scale in at least two of the following three categories: pain, physical function, and patient's global assessment of osteoarthritis activity.
Time frame: 1, 3, 6, 9, and 12 months
To assess the effect of MAG200 on radiological progression
Change from baseline in articular cartilage thickness assessed by quantitative MRI
Time frame: 12 months
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