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.

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthristis
• Interventions: Other: Placebo; Biological: allogeneic human adipose-derived mesenchymal stem cells

• Registration Number: NCT07106229
• Lead Sponsor: Magellan Stem Cells

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-11-01
• Primary Completion: 2028-02
• Study Completion: 2030-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 573

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
20M MAG200	allogeneic human adipose-derived mesenchymal stem cells	Participants in this arm will receive MAG200 at a dose of 20 million cells (20M).
100M MAG 200	allogeneic human adipose-derived mesenchymal stem cells	Participants in this arm will receive MAG200 at a dose of 100 million cells (100M)

Primary Outcome Measures

Name	Time	Method
To assess the effect of MAG200 on osteoarthritis pain and function	12 months	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)

Secondary Outcome Measures

Name	Time	Method
To assess the effect of MAG200 on osteoarthritis pain	1, 3, 6, 9, and 12 months	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)
To assess the response rate of MAG200	1, 3, 6, 9, and 12 months	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.
To assess the effect of MAG200 on radiological progression	12 months	Change from baseline in articular cartilage thickness assessed by quantitative MRI