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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.

NCT07106229 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 573

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Knee Osteoarthristis

Interventions

BIOLOGICAL

allogeneic human adipose-derived mesenchymal stem cells

The Investigational Product MAG200 is a preparation of 5 mL allogeneic human adipose-derived mesenchymal stem cells (MSCs).

OTHER

Placebo

Placebo is commercially available injectable normal saline (0.9% Sodium Chloride in Water for Injection)

Sponsors & Collaborators

  • Magellan Stem Cells

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2028-02-29
Completion
2030-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106229 on ClinicalTrials.gov