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 | Not Yet Recruiting Phase 3

• 1 other identifier: MSC-OAK-003
• Study Type: interventional
• Target: 573
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthristis

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (3)

• To assess the effect of MAG200 on osteoarthritis pain

  1, 3, 6, 9, and 12 months

• To assess the response rate of MAG200

  1, 3, 6, 9, and 12 months

• To assess the effect of MAG200 on radiological progression

  12 months

Other Outcomes (1)

• Adverse event reporting

  Baseline to 12 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

20M MAG200

EXPERIMENTAL

Participants in this arm will receive MAG200 at a dose of 20 million cells (20M).

Biological: allogeneic human adipose-derived mesenchymal stem cells

100M MAG 200

EXPERIMENTAL

Participants in this arm will receive MAG200 at a dose of 100 million cells (100M)

Biological: allogeneic human adipose-derived mesenchymal stem cells

Interventions

allogeneic human adipose-derived mesenchymal stem cells BIOLOGICAL

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

100M MAG 200; 20M MAG200

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• weight management, where appropriate.
• Moderate to severe knee specific activity related pain score on the NRS for Pain over the past week.
• Moderate to severe knee specific functional limitation on KOOS-PS.
• Less than 5 degrees varus or valgus knee deformity of the study knee relative to neutral alignment.

You may not qualify if:

• Any of the following relating to the study knee:
• Radiological evidence of KL Grade 4 OA (involving medial, lateral and/or patellofemoral compartment) or OARSI JSN 3.
• History of recurrent mechanical instability and / or locking.
• Joint surgery or significant knee injury within 12 months prior to Day 1.
• Metal in-situ resulting in metal artefact which impacts/prevents MRI assessment.
• MRI confirmed:
• i. Generalised full thickness chondral loss involving tibial and/or femoral weight bearing surfaces ii. Total meniscectomy iii. Complete posterior meniscal root tear iv. Subchondral insufficiency fracture v. Osteonecrosis vi. Malignant bone marrow infiltration vii. Solid tumors viii. Traumatic fracture/bone contusion ix. Knee pathology requiring orthopaedic assessment/intervention (e.g., significant loose body)
• Other causes of the knee symptoms unrelated to knee OA.
• Significant and debilitating OA in the non-study knee.

Sponsors & Collaborators

• Magellan Stem Cells: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Julien Freitag, MBBS, BMedSci

CONTACT

+61385189228; clinicaltrials@magellanstemcells.com.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in this study 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).

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 6, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Individual de-identified participant data which underlie results reported in this article will be available upon publication. Material will be accessible to investigators whose proposed use of data has been approved by an independent review committee and for data meta-analysis. Requests are to be directed to the corresponding author of the article. No end date is given for request of data.
• Access Criteria: Requests are to be directed to the corresponding author of the article (clinicaltrials@magellanstemcells.com.au)