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.

NCT ID: NCT07106229

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2030-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

20M MAG200

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

Group Type: EXPERIMENTAL

allogeneic human adipose-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

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

100M MAG 200

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

Group Type: EXPERIMENTAL

allogeneic human adipose-derived mesenchymal stem cells

Intervention Type: BIOLOGICAL

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

Interventions

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).

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females aged ≥ 35 years to ≤ 75 years inclusive.

2. BMI ≥ 19.0 to ≤ 35.0 kg/m2.

3. Documented clinical diagnosis of OA of the study knee.

4. Documented radiological grading of Grade 2 or Grade 3 medial and/or lateral compartment OA of the study knee.

5. Documented radiological grading of OARSI JSN 1-2 of the medial and/or lateral compartment of the study knee.

6. Primary OA treatment of the study knee already attempted within the last 12 months, defined as:

1. Prescribed analgesia/anti-inflammatory medication where appropriate, AND

2. an attempted exercise program prescribed by a physical therapist (e.g., physiotherapist, osteopath) or medical practitioner for at least 8 weeks, AND

3. weight management, where appropriate.

7. Moderate to severe knee specific activity related pain score on the NRS for Pain over the past week.

8. Moderate to severe knee specific functional limitation on KOOS-PS.

9. Less than 5 degrees varus or valgus knee deformity of the study knee relative to neutral alignment.

Exclusion Criteria

1. Any of the following relating to the study knee:

1. Radiological evidence of KL Grade 4 OA (involving medial, lateral and/or patellofemoral compartment) or OARSI JSN 3.

2. History of recurrent mechanical instability and / or locking.

3. Joint surgery or significant knee injury within 12 months prior to Day 1.

4. Metal in-situ resulting in metal artefact which impacts/prevents MRI assessment.

5. 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)

2. Other causes of the knee symptoms unrelated to knee OA.

3. Significant and debilitating OA in the non-study knee.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Magellan Stem Cells

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Julien Freitag, MBBS, BMedSci

Role: CONTACT

clinicaltrials@magellanstemcells.com.au

+61385189228

Other Identifiers

MSC-OAK-003

Identifier Type: -

Identifier Source: org_study_id