Knee OsteoarthristisPhase 3nexcell-OAKNCT07106229
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.
A Phase 3 study testing allogeneic human adipose-derived mesenchymal stem cells in people with Knee Osteoarthristis, run by Magellan Stem Cells.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- allogeneic human adipose-derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 573 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Multicentre, Randomised, Double Blind, Placebo-controlled Study to Evaluate the Effectiveness, Safety, and Tolerability of MAG200 (an Allogeneic Adipose-derived Mesenchymal Stem Cell Preparation) Administered by Intra-articular Injection to Adult Participants With Symptomatic Osteoarthritis of the Knee.
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
- Being tested
- allogeneic human adipose-derived mesenchymal stem cells, Placebo
- Keywords
- osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic human adipose-derived mesenchymal stem cellsBiological
The Investigational Product MAG200 is a preparation of 5 mL allogeneic human adipose-derived mesenchymal stem cells (MSCs).
PlaceboOther
Placebo is commercially available injectable normal saline (0.9% Sodium Chloride in Water for Injection)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| 20M MAG200 | Experimental | Participants in this arm will receive MAG200 at a dose of 20 million cells (20M). Receives: 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) Receives: Biological: allogeneic human adipose-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startNov 2025 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 573 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magellan Stem Cells
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106229
- Sponsor's protocol ID
- MSC-OAK-003
- Acronym
- nexcell-OAK
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome data of published/reported results
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicentre, Randomised, Double Blind, Placebo-controlled Study to Evaluate the Effectiveness, Safety, and Tolerability of MAG200 (an Allogeneic Adipose-derived Mesenchymal Stem Cell Preparation) Administered by Intra-articular Injection to Adult Participants With Symptomatic Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT07106229
- Acronym / sponsor ID
- nexcell-OAK / MSC-OAK-003
- Conditions
- Knee Osteoarthristis
- Keywords
- osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 573 participants (estimated)
- Lead sponsor
- Magellan Stem CellsIndustry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| 20M MAG200 | Experimental | Biological: allogeneic human adipose-derived mesenchymal stem cellsParticipants in this arm will receive MAG200 at a dose of 20 million cells (20M). |
| 100M MAG 200 | Experimental | Biological: allogeneic human adipose-derived mesenchymal stem cellsParticipants in this arm will receive MAG200 at a dose of 100 million cells (100M) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- Any of the following relating to the study knee:
- Other causes of the knee symptoms unrelated to knee OA.
- Significant and debilitating OA in the non-study knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic human adipose-derived mesenchymal stem cellsThe Investigational Product MAG200 is a preparation of 5 mL allogeneic human adipose-derived mesenchymal stem cells (MSCs). | Biological | 100M MAG 200, 20M MAG200 |
| PlaceboPlacebo is commercially available injectable normal saline (0.9% Sodium Chloride in Water for Injection) | Other | Placebo |
Primary outcome
To assess the effect of MAG200 on osteoarthritis pain and function
Time frame: 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)
3 secondary outcomes
To assess the effect of MAG200 on osteoarthritis pain
Time frame: 1, 3, 6, 9, and 12 months
To assess the response rate of MAG200
Time frame: 1, 3, 6, 9, and 12 months
To assess the effect of MAG200 on radiological progression
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes. Outcome data of published/reported results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing allogeneic human adipose-derived mesenchymal stem cells in people with Knee Osteoarthristis, run by Magellan Stem Cells.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Freitag, MBBS, BMedSci (+61385189228, clinicaltrials@magellanstemcells.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of MAG200 on osteoarthritis pain and function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.