Could a single stem cell shot ease arthritic knees?
NCT ID NCT07106229
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 3 trial tests whether a single injection of MAG200 stem cells can improve pain and daily function in adults with knee osteoarthritis. About 573 participants will receive either a low dose, a high dose, or a placebo injection. The study aims to confirm if this approach offers a meaningful benefit over placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MAG200 (allogeneic adipose-derived mesenchymal stem cells)
- What this could lead to
- If it works, this could provide a new, single-injection treatment to reduce pain and improve daily function for people with knee osteoarthritis.
- What could go wrong
- This is a large Phase 3 trial, but stem cell treatments for osteoarthritis have had mixed results in earlier studies. The effect may be modest, and long-term safety is still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 573 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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