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Could a single stem cell shot ease arthritic knees?

NCT ID NCT07106229

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 573 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

35 to 75 years

Sex

Anyone

Healthy volunteers

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

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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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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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