WithdrawnNot Applicable

Use of MRI Labeling Technique to Track Mesenchymal Stem Cell Survival in Orthopaedic Conditions

Stopped: Investigator left institution

0Started 2019-10-01

Plain-language summary

The primary objective is to determine whether a surgical intervention involving removing of the calcified cartilage cap in patients with Grade II Kellgren-Lawrence osteoarthritis influences the incorporation of labeled bone marrow aspirate concentrate (BMAC)-derived cells within the cartilage regenerate vs labeled BMAC cells delivered after arthroscopy without removing of the calcified cartilaginous layer. The survival and incorporation of the BMAC labeled cells will be evaluated with MRI using the Ferumoxytol infusion stem cell labeling technique. The second arm of the study evaluating cell fate after injecting stem cells under a rotator cuff repair will also be explored. The secondary objectives are to 1) determine which surgical intervention leads to better clinical outcomes as measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) at 12 months, and 2) determine who long we can track the labeled-BMAC cells in the knee.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

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Inclusion criteria

. Adults aged 30-70 patients with Kellgren grade II-III osteoarthritis,
. Symptomatic knee pain greater than 6 months
. At least one discrete contained chondral defect
. Failed a minimum of 6 weeks of physical therapy
. Grossly normal knee alignment: \<5 degrees of varus or valgus alignment
. Lesion located on medial or lateral femoral condyle or trochlea

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Integration of the mesenchymal stem cells.

Timeframe: 3 months

Trial details

NCT IDNCT03648463

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Cartilage Degeneration trials