TerminatedPhase 4

Lipogems Prospective Study

Stopped: Recruitment was suspended due to the COVID pandemic and it was decided not to resume the study.

United States2 participantsStarted 2019-11-11

Plain-language summary

The purpose of this study is to study the clinical outcomes and effects of the injection of fat-derived stem cells (the scientific name being "adipose derived autologous stem cell transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling and pain associated with mild to moderate knee osteoarthritis. Management of this condition remains a pervasive problem within orthopaedics. Lipogems is a Food and Drug Administration (FDA) approved technique. Lipogems is the name of the technology used to obtain stem cells from fat that will be aspirated/removed by suction from the abdomen. Fat will be processed to obtain stem cells which will then be injected into the knee after the physician completes knee arthroscopy. The study that we are asking patients to enroll in is important because it will attempt to answer the question about whether fat-derived stem cells added to knee arthroscopy is better, worse or no different than knee arthroscopy alone. Currently, without this study, we do not have an answer to this question.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 70 years * Knee pain and symptoms for \>2 months - clicking, popping, giving way, pain with pivot or torque, pain that is episodic, and pain that is acute and localized to one joint * Conservative treatment \>4 weeks with one or more of: * Non-steroidal Anti-inflammatory Drugs (NSAIDS) or acetaminophen or contraindication to use of NSAIDs and acetaminophen, Activity limitations, Physical Therapy (PT) * Hospital for Special Surgery (HSS) MRI demonstrating grade 1-3 knee joint effusion/synovitis based on MRI Osteoarthritis Knee Score (MOAKS) criteria * K-L grade 0-3 on radiographs and/or cartilage thinning on MRI w/ or w/o meniscal tear * Ability to provide informed consent Exclusion Criteria: The patients listed below are excluded due to potential confound factors which may alter clinical outcomes in either treatment group (1,3,4,5 7,8, 11, 12,13), if they may potentially cause a ceiling or floor effect to our clinical outcomes (2,6,) or if the treatment may constitute and undue risk to the patient or be outside of the standard of practice of treatment for that patient (1, 9, 10,14, 15, 16) * 1\. Under 18 years of age or skeletally immature * 2\. Grade 4 radiographic Osteoarthritis (OA) as defined by the K-L classification * 3\. Grade 4 chondral lesion of patellofemoral joint on diagnostic arthroscopy * 4\. Major coronal plane malalignment (\>5° valgus or varus deviation) * 5\. Knee ligamentous instability * 6\. Pretreatment Numeric …

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?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

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

Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale

Timeframe: Baseline, 2-Week post-op, 6-Week post-op

Trial details

NCT IDNCT03922490

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-27

Results submitted2022-09-01

View on ClinicalTrials.gov More Knee Osteoarthritis trials