Evaluating the SyntrFuge™ System for Knee Osteoarthritis

This study is looking at how well a treatment using your own fat tissue, processed with the SyntrFuge™ system, works for knee osteoarthritis. You might receive an injection of this processed fat tissue or standard care, which could be a Triamcinolone injection (a corticosteroid). Researchers want to see if this new approach helps reduce knee pain and improve function. To join, you need to be between 35 and 80 years old, have knee osteoarthritis (grades II, III, or IV), and have had knee pain for at least three months. The study aims to enroll 176 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a multi-center study, involving several locations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your knee pain and function will be checked at 6 months, 12 months, and 24 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05526898

Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Knee Osteoarthritis

Not Yet Recruiting
NAAges 18–70InterventionalTreatment
Syntr Health Technologies, Inc.
~180 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:SyntrFuge SystemTriamcinolone Injection

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
WOMAC
Measured over 6 months, 12 months, 24 months
Knee Osteoarthritis

NCT05526898

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Irvine Site 1

    Irvine, Californiano site contact published

  • Irvine Site 2

    Irvine, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

Subjects aged of 35-80 years old
Patients with knee osteoarthritis grade II, III, and IV Kellgren-Lawrence
Chronic knee pain or symptoms for at least 3 months
BMI between 20 and 34.9
Willing and able to read and sign the informed consent and other study materials
Written informed consent has been obtained prior to any study-related procedures
Written Authorization for Use and Release of Health and Research Study Information has been signed
Subjects are ambulatory
Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
Females of childbearing potential must have a negative urine pregnancy test result and not be lactating
Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation

Exclusion

Subjects with previous traumatic lesion (tibial fracture, osteothomy) of the knee
Subjects with osteonecrosis
Subjects with meniscal surgery in the previous 6 weeks
Subjects with gout, hyperlipidemia
Subjects without decisional capacity
Subjects with inflammatory arthritis
Subjects with active infection
Subjects with any uncontrolled systemic disease
Subjects with a history of severe allergic/anaphylactic reactions or multiple allergies
Subjects planning to become pregnant, are pregnant, or are breast-feeding
Subjects with history or current evidence of drug or alcohol abuse within 36 months prior to screening visit
Subjects who have active autoimmune disease
Subjects who have coagulation disorders
Subjects who have received any other therapy, which, in the opinion of the investigator, could interfere with safety or efficacy evaluations
Subjects with current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
Subjects who have received anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti- inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen), or other substances known to increase coagulation time from 7 days pre- to 3 days post injection. A wash out period of 7 days is allowed
Subjects who have undergone immunosuppressive therapy, chemotherapy, biologics or systemic corticosteroids within 3 months prior to each study visit.
No intra-articular injection of corticosteroids within the last 24 weeks
No intra-articular injection of any other cellular therapy within the last 24 weeks
  • WOMAC6 months, 12 months, 24 months

    Change of WOMAC Score from Baseline