Can your own fat cells rebuild a damaged knee?
NCT ID NCT05526898
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial is testing whether injecting a person's own fat tissue, processed with a special device, can reduce pain and improve function in people with knee osteoarthritis. Participants will receive either the fat tissue injection or a standard corticosteroid injection. The study will compare changes in knee pain and function over time to see if this approach offers a better treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Autologous microsized adipose tissue processed with the SyntrFuge system, compared to a corticosteroid injection (standard care)
- What this could lead to
- If effective, this could offer a new, minimally invasive treatment option for knee osteoarthritis that may reduce pain and improve joint function without surgery.
- What could go wrong
- This is an early-stage trial, and the treatment may not prove more effective than standard care. Risks include injection-related discomfort, infection, or variable results depending on individual response.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 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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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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 * 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 Criteria: * 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
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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
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 places running it
2 sites. The list below names each one and where it is.
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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
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Irvine Site 1
Irvine, California, 92618, United States
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Irvine Site 2
Irvine, California, 92618, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smartphone replace a physio visit for older adults with knee arthritis?
- One shot for knee pain? trial tests a new injection for osteoarthritis