Fat cells to the rescue? new treatment for arthritic knees enters human testing
NCT ID NCT06485843
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new treatment called OA-SYS, made from cells taken from fat tissue, for people with moderate to severe knee osteoarthritis. The main goal is to see if it is safe and tolerable. 400 adults aged 35-75 with knee arthritis will receive the treatment and be monitored for side effects and changes in pain and function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OA-SYS (cells from fat tissue)
- What this could lead to
- If safe and effective, OA-SYS could offer a new way to manage knee osteoarthritis pain and reduce reliance on painkillers.
- What could go wrong
- This is an early Phase IIb trial focused on safety, not yet proven to work. The treatment involves cells from fat, and long-term benefits or risks are unknown.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Dec 2028
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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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 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: * Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2 * Ambulatory and in good general health * Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions * Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment * Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee * No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments * For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method till end of the study period and negative pregnancy test * For males of reproductive potential: use of condoms and other methods to ensure effective contraception Exclusion Criteria: * Known or suspected infection of the target joint * Subjects with surgery for OA in the target joint * Subject with reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease * Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90 mmHg even with treatment with more than three antihypertensive drugs * Subject with serious medical conditions other than cardiovascular disease * Subject with, or with a medical history of autoimmune diseases * Subject with an infection that requires parenteral antibiotic administration within 30 days prior to screening * Subject with a medical history of mental disorder or epilepsy * Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day * Subject who was diagnosed with cancer within 5 years before screening * Subject who participated in another clinical trial within 6 months prior to the screening of this clinical trial * Subject who was administered with immunosuppressants such as cyclosporin A or azathioprine within 6 weeks prior to the screening * Subject who had intra-articular administration such as sodium hyaluronate injections within 6 months prior to the screening * Clinical findings consistent with active infection or crystal disease in the index joint within 1 month prior to the screening * History of fracture in the index limb or fracture with sequelae within 12 months prior to the screening * Joint instability or history of acute dislocation within 12 months prior to the screening * Planned or anticipated surgery of the joint during the study period * Presence of surgical hardware or other foreign body in the index joint * Surgery or arthroscopy of the index joint within 12 months of screening * Intra-articular treatment of any joint with any of the following agents within 6 months prior to the screening: Any corticosteroid preparation (investigational or marketed), any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection) * Treatment of the index joint with any investigational therapy within 6 months prior to the screening * Serious life-threatening conditions * Allergies to anesthesia * Subject who is breastfeeding.
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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 places running it
1 site. 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
Locations
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Orthopedic & Sports Medicine Institute of Las Vegas
RECRUITINGLas Vegas, Nevada, 89117, United States
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