Fat cell knee injection trial for Post-Trauma arthritis pulled before start
NCT ID NCT05515523
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot trial aimed to test the safety and feasibility of a single injection of a patient's own fat-derived cells (stromal vascular fraction) into the knee for post-traumatic osteoarthritis. It was designed for adults aged 18–45 with a history of knee injury. However, the study was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stromal vascular fraction (SVF) cells from the patient's own fat tissue
- What this could lead to
- If successful, this approach could point toward a way to reduce pain and improve knee function after injury-related arthritis, possibly delaying or avoiding joint replacement.
- What could go wrong
- This was a very early pilot trial (Phase 1) that was withdrawn before any participants were enrolled, so no safety or effectiveness data exist. The approach is still highly experimental and unproven.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 45 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Males and females 18 - 45 with a preceding history (\>1 and \< 20 years ago) of significant knee trauma or trauma- related knee surgery * Post-Trauma Osteoarthritis (PTOA) as diagnosed by K-L Grade II or III OA (weight bearing X-ray) and physician review * Subjects must present with symptomatic (injured knee) visual analog scale (VAS) pain \> 4. If bilateral disease, Knee Osteoarthritis (KOA) pain in the other knee must be less than/equal to 3 on the VAS for pain * Subjects must have an adjusted Western Ontario and McMaster Universities Arthritis Index (WOMAC) (100-point scale) of \> 25 and \<90 * Study Subjects must have continued knee pain despite at least two conservative prescribed therapies (pain medications, physical therapy, knee injections, or weight loss), spanning a period of at least 3 months * Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed * Subjects will be in good health (ASA Class I-II) with a Body mass index (BMI) \< 35 * Subjects must speak, read, and understand English * Subjects must be reasonably able to return for multiple follow-up visits, to include procedure visits Exclusion Criteria: * Subjects whose knee pain is caused by, (i) diffuse edema, (ii) cartilage lesion greater than 1 cm width and grade 4 depth by MRI or (iii) osteochondritis dissecans * Subjects who have had surgery of either knee within 12 months prior to the screening visit * Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation, stem cells, or platelet rich plasma (PRP) * Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, or neurogenic or vascular claudication * Subjects who have symptomatic Osteoarthritis (OA) of the hips, spine, or ankle that would interfere with the evaluation of the treated knee * Subjects that are unwilling to stop taking prescription or over the counter pain and anti-inflammatory medication for 7 days prior to any visit * Subjects that are allergic to lidocaine, epinephrine, or valium or other sedatives * Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped prior to IA injection * Subjects with systemic immunosuppressant use within six (6) weeks from screening * Subjects with human immunodeficiency virus (HIV)/viral hepatitis B or human T-lymphotropic virus type 1 (C/HTLV) * Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis * Subjects that use any form of tobacco * Women that are pregnant or planning to become pregnant during the study * Subjects on long term use of oral steroids or disease-modifying anti-rheumatic drugs * History of any chemotherapy or radiation therapy of the targeted/treatment leg or adipose harvest site * Subjects currently on worker's compensation
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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.
Contacts and locations
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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