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Could your own belly fat fix your aching knee? early trial says maybe

NCT ID NCT03940950

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tested whether injecting a special mixture of cells from a person's own belly fat into their arthritic knee is safe and doable. Nine adults with knee osteoarthritis received the injection. The main goal was to check for side effects, not to measure pain relief, so we don't yet know if it works.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

9 people

The number who actually took part.

Started

Jul 2019

Finished

May 2025

Lead sponsor

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

40 to 75 years

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Male or female ages 40-75 years * Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit. * Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs associated with pregnancy will be recorded. Radiographic assessment will be deferred if the patient becomes pregnant. * Radiographic medial and/or lateral femorotibial knee OA Kellgren-Lawrence grade 2 or 3 accompanied by definite joint space narrowing as agreed upon by two study coinvestigators. If no agreement, a musculoskeletal radiologist not associated with the study will make the final grading. * Previous 3 month or longer trial of one of the following conservative treatments: activity modification, weight loss, physical therapy, anti-inflammatory medications or injection therapy (e.g. cortisone, hyaluronic acid/viscosupplement). * Able to routinely walk without assistance (e.g. cane, walker). * Clinically stable target knee. * Completed general physical evaluation with primary care provider within 12 months of enrollment. * Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including fat harvesting, laboratory tests, diagnostic imaging, repeated knee injections/aspirations, arthroscopic examination and follow-up visits and assessments. * Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure. * Subjects taking medications for symptomatic relief of OA under the supervision of their primary caregiver, including non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) may continue to take these medications unless they are otherwise excluded by the protocol and as long as the dosing has been stable for 4 weeks before baseline and is anticipated to remain stable until at least 30 days following completion of the subject's treatment cycle. Exclusion Criteria * Pregnant or nursing, or planning on becoming pregnant during the study period. * Congenital or acquired malformation of the target knee resulting in significant deformity or leading to problems with the study treatment or analysis of the results. * Significant clinical malalignment requiring follow-up full length, standing X-rays. * Orthopedic hardware or implantable devices anywhere in the body, other than dental. * Surgery on the index knee within 1 year of study enrollment. * Injections of any into the index knee within 3 months prior to study enrollment. * Locking, catching, give-away or another major mechanical symptom of the target knee. * Kellgren-Lawrence Grade 1 or-4 arthritis in the index knee. * History of intra-articular infection in the index knee. * History of superficial infection in the index knee within 6 months of study enrollment, or evidence of current superficial infection affecting the index knee. * History of falls requiring medical attention, or gait instability. * Abnormal hematology (complete blood count with differential), blood chemistry (Glucose, Calcium, Sodium, Potassium, Bicarbonate, Chloride, BUN, Creatinine, Anion Gap), or urinalysis screening laboratory results, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), , and CRP.. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the patient wishes. Normalization of that laboratory study will then be considered nonexclusionary. See Section 14.3, Appendix 3. * Body mass index (BMI) \> 40 kg/m2. * Taking anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix). * Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to avoid use of herbal therapies or supplements until at least 30 days following completion of the study drug treatment cycle (includes, but not limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin). * Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating not remaining on a stable dose until at least 30 days following completion of the study drug treatment cycle. * Use of electrotherapy or acupuncture for OA, unless there is a stable regimen for at least 4 weeks before baseline assessment. * Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment. * On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids. * Current tobacco product use, including nicotine patch or other nicotine products. * Systemic inflammatory, rheumatological or connective tissue disorder including but not limited to rheumatoid arthritis, systemic sclerosis, system lupus erythematosus, and Ehlers-Danlos Syndrome. * Rheumatological or inflammatory disease of the knee or chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis. * Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis. * Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension \> 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g. stroke, TIA) renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will interfere with study, osteoporosis, acute lower body fractures), or endocrine disease (e.g. diabetes). * Vascular or neurological disorder affecting the index either lower limb. * History of cancer/malignancy with the exception of adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee within the last 5 years. * History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy. * Participation in a study of an experimental drug or medical device within 3 months of study enrollment. * Known allergy to local anesthetics of other components of the study drug. * Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures. * History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry. * Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

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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

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.