Osteo Arthritis KneePhase 1NCT03940950
Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee
A Phase 1 study testing Autologous Adipose-Derived SVF (Stromal Vascular Fraction) in people with Osteo Arthritis Knee and Degenerative Joint Disease of Knee, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee, Degenerative Joint Disease of Knee
- What is being tested?
- Autologous Adipose-Derived SVF (Stromal Vascular Fraction)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2019to 23 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee
Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis
- Being tested
- Autologous Adipose-Derived SVF (Stromal Vascular Fraction), Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose-Derived SVF (Stromal Vascular Fraction)Biological
60 ml of fat is collected from subjects abdominal wall and SVF is removed from the fat. The SVF is injected into the knee through a needle.
PlaceboDrug
Saline control that contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| SVF (Stromal Vascular Fraction) Group | Experimental | Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells Receives: Biological: Autologous Adipose-Derived SVF (Stromal Vascular Fraction) |
| Placebo Group | Placebo comparator | Subjects with knee osteoarthritis (OA) will be treated with a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of adverse events reported
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start2 Jul 2019
- Primary completion5 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shane A. Shapiro, Mayo Clinic
- Investigators
- Shane A Shapiro, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940950
- Sponsor's protocol ID
- 18-006909
- Status last verified
- Jan 2026
- First submitted
- 6 May 2019
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03940950
- Acronym / sponsor ID
- 18-006909
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF (Stromal Vascular Fraction) Group | Experimental | Biological: Autologous Adipose-Derived SVF (Stromal Vascular Fraction)Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects with knee osteoarthritis (OA) will be treated with a placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Adipose-Derived SVF (Stromal Vascular Fraction)60 ml of fat is collected from subjects abdominal wall and SVF is removed from the fat. The SVF is injected into the knee through a needle. | Biological | SVF (Stromal Vascular Fraction) Group |
| PlaceboSaline control that contains no active ingredient | Drug | Placebo Group |
Primary outcome
Adverse Events
Time frame: 2 years
Number of adverse events reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane A Shapiro principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Adipose-Derived SVF (Stromal Vascular Fraction) in people with Osteo Arthritis Knee and Degenerative Joint Disease of Knee, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.