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Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee

Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee

NCT03940950•Mayo Clinic

View on ClinicalTrials.gov

Summary

Researchers are trying to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+22 more criteria

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Key Dates

Start Date

July 2, 2019

Primary Completion Date

May 5, 2025

Completion Date

May 23, 2025

Last Updated

January 27, 2026

Enrollment

ACTUAL participants

Conditions

Osteo Arthritis KneeDegenerative Joint Disease of Knee

Interventions

Autologous Adipose-Derived SVF (Stromal Vascular Fraction)

BIOLOGICAL

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee

Inclusion Criteria

Exclusion Criteria

Total Versus Robotic Assisted Unicompartmental Knee Replacement

Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage

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