Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints
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This study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells for treatment of hip, knee and thumb osteoarthritis (OA); monitoring adverse events and measuring pain, function and stiffness in the joints of osteoarthritic subjects.
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Ages Eligible for Study:
25 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Grade II through Grade IV hip, knee, ankle osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI
Stage II through IV carpometacarpal (CMC) osteoarthritis using Eaton-Little's staging of CMC OA as diagnosed by X-ray and physical examination
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 with ASA grade I, II, or III
Males and females 25-85 years old
Subjects must have continued pain in their targeted/treatment joint despite conservative therapies for at least 3 months
Subjects that are allergic to lidocaine, epinephrine or valium
Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as follows prior to injection; Thrombolytics and anti-platelet medication including but not limited to Coumadin (warfarin) for 3 days, Plavix (clopidogrel) for 3 days, acetylsalicylic acid (ASA)/NSAIDs/fish oil supplements for 7 days, Xeralta® (rivaroxaban) for 24 hours
Subjects with systemic immunosuppressant use within six (6) weeks from screening and subjects with HIV/viral hepatitis
Subjects with chondrocalcinosis, Paget's disease and Villonodular synovitis
Women that are pregnant or planning to become pregnant during the study
Subjects on long term use of oral steroids
History of any chemotherapy or radiation therapy on the targeted/treatment joint or adipose harvest site