Use of Autologous Adipose-Derived Stromal Vascular Fraction To Treat Osteoarthritis of Hip, Knee, Ankle, and Thumb Joints

Status unconfirmed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT03166410

Run by

Texas Plastic Surgery

People needed

500

Starts

2017-01-01

Expected to finish

2021-07-01

Last updated by the study team

2020-03-13

Who can join

Age: 25 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Texas Plastic Surgery — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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