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

Texas Plastic Surgery1 site in 1 country500 target enrollmentJanuary 2017

ConditionsOsteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Texas Plastic Surgery
Enrollment: 500
Locations: 1
Primary Endpoint: Safety - Incidence of Treatment-Emergent Adverse Events
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

July 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Texas Plastic Surgery

Responsible Party

Principal Investigator

Jaime R. Garza, MD

Principal Investigator

Texas Plastic Surgery

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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