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

Study 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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Cell injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell Treatment<br> | Procedure: Cell injection<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Incidence of Treatment-Emergent Adverse Events | Subjects will be monitored for adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Change in Pain Scores at All Follow-up Visits | Pain scores will be collected at all visits | 3 months, 6 months, 1 year, 2 years |