Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis

Study Overview
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Brief Summary
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This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.

Detailed Description
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This is a prospective, randomized, placebo controlled, parallel groups, double blind, multi-center, interventional study of subjects with osteoarthritis of the knee. Subjects will be randomized to receive an injection of LR (placebo) or SVF derived from their own adipose tissue (experimental).

Official Title
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Use of GID SVF-2 Device to Produce Autologous Adipose-Derived Stromal Vascular Fraction for Treatment of Osteoarthritis of the Knee: A Pivotal Medical Device Randomized Concurrent Controlled Study

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: GID SVF-2 Device System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral or unilateral knee osteoarthritis as diagnosed on pre-op MRI using the Outerbridge Cartilage Classification as Grade II, Grade III, or Grade IV with full thickness lesion of the articular cartilage is less than 2.5 cm in any direction Kellgren and Lawrence score grade 2-4 as diagnosed on X-Ray Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20 total points) 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 Males and females 35-85 years old Subjects with BMI ≥22 and ≤ 37 Subjects must speak, read and understand English Subjects must be able to return for multiple follow-up visits Subjects must have failed at least two conservative therapies for treatment of knee OA within the last 24 months (2 years), with one or more of the failed conservative therapies being from a-f: Physical Therapy: 6 week course of treatment Exercise Therapy: 6 week course of treatment Viscosupplementation injection in the knee for OA pain Steroid injection in the knee for OA pain Platelet-Rich Plasma (PRP) injection in the knee for OA pain Arthroscopic surgery including microfracture and/or debridement Braces or other support devices: therapy tried for at least 2 weeks Over the Counter (OTC) pain medication including NSAIDS, Acetaminophen, ASA: therapy tried for at least 2 weeks Prescription pain medication: therapy tried for at least 1 weeks Modification of Activities of Daily Living (ADL): therapy tried for at least 2 weeks Topical applications to the knee for OA pain: therapy tried for at least 2 weeks Supplements including glucosamine sulfate and chondroitin sulfate: therapy tried for at least 4 weeks Ice/Heat regimen: therapy tried for at least 2 weeks Exclusion Criteria: Subjects whose knee pain is caused by: i. unstable meniscal root tears or locked bucket handle meniscal tears ii. displaced meniscus tear iii. osteo chondritis dissecans iv. parameniscal, Baker's, or ganglion cysts v. lipoma arborescens vi. Hoffa's Pad Syndrome vii. acute ligament tears viii. diffuse edema ix. patellar mal-tracking or patellar dislocations Outerbridge Scale Grade 0-I as diagnosed on MRI Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 2.5 cm in any direction, as diagnosed on MRI Subjects with malignant neoplasms of the bone, cartilage, synovium or vasculature. Subjects who have had surgery of either knee within 6 months prior to the surgery visit Subjects who have had a major injury to either knee within 12 months prior to the surgery visit Subjects who have had an injection into the intraarticular space of either knee in the prior 6 months, including corticosteroids, viscosupplementation, stromal vascular fraction (SVF), bone marrow stem cells, or platelet rich plasma Subjects who have a diagnosis of gout with a flare in the past 12 months. Subjects who have a diagnosis of Pes Anserine Bursitis with an event in the past 12 months. Subjects who have had a diagnosed infection in the knee joint in the past 12 months. Subject who have received a diagnosis of the following at any time: rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, fibromyalgia, or neurogenic or vascular claudication Diagnosis of severe bone deformity defined as greater than 10 degrees of either varus or valgus deformity Subjects that are unwilling to stop taking prescription or over the counter pain medication 7 days prior to any visit (except Day 2 Post Treatment Visit). 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 (colpidogrel) for 3 days, ASA/NSAIDs/fish oil supplements for 7 days, Xarelto® (rivaroxaban) for 24 hours Subjects with systemic immunosuppressant use within 6 weeks from screening Subjects with HIV or viral hepatitis Subjects who have ever received a diagnosis of: chondrocalcinosis, Paget's disease or Villonodular synovitis Subjects that use any form of tobacco, including e-cigarettes, more than once a week over the most recent 1 year period Women that are pregnant or planning to become pregnant during the study Subjects on long term oral steroids defined as longer than a 2-week taper. History of any chemotherapy or radiation therapy on either leg or adipose harvest site Subjects currently on workers' compensation

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive an injection of Lactated Ringers in their index knee | Device: GID SVF-2 Device System<br>* The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.<br>|
| Experimental: Stromal Vascular Fraction (SVF)<br>Subjects will receive an injection of Stromal Vascular Fraction in their index knee | Device: GID SVF-2 Device System<br>* The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Arthritis Index | The WOMAC is a self-administered questionnaire consisting of 14 items divided into 3 subscales, pain, stiffness and function. The primary efficacy will be achieved if the SVF dose group is shown to have a clinically meaningful improvement in pain and function at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The overall WOMAC score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Summary of device, treatment and procedure related adverse event rates and severity | 12 months |