Adipose-derived SVF for the Treatment of Knee OA

Study Overview
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Brief Summary
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This is a pivotal study. The study will examine the safety and efficacy of autologous adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for pain, function and stiffness in the knees of osteoarthritic subjects.

Detailed Description
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Osteoarthritis is the main form of arthritis and affects over 20 million people in the United States. In the knee it can cause severe pain, reduced functionality and increased stiffness thus, a treatment that would reduce pain, increase function and reduce stiffness would be of benefit to many people. This study will collect and disassociate adipose tissue and inject the stromal vascular fraction into the knee of the same patient. The study is controlled, randomized and double-blinded with 2 SVF treatments (high and low dose) and a placebo control.

Official Title
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Use of Autologous Adipose-Derived Stromal Vascular Fraction to Treat Osteoarthritis of the Knee: A Controlled, Randomized, Double-Blinded Trial

Conditions
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Osteoarthritis (OA)

Intervention / Treatment
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* Device: GID SVF-2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI. Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months. 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 will be in good health (ASA Class I-II) with a BMI < 35. Subjects must have continued pain in the knee despite conservative therapies for at least 3 months. Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain. Subjects must speak, read and understand English. Subjects must be reasonably able to return for multiple follow-up visits. Exclusion Criteria: Subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans. Subjects who have had surgery of either knee within 6 months prior to the screening visit. Subjects who have had a major injury to the targeted knee within 12 months prior to enrolling in the study. Subjects who have had an injection in either knee in the prior 3 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP). Subjects who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication. Subjects who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee. Subjects that are unwilling to stop taking prescription or over the counter pain medication for 7 days prior to any visit Subjects that are allergic to lidocaine, epinephrine or valium Subjects with a history of bleeding disorders, anticoagulation therapy that cannot be stopped as prior to injection. 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 Subjects that use any form of tobacco 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 of the targeted/treatment leg or adipose harvest site. Subjects currently on worker's compensation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: Low Dose SVF<br>This group of subjects will receive a low dose of SVF for treatment of knee OA. | Device: GID SVF-2<br>* The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.<br>|
| Experimental: High Dose<br>This group of subjects will receive a high dose of SVF for treatment of knee OA. | Device: GID SVF-2<br>* The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.<br>|
| Placebo Comparator: Placebo<br>This group of subjects will receive a placebo with no SVF Cells for treatment of knee OA. | Other: Placebo<br>* Placebo Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of Participants With Treatment-Emergent Serious Adverse Events | Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings. | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months | The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis. | baseline and 6 months |