Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis
Purpose
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.
Condition
- Osteoarthritis, Knee
Eligibility
- Eligible Ages
- Between 35 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 1.5 cm in any direction - 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
Exclusion Criteria
- Subjects whose knee pain is caused by: - unstable meniscal root tears or locked bucket handle meniscal tears - displaced meniscus tear - full thickness lesion of the articular cartilage greater than 1.5 cm in any direction - osteo chondritis dissecans - parameniscal, Baker's, or ganglion cysts - lipoma arborescens - Hoffa's Pad Syndrome - acute ligament tears - diffuse edema - pain due to patellar mal-tracking or patellar dislocations - Outerbridge Scale Grade I as diagnosed on MRI - Outerbridge Scale Grade IV where the full thickness lesion of the articular cartilage is greater than 1.5 cm in any direction, as diagnosed on MRI - 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 in 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 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 that are unwilling to stop taking prescription or over the counter pain medication 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 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, Xeralta® (rivaroxaban) for 24 hours - Subjects with systemic immunosuppressant use within 6 weeks from screening and subjects with HIV or viral hepatitis - Subjects with 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 use of oral steroids - History of any chemotherapy or radiation therapy on either leg or adipose harvest site - Subjects currently on worker's compensation
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Subjects will receive an injection of Lactated Ringers in their index knee |
|
|
Experimental Stromal Vascular Fraction (SVF) |
Subjects will receive an injection of Stromal Vascular Fraction in their index knee |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- GID BIO, Inc.
Detailed Description
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).