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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

This 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.

Key facts

Study ID: NCT04440189
Run by: GID BIO, Inc.
People needed: 114
Starts: 2020-10-15
Expected to finish: 2025-06-30
Last updated by the study team: 2025-04-23

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 4.0 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

You may not qualify if…

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 4.0 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

Where it is running

UC Davis — Sacramento, California, United States
Advanced Research LLC — Coral Springs, Florida, United States
Tulane University — New Orleans, Louisiana, United States
New Jersey Regenerative Institute — Cedar Knolls, New Jersey, United States
OrthoCarolina Research Institute — Charlotte, North Carolina, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Ohio State University Jameson Crane Sports Medicine Institute — Columbus, Ohio, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Texas Center for Cell Therapy and Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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