GID BIO for Knee Osteoarthritis Study
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
GID BIO has selected New Jersey Regenerative Institute for as a site for its FDA-compliant clinical trial measuring the safety and efficacy of its cellular therapy for knee osteoarthritis. Participants in the clinical trial will undergo an out-patient treatment:
- A physician harvests a small amount of fat tissue from a patient’s abdominal or gluteal region under local anesthetic.
- Using GID’s SVF-2 technology platform, the participant’s own stromal cells are isolated and concentrated into a cellular implant.
- The cellular implant is injected into the knee under image guidance for precise placement and characterization.
Some participants will receive a placebo injection.
This cellular therapy has been tested in a previous FDA-compliant clinical trial in which 88% percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function.
Costs:The study is free and participants will be compensated for their time.
- Male and Females 35-85 years old
- Subjects with a Body Mass Index between 22 to 37
- Subjects must be willing to give written Informed Consent to participate and sign the HIPAA authorization
- Have bilateral or unilateral knee osteoarthritis
- Index knee must present with a score ≥8 using the WOMAC pain scale (A1 subscale, 20 total points)
- Speak, read and understand English
- Be able to return for multiple follow-up visits
- Knee pain caused by meniscus injuries, displaced meniscus tear, acute ligament tears, cartilage thickness (greater than 1.5 cm in any direction), pain due to patellar mal-tracking or dislocations, Osteo chondritis dissecans, Edema, Hoffa’s Pad Syndrome, Baker’s/Ganglion/Parameniscal Cysts, Lipoma arborescens
- Outerbridge Scale Grade I diagnosed on MRI
- Outerbridge Scale Grade IV (full thickness lesion of articular cartilage greater than 1.5cm) diagnosed on MRI
- Knee surgery (either knee) within the last 6 months
- Major knee injury (either knee) within last 12 months
- Injection in either knee in last 6 months including corticosteroids, viscosupplementation, SVF, BMAC or PRP
- 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
- Allergic to Lidocaine, Epinephrine or Valium
- Unwilling to stop taking prescription or over the counter pain medication 7 days prior
- A history of bleeding disorders or anticoagulation therapy that cannot be stopped as follows prior to injection
- Systemic immunosuppressant use with 6 weeks from screening who have HIV or viral hepatitis
- Have chondrocalcinosis, Paget's disease or Villonodular synovitis
- Tobacco users that smoke once a week over most recent 1 year period (includes e-cigarettes)
- Women that are pregnant or planning to become pregnant
- Long term use of oral steroids
- History of Chemo or Radiation therapy on either leg or adipose harvest site
- On worker’s compensation
*Garza, J. R., R. E. Campbell, F. P. Tjoumakaris, K. B. Freedman, L. S. Miller, D. Santa Maria and B. S. Tucker, 2020: Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial. The American journal of sports medicine, 48, 588-598