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

Summary

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.

Qualifications:

Criteria:

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

Exclusion Criteria:*

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

In order to see if you could be a candidate for this clinical trial or if you have any further questions, please fill out this form and a representative will be contacting you shortly.

*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

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