GID BIO FOR KNEE OSTEOARTHRITIS STUDY

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Research Topics

• GID BIO for Knee Osteoarthritis
• Knee Osteoarthritis
• Sciatica
• Partial Thickness Rotator Cuff Tear

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

Articles:

• Tulane knee pain study begins, looks for participants
• Colorado biotech firm's new cell therapy could eliminate the need for knee replacements

GID BIO FOR KNEE OSTEOARTHRITIS STUDYLearn More AboutYour DoctorRequest AnAppointmentResearch TopicsGID BIO for Knee OsteoarthritisKnee OsteoarthritisSciaticaPartial Thickness Rotator Cuff TearUse 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 StudySummaryGID BIO has z Dselected 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 oldSubjects with a Body Mass Index between 22 to 37Subjects 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 EnglishBe able to return for multiple follow-up visitsExclusion 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 arborescensOuterbridge Scale Grade I diagnosed on MRIOuterbridge Scale Grade IV (full thickness lesion of articular cartilage greater than 1.5cm) diagnosed on MRIKnee surgery (either knee) within the last 6 monthsMajor knee injury (either knee) within last 12 monthsInjection in either knee in last 6 months including corticosteroids, viscosupplementation, SVF, BMAC or PRPHave 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 claudicationAllergic to Lidocaine, Epinephrine or ValiumUnwilling to stop taking prescription or over the counter pain medication 7 days priorA history of bleeding disorders or anticoagulation therapy that cannot be stopped as follows prior to injectionSystemic immunosuppressant use with 6 weeks from screening who have HIV or viral hepatitisHave chondrocalcinosis, Paget's disease or Villonodular synovitisTobacco users that smoke once a week over most recent 1 year period (includes e-cigarettes)Women that are pregnant or planning to become pregnantLong term use of oral steroidsHistory of Chemo or Radiation therapy on either leg or adipose harvest siteOn worker’s compensationIn 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 Articles:Tulane knee pain study begins, looks for participantsColorado biotech firm's new cell therapy could eliminate the need for knee replacements