Safety and Efficacy of Injection of Adipose-derived Regenerative Cells (ADRCs) in Patients Suffering From Osteoarthritis of the Facet Joints
This is a prospective, randomized, active controlled, single site safety and efficacy study in subjects suffering from chronic lumber back pain due to facet joint osteoarthritis comparing a single ADRC injection generated with the Transpose® RT system into the facet joint.
• Male and female subjects, between 18 and 75 years of age.
• Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator.
• Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions):
‣ Chronic low back pain for at least 6 months.
⁃ Have failed 3 months of conservative back pain care. (Conservative treatment regimens may include any or all of the following: initial rest, medications \[e.g., anti-inflammatory, analgesics, narcotics/opioids, muscle relaxants\], massage, acupuncture, chiropractic manipulations, activity modification, home-directed lumbar exercise program, and non- invasive pain control treatments or procedures).
⁃ Have undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain.
⁃ Change from normal spine morphology at the symptomatic level as defined by Radiographic evaluation for Lumbar facet joint osteoarthritis.
⁃ The baseline pain score of at least 4 on a pain scale of 0-10, over 24 hours
• Subjects demonstrate \>80% relief of their pain after diagnostic injection.
• Signed informed consent indicating the subject is willing to undergo treatment and willing to be available for each examination scheduled over the study duration