InGeneron, Inc.
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.
Patients will fall into two categories: treatment group (20 subjects) and non-treatment or control group (20 subjects). The treatment group will undergo a small liposuction procedure and receive facet joint osteoarthritis treatment with an ultrasound-guided injection of 5 ml adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5 ml corticosteroid injection into the point of injury
Inclusion Criteria: 1. Male and female subjects, between 18 and 75 years of age. 2. Have documented the diagnosis of facet joint osteoarthritis from L1 to S1 in the opinion of the investigator. 3. Have a documented diagnosis of symptomatic facet joint syndrome is defined as the following (subject must meet all the listed conditions): 1. Chronic low back pain for at least 6 months. 2. 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/opi…
ADRC injection into the facet joint
Corticosteroid injection into the facet joint
Arctuva estimate
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