This is a single-blind, randomized, placebo-controlled study using platelet-based treatment to the functional spinal unit .in a series of 2 treatments 4 weeks apart to treat painful lumbar degenerative disc disease. Randomization is 2:1, with 28 in the treatment group and 14 in the sham control group.~A pretreatment visit will occur at or before the time of enrollment; follow-up visits will occur at the clinical site at 3- and 12 months post injection. Target enrollment is 42 subjects. Patients in the control group can crossover to the treatment group after 3-month follow-up. Crossover patients then follow the treatment group follow-up timeline based on their second real treatment. Subjects will complete the study following the 1-year follow-up visit.~The primary objective of this study is to observe the improvement in subject-reported clinical outcomes from baseline to 3 months after 2nd treatment and between groups at 3 months, with continued evaluation of efficacy and durability up to 12 months. Questionnaires are completed at 1, 3, 6, and 12 months.
To evaluate and compare two platelet-based treatments of the functional spinal unit spaced 4 weeks apart to sham procedures for the treatment of degenerative disc disease.