StemSpine™ : Autologous paraspinal administration of bone marrow aspirate for treatment of lower back pain caused by lumbar angina

Background : Chronic lower back pain caused by degenerative disc disease (DDD) is a significant cause of morbidity and mortality, which is currently treated by surgical means such as fusion, or mechanical means such as artificial discs. Only a minority of patients with DDD are eligible for these procedures and in numerous cases they require re-intervention. Cell therapy has been utilized for many spine-based procedures with mixed results. Our goal was to evaluate cell therapy in the treatment of non-surgical DDD. Aim : To perform a pilot study using autologous bone marrow aspirate for treatment of non-surgical, chronic lower back pain. Methods : In this prospective, observational cohort study, fifteen patients between 18 and 85 years of age with the diagnosis of non-surgical chronic lower back pain were enrolled to receive paraspinal injections of autologous bone marrow aspirate. In order to qualify, patients must have been diagnosed with degenerative disease in one, two, or three lumbar discs with predominant back pain after having failed conservative treatment including optimized physical therapy for over 6 months. Patients with surgical back pain as determined by a neuro-specialist, spinal deformity, or spinal instability were all disqualified from participating. All enrolled patients underwent outpatient bone marrow aspiration using the Marrow Cellutions kit. The aspirate was then injected into the paraspinal area using image guidance via ultrasound with each patient having an average of six injections. The patients were then followed at 30, 60, 90, 180, 360, and 720 days. The Oswestry Disability Index and Visual Analogue Scale were used to objectively assess for any change in the patient's mobility and back pain post procedure. Results : Fourteen of the fifteen patients had injections near the L4, L5, and/or S1 region bilaterally. Evaluation of patients at 1, 30, 90, 180, 360, and 720 days revealed significant improvement in mobility using the Oswestry Disability Index and reduction in pain score using the Visual Analogue Scale. The mean pain score changed from 8.9 at baseline to 4.3 at 30 days and sustained to 1.8 at 6 months, 1.3 at 12 months and 2.2 at 24 months with a gradual reduction in overall pain medication utilization guided by their healthcare team. Two patients at the 24-month time point had recurrence of symptoms without significant MRI changes, and opted to be treated with medical therapy. They both had pain scores back up to 5 and an Oswestry score of 30 and 32 respectively. There was some short-term bruising in two patients at the harvest site and no long-term adverse events were reported related to the procedure. Overall, the procedure was safely performed on 15/15 patients (100%) and 13/15 patients (87%) still had durable results at two years. Conclusion : This data supports the further investigation of paraspinal administration of non-manipulated autologous bone marrow aspirate for reducing pain and improving mobility in patients with non-surgical lower back pain.