Stem Cells vs. Steroids for Discogenic Back Pain

Summary

Participation Requirements

Description

In this study, the investigators are attempting to determine if intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BMC) will decrease pain and improve function compared with intradiscal steroids. Up to 106 patients with a clinical diagnosis of chronic discogenic low back...

In this study, the investigators are attempting to determine if intradiscal injection of autologous bone marrow-derived mesenchymal stem cells (BMC) will decrease pain and improve function compared with intradiscal steroids. Up to 106 patients with a clinical diagnosis of chronic discogenic low back pain for greater than 6 months, MRI evidence of lumbar disc degeneration limited to one or two discs with <50% disc height loss, and positive provocative discography (if clinically indicated) will be randomized to receive intradiscal BMC or steroid and long-acting local anesthetic (bupivacaine). Those randomized to group I will receive a 2 mL intradiscal injection of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium, while those randomized to group II will receive an intradiscal injection of the steroid methylprednisolone and the local anesthetic bupivacaine. The first follow-up will occur at 4-weeks post-treatment at which time rescue medications may be prescribed or adjusted but no other analgesic interventions should occur. The primary outcome measure will be pain relief at 3 months post-treatment, while a positive categorical outcome will be a 2-point or greater decrease in average LBP coupled with either a score > 5/7 on the PGIC (indicating noticeable improvement) or a 10-point decrease in ODI (indicating a clinically meaningful benefit). At 3 months, a repeat MRI will be obtained in selected patients at military treatment facilities (i.e. every 5th patient). Those who fail to experience a positive categorical outcome will be withdrawn from the study to receive alternate care, including an option for intradiscal BMC in those who received corticosteroid. For those who continue to experience a positive outcome, there will be 6- and 12-month follow up visits. At all follow-up visits, histories and physical exams will be performed and questionnaires assessing sleep, function, and anxiety and depression will be administered.

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