Abstract
BackgroundAdipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. The goal of this study was to assess the safety and tolerability of a single intradiscal implantation of combined AT-MSCs and hyaluronic acid (HA) derivative in patients with chronic discogenic LBP.MethodsWe performed a single-arm phase I clinical trial with a 12-month follow-up and enrolled 10 eligible chronic LBP patients. Chronic LBP had lasted for more than 3 months with a minimum intensity of 4/10 on a visual analogue scale (VAS) and disability level ≥ 30% on the Oswestry Disability Index (ODI). The 10 patients underwent a single intradiscal injection of combined HA derivative and AT-MSCs at a dose of 2 × 107 cells/disc (n = 5) or 4 × 107 cells/disc (n = 5). Safety and treatment outcomes were evaluated by assessing VAS, ODI, Short Form-36 (SF-36), and imaging (lumbar spine X-ray imaging and MRI) at regular intervals over 1 year.ResultsNo patients were lost at any point during the 1-year clinical study. We observed no procedure or stem cell-related adverse events or serious adverse events during the 1-year follow-up period. VAS, ODI, and SF-36 scores significantly improved in both groups receiving both low (cases 2, 4, and 5) and high (cases 7, 8, and 9) cell doses, and did not differ significantly between the two groups. Among six patients who achieved significant improvement in VAS, ODI, and SF-36, three patients (cases 4, 8, and 9) were determined to have increased water content based on an increased apparent diffusion coefficient on diffusion MRI.ConclusionsCombined implantation of AT-MSCs and HA derivative in chronic discogenic LBP is safe and tolerable. However, the efficacy of combined AT-MSCs and HA should be investigated in a randomized controlled trial in a larger population.Trial registrationClinicalTrials.gov NCT02338271. Registered 7 January 2015.
Highlights
Adipose tissue-derived mesenchymal stem cells (AT-Mesenchymal stem cell (MSC)) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation
We investigated safety issues and treatment outcomes for combined implantation of Adipose tissue-derived mesenchymal stem cell (AT-MSC) and hyaluronic acid (HA) derivative using a visual analogue scale (VAS), the Oswestry Disability Index (ODI), Short Form-36 (SF-36), and imaging techniques such as lumbar spine X-ray imaging and magnetic resonance imaging (MRI) in patients with chronic discogenic LBP refractory to conventional treatments
AT-MSCs combined with HA derivative were implanted into the L4/5 disc in nine patients
Summary
Adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic low back pain (LBP) because of their immunomodulatory functions and capacity for cartilage differentiation. Chronic low back pain (LBP) is one of the leading causes of disability and has an enormous social and economic impact on patients and their family members [1, 2]. IVD degeneration is characterized by progressive decline in nucleus pulposus (NP) hydration due to the loss of extracellular matrix (ECM) molecules such as aggrecan and collagen [2, 8]. This decreased disc hydration results in a loss of mechanical tension in the collagen fibers of the annulus fibrosus and results in abnormal spinal axial loading forces and segmental instability [9]. Repair or arrest of disc degeneration in the early stages might prevent these more serious sequelae
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