• Sun Kyu Oh, Kyoung Hyo Choi, Jong Yoon Yoo, Dae Yul Kim, Sang Joon Kim, and Sang Ryong Jeon.
• Departments of *Neurological Surgery,‡Rehabilitation Medicine, and§Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
• Neurosurgery. 2016 Mar 1; 78 (3): 436-47; discussion 447.

BackgroundIn our previous report, 3 of 10 patients with spinal cord injury who were injected with autologous mesenchymal stem cells (MSCs) showed motor improvement in the upper extremities and in activities of daily living.ObjectiveTo report on the results of a phase III clinical trial of autologous MSCs therapy.MethodsPatients were selected based on the following criteria: chronic American Spinal Injury Association B status patients who had more than 12 months of cervical injury, and no neurological changes during the recent 3 months of vigorous rehabilitation. We injected 1.6 × 10 autologous MSCs into the intramedullary area at the injured level and 3.2 × 10 autologous MSCs into the subdural space. Outcome data were collected over 6 months regarding neurological examination, magnetic resonance imaging with diffusion tensor imaging, and electrophysiological analyses.ResultsAmong the 16 patients, only 2 showed improvement in neurological status (unilateral right C8 segment from grade 1 to grade 3 in 1 patient and bilateral C6 from grade 3 to grade 4 and unilateral right C8 from grade 0 to grade 1 in 1 patient). Both patients with neurological improvement showed the appearance of continuity in the spinal cord tract by diffusion tensor imaging. There were no adverse effects associated with MSCs injection.ConclusionSingle MSCs application to intramedullary and intradural space is safe, but has a very weak therapeutic effect compared with multiple MSCs injection. Further clinical trials to enhance the effect of MSCs injection are necessary.

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