Spinal cord injury treatment with intrathecal autologous bone marrow stromal cell transplantation: the first clinical trial case report.

Abstract

Spinal cord injury often results in devastating dysfunction and disability. When a spinal cord is injured, various symptoms are presented depending on the segments of the damage and the degree. If cervical spinal damage is severe, tetraplegia results. If damage occurs at levels higher than C4, diaphragmatic movement will be impaired, and the patient has to live being connected with the ventilator on the bed. Patients will suffer from acute hyperesthesia or severe chronic pain, urinary and rectal dysfunction, and autonomic dystonia as well as motor and sensory deficits. In Japan, there are more than 100,000 victims suffering from spinal injury, and a new 5,000 to 6,000 patients are added every year. In the Unites States, about 250,000 to 400,000 people are living with spinal cord injury, and there are about 11,000 to 13,000 new injuries every year. The number of incidence is increasing. The majority of them result from motor vehicle or sports injuries, violence, or falls. An injured central nervous system never regenerates. This has long been thought as a medical common sense terms. Therefore, the principal object for the treatment of spinal injury was mainly purposed how to minimize the progression of secondary injuries and maintain the remnant function of the spine. For the purpose of preventing secondary spinal cord injury, spine stabilization for the fracture or dislocation and rehabilitation were the main strategy in the treatment. There has been no successful treatment for the severe spinal cord injury to recover the function satisfactorily. However, if spinal cord damage is functionally improved even at the minimum, it will affect not only the physical, mental, and economic status of patients and their families, but also the medical resources of society. Recently, regenerative treatments with stem cells are in the limelight. However, there are some serious problems such as ethical ones to be solved for the study with stem cells. We reported significant recovery of motor function in rats with experimental spinal cord injury treated by transplanting bone marrow stromal cells (BMSCs) in the cerebrospinal fluid (CSF). Based on that study, we aimed at the clinical application of this treatment, and actually planned a clinical trial of spinal cord injury treatment by transplanting patient’s autologous BMSCs into CSF in the acute phase after spinal cord injury, at Kansai Medical University Hospital. We have developed a detailed protocol for the clinical trial. The medical ethics committees of the institutions have approved the protocol officially. This clinical trial aims to treat a damaged spinal cord by a novel method of injecting BMSCs into CSF through the lumbar puncture, and assess the safety and efficacy of the procedure. Although we have experienced only a single case, a committee that monitors the data to assess the efficacy and safety of the trial with members independent of this study team has evaluated the safety of the trial in this case, approved to continue the study, and agreed to submit a report of the first case. In addition, Japan Spinal Cord Foundation strongly requested to disclose the course of the first case. Therefore, we would like to publish the report of the first case to enhance research work on the new strategy for the difficult treatment of spinal cord injury. Submitted for publication July 6, 2007. Accepted for publication September 18, 2007. Copyright © 2008 by Lippincott Williams & Wilkins From the Emergency and Critical Care Center (F.S., T.N., M.I., Y.M., A.H., Y.M.), Kansai Medical University, Osaka, Japan; Department of Plastic and Reconstructive Surgery (Y.S.), Kitano Hospital, Tazuke Research Institute, Osaka, Japan; Department of Clinical Trial Design and Management (R.O., M.F.), Translational Research Center, Kyoto University Hospital, Kyoto, Japan; Department of Occupational Therapy (C.I.), Faculty of Nursing and Rehabilitation, Aino University, Osaka, Japan. This work was supported, in part, by a Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science, Japan. Presented in part at the 8th Asian Pacific Conference on Disaster Medicine, November 22, 2006, Tokyo, Japan; at the Shanghai International Conference on Trauma and Emergency Medicine, May 13, 2006, Shanghai, China; and as a poster at the 66th Annual Meeting of the American Association for the Surgery of Trauma, September 27–29, 2007, Las Vegas, Nevada. Address for reprints: Toshio Nakatani, MD, Emergency and Critical Care Center, Kansai Medical University, Osaka, Japan; email: nakatant@ takii.kmu.ac.jp.

DOI: 10.1097/TA.0b013e31815b847d

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@article{Saito2008SpinalCI, title={Spinal cord injury treatment with intrathecal autologous bone marrow stromal cell transplantation: the first clinical trial case report.}, author={Fukuki Saito and Toshio Nakatani and Masaaki Iwase and Yuji Maeda and Akihiko Hirakawa and Yoshinori Murao and Yoshihisa Suzuki and Rie Onodera and Masanori Fukushima and Chizuka Ide}, journal={The Journal of trauma}, year={2008}, volume={64 1}, pages={53-9} }