Complete Spinal Cord Injury Treatment Using Autologous Bone Marrow Cell Transplantation and Bone Marrow Stimulation with Granulocyte Macrophage-Colony Stimulating Factor: Phase I/II Clinical Trial

Authors

  • Seung Hwan Yoon,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
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  • Yu Shik Shim,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
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  • Yong Hoon Park,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Inha Research Institute for Medical Sciences
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  • Jong Kwon Chung,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Anesthesiology, Inha University College of Medicine, Incheon, Korea
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  • Jung Hyun Nam,

    1. Diagnostic Pathology, Inha University College of Medicine, Incheon, Korea
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  • Myung Ok Kim,

    1. Rehabilitation Medicine, Inha University College of Medicine, Incheon, Korea
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  • Hyung Chun Park,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
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  • So Ra Park,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Physiology, Inha University College of Medicine, Incheon, Korea
    3. Center for Advanced Medical Education by BK21 Project, Inha University College of Medicine, Incheon, Korea
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  • Byoung-Hyun Min,

    1. Department of Orthopedics, Molecular Science, and Technology, Ajou University Hospital, Suwon, Korea
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  • Eun Young Kim,

    1. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
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  • Byung Hyune Choi,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Inha Research Institute for Medical Sciences
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  • Hyeonseon Park,

    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
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  • Yoon Ha M.D., Ph.D.

    Corresponding author
    1. Inha Neural Repair Center, Inha University College of Medicine, Incheon, Korea
    2. Departments of Neurosurgery, Inha University College of Medicine, Incheon, Korea
    3. Center for Advanced Medical Education by BK21 Project, Inha University College of Medicine, Incheon, Korea
    • Department of Neurosurgery, Inha University College of Medicine, 7-206, Sinheung-dong 3-ga, Jung-gu, Incheon 400-712, Korea. Telephone: +82-32-890-3449; Fax: +82-32-890-3099
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Abstract

To assess the safety and therapeutic efficacy of autologous human bone marrow cell (BMC) transplantation and the administration of granulocyte macrophage-colony stimulating factor (GM-CSF), a phase I/II open-label and nonrandomized study was conducted on 35 complete spinal cord injury patients. The BMCs were transplanted by injection into the surrounding area of the spinal cord injury site within 14 injury days (n = 17), between 14 days and 8 weeks (n = 6), and at more than 8 weeks (n = 12) after injury. In the control group, all patients (n = 13) were treated only with conventional decompression and fusion surgery without BMC transplantation. The patients underwent preoperative and follow-up neurological assessment using the American Spinal Injury Association Impairment Scale (AIS), electrophysiological monitoring, and magnetic resonance imaging (MRI). The mean follow-up period was 10.4 months after injury. At 4 months, the MRI analysis showed the enlargement of spinal cords and the small enhancement of the cell implantation sites, which were not any adverse lesions such as malignant transformation, hemorrhage, new cysts, or infections. Furthermore, the BMC transplantation and GM-CSF administration were not associated with any serious adverse clinical events increasing morbidities. The AIS grade increased in 30.4% of the acute and subacute treated patients (AIS A to B or C), whereas no significant improvement was observed in the chronic treatment group. Increasing neuropathic pain during the treatment and tumor formation at the site of transplantation are still remaining to be investigated. Long-term and large scale multicenter clinical study is required to determine its precise therapeutic effect.

Disclosure of potential conflicts of interest is found at the end of this article.

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