Hirota Ryosuke, Sasaki Masanori, Iyama Satoshi, Kurihara Kota, Fukushi Ryunosuke, Obara Hisashi, Oshigiri Tsutomu, Morita Tomonori, Nakazaki Masahito, Namioka Takahiro, Namioka Ai, Onodera Rie, Kataoka-Sasaki Yuko, Oka Shinichi, Takemura Mitsuhiro, Ukai Ryo, Yokoyama Takahiro, Sasaki Yuichi, Yamashita Tatsuro, Kobayashi Masato, Okuma Yusuke, Kondo Reiko, Aichi Ryo, Ohmatsu Satoko, Kawashima Noritaka, Ito Yoichi M, Kobune Masayoshi, Takada Kohichi, Ishiai Sumio, Ogata Toru, Teramoto Atsushi, Yamashita Toshihiko, Kocsis Jeffery D, Honmou Osamu
Department of Orthopaedic Surgery, School of Medicine, Sapporo Medical University, Sapporo 060-8556, Japan.
Department of Neural Regenerative Medicine, Institute of Regenerative Medicine, School of Medicine, Sapporo Medical University, Sapporo 060-8556, Japan.
J Clin Med. 2024 Oct 11;13(20):6072. doi: 10.3390/jcm13206072.
The safety, feasibility, and potential functional improvement following the intravenous infusion of mesenchymal stem cells (MSCs) were investigated in patients with chronic severe spinal cord injury (SCI). The intravenous infusion of autologous MSCs cultured in auto-serum under Good Manufacturing Practices (GMP) was administered to seven patients with chronic SCI (ranging from 1.3 years to 27 years after the onset of SCI). In addition to evaluating feasibility and safety, neurological function was evaluated using the American Spinal Injury Association Impairment Scale (AIS), International Standards for Neurological Classification of Spinal Cord Injury (ISCSCI-92), and Spinal Cord Independence Measure III (SCIM-III). No serious adverse events occurred. Neither CNS tumors, abnormal cell growth, nor neurological deterioration occurred in any patients. While this initial case series was not blinded, significant functional improvements and increased quality of life (QOL) were observed at 90 and 180 days post-MSC infusion compared to pre-infusion status. One patient who had an AIS grade C improved to grade D within six months after MSC infusion. This case series suggests that the intravenous infusion of autologous MSCs is a safe and feasible therapeutic approach for chronic SCI patients. Furthermore, our data showed significant functional improvements and better QOL after MSC infusion in patients with chronic SCI. A blind large-scale study will be necessary to fully evaluate this possibility.
在慢性严重脊髓损伤（SCI）患者中，研究了静脉输注间充质干细胞（MSC）后的安全性、可行性以及潜在的功能改善情况。在良好生产规范（GMP）条件下，将自体血清中培养的自体MSC静脉输注给7例慢性SCI患者（SCI发病后1.3年至27年）。除了评估可行性和安全性外，还使用美国脊髓损伤协会损伤量表（AIS）、脊髓损伤神经分类国际标准（ISCSCI - 92）和脊髓独立测量III（SCIM - III）对神经功能进行评估。未发生严重不良事件。所有患者均未出现中枢神经系统肿瘤、异常细胞生长或神经功能恶化。虽然这个初始病例系列没有设盲，但与输注前状态相比，在MSC输注后90天和180天时观察到了显著的功能改善和生活质量（QOL）提高。1例AIS分级为C级的患者在MSC输注后6个月内改善为D级。该病例系列表明，自体MSC静脉输注对慢性SCI患者是一种安全可行的治疗方法。此外，我们的数据显示，慢性SCI患者在MSC输注后功能有显著改善，QOL也更好。有必要进行一项盲法大规模研究来全面评估这种可能性。
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