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. 2024 Oct 11;13(20):6072.
doi: 10.3390/jcm13206072.

Intravenous Infusion of Autologous Mesenchymal Stem Cells Expanded in Auto Serum for Chronic Spinal Cord Injury Patients: A Case Series

Ryosuke Hirota  1   2   3 , Masanori Sasaki  2   3   4 , Satoshi Iyama  5 , Kota Kurihara  1   2 , Ryunosuke Fukushi  1   2 , Hisashi Obara  1   2 , Tsutomu Oshigiri  1 , Tomonori Morita  1   2 , Masahito Nakazaki  2   3 , Takahiro Namioka  2 , Ai Namioka  2 , Rie Onodera  2 , Yuko Kataoka-Sasaki  2   4 , Shinichi Oka  2   4 , Mitsuhiro Takemura  2 , Ryo Ukai  2 , Takahiro Yokoyama  2 , Yuichi Sasaki  2   6 , Tatsuro Yamashita  2   6 , Masato Kobayashi  2   6 , Yusuke Okuma  7 , Reiko Kondo  7 , Ryo Aichi  7 , Satoko Ohmatsu  7 , Noritaka Kawashima  7 , Yoichi M Ito  8 , Masayoshi Kobune  5 , Kohichi Takada  9 , Sumio Ishiai  6 , Toru Ogata  10 , Atsushi Teramoto  1 , Toshihiko Yamashita  1 , Jeffery D Kocsis  3   11 , Osamu Honmou  2   3   4
Affiliations

Intravenous Infusion of Autologous Mesenchymal Stem Cells Expanded in Auto Serum for Chronic Spinal Cord Injury Patients: A Case Series

Ryosuke Hirota et al. J Clin Med. .

Abstract

Objective: 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). Methods: 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). Results: 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. Conclusions: 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.

Keywords: case series; chronic; clinical trials; intravenous; mesenchymal stem cell; spinal cord injury.

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Conflict of interest statement

The Department of Advanced Regenerative Therapeutics at Sapporo Medical University has been endowed by the NIPRO Corporation since 1st February 2014. Sapporo Medical University and NIPRO Corporation have entered into a joint research and development agreement since 1st April 2014, which provides research support to the Department, including work carried out by some of the co-authors (M. Sasaki, M. Nakazaki, Y. Kataoka-Sasaki, S. Oka and O. Honmou). R. Hirota, T. Morita, M. Nakazaki and J. D. Kocsis received research support through Yale University from NIPRO Corporation on pre-clinical studies of rodent MSCs in animal models. R. Hirota, M. Sasaki, S. Oka, R. Fukushi, T. Ogata, A. Teramoto, T. Yamashita and O. Honmou received honoraria from NIPRO Corporation. S. Iyama, K. Kurihara, H. Obara, T. Oshigiri, T. Namioka, A. Namioka, R. Onodera, M. Takemura, R. Ukai, T. Yokoyama, Y. Sasaki, Tatsuro Yamashita, M. Kobayashi, Y. Okuma, R. Kondo, R. Aichi, S. Ohmatsu, N. Kawashima, Y. M. Ito, M. Kobune, K. Takada, S. Ishiai report no competing interests on this study.

Figures

Figure 1
Figure 1
Clinical protocol.
Figure 2
Figure 2
Case 1. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 3
Figure 3
Case 2. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 4
Figure 4
Case 3. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 5
Figure 5
Case 4. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 6
Figure 6
Case 5. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 7
Figure 7
Case 6. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 8
Figure 8
Case 7. T2-weighted MRI. (A) Sagittal arrows indicate the high-intensity areas. (B) Axial images. The arrowhead indicates the high-intensity areas. (C) Sensory function (pre, post 6M), (D) motor function, (E) sensory function, and (F) SCIM-III score.
Figure 9
Figure 9
Outcome measure scores according to AIS C classification ((A): motor; (B): sensory; (C): SCIM-III) prior to MSC infusion, 90 and 180 days post-MSC infusion.
Figure 10
Figure 10
Comparison of outcome measure scores before infusion and six months post-MSC infusion based on AIS classification ((A,D): motor; (B,E): sensory; (C,F): SCIM-III).
See this image and copyright information in PMC

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