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

Hwan Yoon Seung, Shik Shim Yu, Hoon Park Yong, Kwon Chung Jong, Hyun Nam Jung, Ok Kim Myung, Chun Park Hyung, Ra Park So, Byoung Hyun Min, Young Kim Eun, Hyune Choi Byung, Hyeonseon Park, Yoon Ha

Research output: Contribution to journalArticle

246 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2066-2073
Number of pages8
JournalStem Cells
Volume25
Issue number8
DOIs
Publication statusPublished - 2007 Aug 1

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Phase II Clinical Trials
Clinical Trials, Phase I
Granulocyte-Macrophage Colony-Stimulating Factor
Bone Marrow Transplantation
Spinal Cord Injuries
Bone Marrow
Wounds and Injuries
Magnetic Resonance Imaging
Neuralgia
Therapeutic Uses
Therapeutics
Decompression
Multicenter Studies
Cysts
Spinal Cord
Transplantation
Hemorrhage
Morbidity
Safety
Control Groups

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Developmental Biology
  • Cell Biology

Cite this

Seung, Hwan Yoon ; Yu, Shik Shim ; Yong, Hoon Park ; Jong, Kwon Chung ; Jung, Hyun Nam ; Myung, Ok Kim ; Hyung, Chun Park ; So, Ra Park ; Min, Byoung Hyun ; Eun, Young Kim ; Byung, Hyune Choi ; Park, Hyeonseon ; Ha, Yoon. / 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. In: Stem Cells. 2007 ; Vol. 25, No. 8. pp. 2066-2073.
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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.",
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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. / Seung, Hwan Yoon; Yu, Shik Shim; Yong, Hoon Park; Jong, Kwon Chung; Jung, Hyun Nam; Myung, Ok Kim; Hyung, Chun Park; So, Ra Park; Min, Byoung Hyun; Eun, Young Kim; Byung, Hyune Choi; Park, Hyeonseon; Ha, Yoon.

In: Stem Cells, Vol. 25, No. 8, 01.08.2007, p. 2066-2073.

Research output: Contribution to journalArticle

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T1 - Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor

T2 - Phase I/II clinical trial

AU - Seung, Hwan Yoon

AU - Yu, Shik Shim

AU - Yong, Hoon Park

AU - Jong, Kwon Chung

AU - Jung, Hyun Nam

AU - Myung, Ok Kim

AU - Hyung, Chun Park

AU - So, Ra Park

AU - Min, Byoung Hyun

AU - Eun, Young Kim

AU - Byung, Hyune Choi

AU - Park, Hyeonseon

AU - Ha, Yoon

PY - 2007/8/1

Y1 - 2007/8/1

N2 - 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.

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