Document Detail

Neuroprotective therapy using granulocyte colony-stimulating factor for acute spinal cord injury: a phase I/IIa clinical trial.
MedLine Citation:
PMID:  22391867     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: Granulocyte colony-stimulating factor (G-CSF) is a cytokine that is clinically used to treat neutropenia. G-CSF also has non-hematopoietic functions and could potentially be used to treat neuronal injury. To confirm the safety and feasibility of G-CSF administration for acute spinal cord injury (SCI), we have initiated a phase I/IIa clinical trial of neuroprotective therapy using G-CSF.
METHODS: The trial included a total of 16 SCI patients within 48 h of onset. In the first step, G-CSF (5 μg/kg/day) was intravenously administered for 5 consecutive days to 5 patients. In the second step, G-CSF (10 μg/kg/day) was similarly administered to 11 patients. We evaluated motor and sensory functions of patients using the American Spinal Cord Injury Association (ASIA) score and ASIA impairment scale (AIS) grade.
RESULTS: In all 16 patients, neurological improvement was obtained after G-CSF administration. AIS grade increased by one step in 9 of 16 patients. A significant increase in ASIA motor scores was detected 1 day after injection (P < 0.01), and both light touch and pin prick scores improved 2 days after injection (P < 0.05) in the 10 μg group. No severe adverse effects were observed after G-CSF injection.
CONCLUSION: These results indicate that intravenous administration of G-CSF (10 μg/kg/day) for 5 days is essentially safe, and suggest that some neurological recovery may occur in most patients. We suggest that G-CSF administration could be therapeutic for patients with acute SCI.
Hiroshi Takahashi; Masashi Yamazaki; Akihiko Okawa; Tsuyoshi Sakuma; Kei Kato; Mitsuhiro Hashimoto; Koichi Hayashi; Takeo Furuya; Takayuki Fujiyoshi; Junko Kawabe; Tomonori Yamauchi; Chikato Mannoji; Tomohiro Miyashita; Ryo Kadota; Masayuki Hashimoto; Yasuo Ito; Kazuhisa Takahashi; Masao Koda
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-03-06
Journal Detail:
Title:  European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society     Volume:  21     ISSN:  1432-0932     ISO Abbreviation:  Eur Spine J     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-11-28     Completed Date:  2013-06-28     Revised Date:  2013-12-08    
Medline Journal Info:
Nlm Unique ID:  9301980     Medline TA:  Eur Spine J     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  2580-7     Citation Subset:  IM    
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MeSH Terms
Granulocyte Colony-Stimulating Factor / therapeutic use*
Middle Aged
Neuroprotective Agents / therapeutic use*
Recovery of Function / drug effects*
Spinal Cord Injuries / drug therapy*
Reg. No./Substance:
0/Neuroprotective Agents; 143011-72-7/Granulocyte Colony-Stimulating Factor

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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