PMID- 22391867
OWN - NLM
STAT- MEDLINE
DCOM- 20130628
LR  - 20211021
IS  - 1432-0932 (Electronic)
IS  - 0940-6719 (Print)
IS  - 0940-6719 (Linking)
VI  - 21
IP  - 12
DP  - 2012 Dec
TI  - Neuroprotective therapy using granulocyte colony-stimulating factor for acute 
      spinal cord injury: a phase I/IIa clinical trial.
PG  - 2580-7
LID - 10.1007/s00586-012-2213-3 [doi]
AB  - 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 mug/kg/day) was intravenously administered for 5 
      consecutive days to 5 patients. In the second step, G-CSF (10 mug/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 mug group. No severe 
      adverse effects were observed after G-CSF injection. CONCLUSION: These results 
      indicate that intravenous administration of G-CSF (10 mug/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.
FAU - Takahashi, Hiroshi
AU  - Takahashi H
AD  - Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate 
      School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan.
FAU - Yamazaki, Masashi
AU  - Yamazaki M
FAU - Okawa, Akihiko
AU  - Okawa A
FAU - Sakuma, Tsuyoshi
AU  - Sakuma T
FAU - Kato, Kei
AU  - Kato K
FAU - Hashimoto, Mitsuhiro
AU  - Hashimoto M
FAU - Hayashi, Koichi
AU  - Hayashi K
FAU - Furuya, Takeo
AU  - Furuya T
FAU - Fujiyoshi, Takayuki
AU  - Fujiyoshi T
FAU - Kawabe, Junko
AU  - Kawabe J
FAU - Yamauchi, Tomonori
AU  - Yamauchi T
FAU - Mannoji, Chikato
AU  - Mannoji C
FAU - Miyashita, Tomohiro
AU  - Miyashita T
FAU - Kadota, Ryo
AU  - Kadota R
FAU - Hashimoto, Masayuki
AU  - Hashimoto M
FAU - Ito, Yasuo
AU  - Ito Y
FAU - Takahashi, Kazuhisa
AU  - Takahashi K
FAU - Koda, Masao
AU  - Koda M
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20120306
PL  - Germany
TA  - Eur Spine J
JT  - 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
JID - 9301980
RN  - 0 (Neuroprotective Agents)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Female
MH  - Granulocyte Colony-Stimulating Factor/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuroprotective Agents/*therapeutic use
MH  - Recovery of Function/*drug effects
MH  - Spinal Cord Injuries/*drug therapy
PMC - PMC3508205
EDAT- 2012/03/07 06:00
MHDA- 2013/07/03 06:00
PMCR- 2013/12/01
CRDT- 2012/03/07 06:00
PHST- 2011/08/18 00:00 [received]
PHST- 2012/02/17 00:00 [accepted]
PHST- 2012/01/10 00:00 [revised]
PHST- 2012/03/07 06:00 [entrez]
PHST- 2012/03/07 06:00 [pubmed]
PHST- 2013/07/03 06:00 [medline]
PHST- 2013/12/01 00:00 [pmc-release]
AID - 2213 [pii]
AID - 10.1007/s00586-012-2213-3 [doi]
PST - ppublish
SO  - Eur Spine J. 2012 Dec;21(12):2580-7. doi: 10.1007/s00586-012-2213-3. Epub 2012 
      Mar 6.