Document Detail


Neuroprotective therapy using granulocyte colony-stimulating factor for patients with worsening symptoms of compression myelopathy, Part 1: a phase I and IIa clinical trial.
MedLine Citation:
PMID:  21935680     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Based on the neuroprotective effects of granulocyte colony-stimulating factor (G-CSF) on experimental spinal cord injury, we initiated a clinical trial that evaluated the safety and efficacy of neuroprotective therapy using G-CSF for patients with worsening symptoms of compression myelopathy.
METHODS: We obtained informed consent from 15 patients, in whom the Japanese Orthopaedic Association (JOA) score for cervical myelopathy decreased two points or more during a recent 1-month period. G-CSF (5 or 10 μg/kg/day) was intravenously administered for five consecutive days. We evaluated motor and sensory functions of the patients and the presence of adverse events related to G-CSF therapy.
RESULTS: G-CSF administration suppressed the progression of myelopathy in all 15 patients. Neurological improvements in motor and sensory functions were obtained in all patients after the administration, although the degree of improvement differed among the patients. Nine patients in the 10-μg group (n=10) underwent surgical treatment at 1 month or later after G-CSF administration. In the 10-μg group, the mean JOA recovery rates 1 and 6 months after administration were 49.9±15.1 and 59.1±16.3%, respectively. On the day following the start of G-CSF therapy, the white blood cell count increased to more than 22,700 cells/mm3. It varied from 12,000 to 50,000 and returned to preadministration levels 3 days after completing G-CSF treatment. No serious adverse events occurred during or after treatment.
CONCLUSION: The results indicate that G-CSF administration at 10 μg/kg/day is safe for patients with worsening symptoms of compression myelopathy and may be effective for their neurological improvement.
Authors:
Tsuyoshi Sakuma; Masashi Yamazaki; Akihiko Okawa; Hiroshi Takahashi; Kei Kato; Mitsuhiro Hashimoto; Koichi Hayashi; Takeo Furuya; Takayuki Fujiyoshi; Junko Kawabe; Chikato Mannoji; Ryo Kadota; Masayuki Hashimoto; Kazuhisa Takahashi; Masao Koda
Publication Detail:
Type:  Case Reports; Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't     Date:  2011-09-21
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 Mar 
Date Detail:
Created Date:  2012-03-08     Completed Date:  2012-11-19     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  9301980     Medline TA:  Eur Spine J     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  482-9     Citation Subset:  IM    
Affiliation:
Spine Section, Department of Orthopaedic Surgery, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8677, Japan.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Disease Progression
Female
Granulocyte Colony-Stimulating Factor / administration & dosage*
Humans
Injections, Intravenous / methods
Male
Middle Aged
Neuroprotective Agents / administration & dosage*
Paresthesia / drug therapy,  etiology,  physiopathology
Quadriplegia / drug therapy,  etiology,  physiopathology
Recovery of Function / drug effects,  physiology
Spinal Cord / drug effects*,  physiology
Spinal Cord Compression / drug therapy*,  etiology,  physiopathology*
Spondylosis / complications,  physiopathology*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Neuroprotective Agents; 143011-72-7/Granulocyte Colony-Stimulating Factor
Comments/Corrections

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