Unique ID issued by UMIN | UMIN000001079 |
---|---|
Receipt number | R000001272 |
Scientific Title | Granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury |
Date of disclosure of the study information | 2008/04/01 |
Last modified on | 2011/12/11 15:26:16 |
Granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
G-CSF therapy for spinal cord injury
Granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
G-CSF therapy for spinal cord injury
Japan |
acute spinal cord injury
Orthopedics | Emergency medicine |
Others
NO
To clarify the safety of granulocyte colony-stimulating factor for acute spinal cord injury
Safety
Exploratory
Phase I,II
To clarify the safety of granulocyte colony-stimulating factor for acute spinal cord injury
degree of sensory or motor paralysis, functional impairment coused by the paralysis, MRI imaging of injured spinal cord
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
administration of granulocyte colony-stimulating factor
16 | years-old | <= |
70 | years-old | >= |
Male and Female
Acute spinal cord injury patients (within 8 hours after the injury).
The patient who does not conflict with exclusion criteria.
The patient who has sufficient understanding in participation of an exam, and the patient by whom the document consent by the free intention of the person himself/herself was got.
Allergy for G-CSF.
A patient with the past of a hematopoietic system malignant disease,
any malignant disease within 5 years, angina, myocardial infarction, thrombosis, splenpmegary, consciousness disorder or pregnancy.
A patient with the past which has concurred with the diseases of the nervous system which can have on neurological-symptoms evaluations, such as cerebral infarction.
In addition, the patient whom the examination responsibility (assignment) doctor judged to be unsuitable as a subject.
10
1st name | |
Middle name | |
Last name | Masashi Yamazaki |
Chiba University Hospital
Department of Orthopaedic Surgery
1-8-1 Inohana, Chuo-ku, Chiba, Japan
043-226-2117
1st name | |
Middle name | |
Last name |
Chiba University, Graduate School of Medicine
Department of Orthopaedic Surgery
043-226-2117
Chiba University Hospital
None
Self funding
NO
2008 | Year | 04 | Month | 01 | Day |
Partially published
There was no obvious adverse effects by G-CSF administration for acute spinal cord injury patients. All the patients showed motor/sensory recovery after G-CSF administration.
Completed
2008 | Year | 03 | Month | 03 | Day |
2008 | Year | 04 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2008 | Year | 03 | Month | 15 | Day |
2011 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001272
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |