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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001079
Receipt No. 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

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Basic information
Public title Granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
Acronym G-CSF therapy for spinal cord injury
Scientific Title Granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury
Scientific Title:Acronym G-CSF therapy for spinal cord injury
Region
Japan

Condition
Condition acute spinal cord injury
Classification by specialty
Orthopedics Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the safety of granulocyte colony-stimulating factor for acute spinal cord injury
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes To clarify the safety of granulocyte colony-stimulating factor for acute spinal cord injury
Key secondary outcomes degree of sensory or motor paralysis, functional impairment coused by the paralysis, MRI imaging of injured spinal cord

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of granulocyte colony-stimulating factor
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Yamazaki
Organization Chiba University Hospital
Division name Department of Orthopaedic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-226-2117
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University, Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address
TEL 043-226-2117
Homepage URL
Email

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 15 Day
Last modified on
2011 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.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


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