UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective, non-randomized, non-blinded clinical trial of granulocyte colony-stimulating factor for acute spinal cord injury
Title of the study (Brief title)	Clinical trial of G-CSF for spinal cord injury
Region	Japan

Condition
Condition	spinal cord injury
Classification by specialty	Orthopedics Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present trial is to elucidate the efficacy of granulocyte colony-stimulating factor for acute spinal cord inury.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Change of ASIA motor score between baseline and three months after G-CSF administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Granulocyte colony-stimulating factor 10 microgam/kg/day, intravenous infusion for 5 days
Interventions/Control_2	conventional treatment
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	acute spinal cord injury Neurological level of injury between C4 and C7
Key exclusion criteria	1. allergy for G-CSF 2. Hematological malignancy 3. malignancy within 5 years 4. acute myocardial infarction 5. thorombosis 6. splenomegaly 7. consciousness disorder 8. pregnancy 9. neurological disorder which affects neurological evaluation
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuhisa Takahashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedic Surgery
Address	1-8-1 Inohana, Chuo-Ku, Chiba
TEL	043-226-2961
Email	chibaseikei8f@yahoo.co.jp

Public contact
Name of contact person	Masao Koda
Organization	Chiba University Graduate School of Medicine
Division name	Department of Orthopedic Surgery
Address	1-8-1 Inohana, Chuo-Ku, Chiba
TEL	043-226-2961
Homepage URL
Email	chibaseikei8f@yahoo.co.jp

Sponsor
Institute	Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2016 Year 10 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 21 Day
Anticipated trial start date	2012 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 21 Day
Last modified on	2016 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028225