UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients
Title of the study (Brief title)	Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and feasibility of G-CSF tehrapy for acute complete spinal cord injury
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	ASIA motor score alteration 3 months after G-CSF aadministration
Key secondary outcomes	Change in AIS adverse events

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	G-CSF
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	acute spinal cord injury with complete paralysis patients who agree with the participation to the present trial
Key exclusion criteria	1. Allergy for G-CSF 2. Hematologic malignancy 3. Past history of any kind of malignancy within 5 years 4. Severe co-morbidity 5. Thorombosis 6. Splenomegaly 7. Consciousness disorder 8. Pregnancy 9. Neurological disorder which can affect neurological evaluation in the present trial
Target sample size	10

Research contact person
Name of lead principal investigator	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
Email	masaokod@gmail.com

Public contact
Name of contact person	Yukiko Matsumoto
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	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization	Other
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	千葉大学医学部附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 30 Day
Anticipated trial start date	2014 Year 05 Month 14 Day
Last follow-up date	2015 Year 03 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 05 Month 14 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016259