UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024521 |
|---|---|
| Receipt number | R000028225 |
| Scientific Title | Prospective, non-randomized, non-blinded clinical trial of granulocyte colony-stimulating factor for acute spinal cord injury |
| Date of disclosure of the study information | 2016/10/21 |
| Last modified on | 2016/10/21 20:20:46 |
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Basic information
Public title
Prospective, non-randomized, non-blinded clinical trial of granulocyte colony-stimulating factor for acute spinal cord injury
Acronym
Clinical trial of G-CSF for spinal cord injury
Scientific Title
Prospective, non-randomized, non-blinded clinical trial of granulocyte colony-stimulating factor for acute spinal cord injury
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Takahashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
043-226-2961
chibaseikei8f@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Koda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Orthopedic Surgery
Zip code
Address
1-8-1 Inohana, Chuo-Ku, Chiba
TEL
043-226-2961
Homepage URL
chibaseikei8f@yahoo.co.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2012 | Year | 10 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028225
