UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013955 |
|---|---|
| Receipt number | R000016259 |
| Scientific Title | Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients |
| Date of disclosure of the study information | 2014/05/14 |
| Last modified on | 2019/03/07 14:42:38 |
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Basic information
Public title
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients
Acronym
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients
Scientific Title
Granulocyte colony-stimulating factor-mediated neuroprotective therapy for acute complete spinal cord injury patients
Scientific Title:Acronym
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
| 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
masaokod@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Matsumoto |
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
Chiba University Graduate School of Medicine
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2013 | Year | 08 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016259
