UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001079
Receipt number 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 15:26:16

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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 or person

Institute

Chiba University Hospital

Institute

Department

Personal name



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

Value
https://center6.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