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The effect of Granolocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients referred to Tehran Imam Khomeini and Shariati hospital centers in 2012.

Protocol summary

Summary
The aim of study is to evaluate the effect off Granolocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients. program: multicenter, double blind, controlled, randomized clinical trial. sample: patients with ALS referred to Tehran Imam Khomeini and Shariati hospital centers. major inclusion criteria: age between 18 and 85, definite or probable ALS, maximum 2 years from initiation of symptoms to study entry, mild to moderate disability according to ALSFRS-r. major exclusion criteria: pregnancy or lactation, neoplasia, mieloproliferative or hematologic disorders, active immunological disease, splenomegaly, liver or renal or heart disease, HIV positive, significant cognitive disorder, hypersensitivity to GCSF sample size: 40 patients interventions: Granolocyte Colony Stimulating Factor 10 microgram/ kg/ day or normal saline 0.01 ml/kg/day subcutaneously time of intervention: for 5 days Primary outcome measure: patient`s function according to ALSFRS-r criteria. Secondary outcome measure:changing in mobilizing factors of bone marrow stem cells including CD34 count,amplitude of compound muscle action potential in ulnar and proneal nerve, quality of life by ALSAQ-40 questioner, muscle power by Manual Muscle Test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207238509N2
Registration date: 2012-08-17, 1391/05/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Nasibeh Amirzargar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 0582
Email address
n-amirzargar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iranian Neurology Research Center of Tehran University of Medical SciencesImmunology Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-11-06, 1392/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Granolocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients referred to Tehran Imam Khomeini and Shariati hospital centers in 2012.
Public title
The effect of Granolocyte Colony Stimulating Factor in treatment of Amyotrophic Lateral Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age between 18 and 85, definite or probable ALS according to revised El Escorial criteria, maximum 2 years from initiation of symptoms to study entry, mild to moderate disability according to ALSFRS-r , permanent use of rilosole for at least 30 days. exclusion criteria: familial ALS, pregnancy or lactation, neoplasia, mieloproliferative or hematologic disorders, active immunological disease, splenomegaly, liver or renal or heart disease, HIV positive, FVC below 50%, significant cognitive disorder, hypersensitivity to GCSF
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences- research center
Street address
number 1- Ghods Avenue- Keshavarz Boulevard- central building of Tehran University of Medical Sciences
City
tehran
Postal code
Approval date
2012-07-18, 1391/04/28
Ethics committee reference number
91-01-54-17265-58480

2

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences- research assistant
Street address
number 16, Poursina Street, 16th Azar Avenue, Keshavarz Boulevard
City
tehran
Postal code
Approval date
2012-08-06, 1391/05/16
Ethics committee reference number
91-د-130-971

Health conditions studied

1

Description of health condition studied
amyotrophic lateral sclerosis
ICD-10 code
VI
ICD-10 code description
Diseases of the nervous system

Primary outcomes

1

Description
patient`s function
Timepoint
before intervention and 3 months after intervention
Method of measurement
ALS functional rating scale questioner

Secondary outcomes

1

Description
mobilizing bone marrow stem cells
Timepoint
before intervention and day 3 and 6 after initiation of intervention
Method of measurement
CD34 count

2

Description
amplitude of compound muscle action potential in ulnar and proneal nerve
Timepoint
before intervention and3 months after initiation of intervention
Method of measurement
EMG-NCV

3

Description
quality of life
Timepoint
before intervention and 3 months after intervention
Method of measurement
ALSAQ-40 questioner

4

Description
muscle power
Timepoint
before intervention and 3 months after intervention
Method of measurement
Manual muscle test

Intervention groups

1

Description
normal saline 0.01 ml/kg/day for 5 days subcutaneously
Category
Placebo

2

Description
Granolocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital, Iranian neurology research center
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Street address
Iranian neurology research center, Imam Khomeini hospital, Gharib Street, Keshavarz Boulevard
City
tehran

2

Recruitment center
Name of recruitment center
department of neurology in Shariati hospital
Full name of responsible person
dr. Shahriyar Nafisi
Street address
department of neurology, Shariati hospital, North Karegar Avenue
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian neurology research center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Street address
Iranian neurology research center, Imam Khomeini hospital
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian neurology research center of Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
immunology research center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Amirzargar
Street address
immunology research center in Tehran university of medical sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
immunology research center of Tehran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian neurology research center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Position
manager of neurology department of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Iranian neurology research center, Imam Khomeini hospital
City
tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
harirchm@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian neurology research center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Position
neurologyst
Other areas of specialty/work
Street address
Iranian neurology research center, imam khomeini hospital
City
tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
harirchm@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian neurology research center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Harirchian
Position
neurologyst
Other areas of specialty/work
Street address
Iranian neurology research center, imam khomeini hospital
City
tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
harirchm@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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