The effect of Granolocyte Colony Stimulating Factor in treatment of Amyotrophic Lateral Sclerosis

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201207238509N2

Enrollment

Registered

2012-08-17

Start date

2012-08-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amyotrophic lateral sclerosis. Diseases of the nervous system

Interventions

Intervention 1: normal saline 0.01 ml/kg/day for 5 days subcutaneously. Intervention 2: Granolocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously.

Placebo

Treatment - Drugs

normal saline 0.01 ml/kg/day for 5 days subcutaneously

Granolocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Patient`s function. Timepoint: before intervention and 3 months after intervention. Method of measurement: ALS functional rating scale questioner.	—

Secondary

Measure	Time frame
Mobilizing bone marrow stem cells. Timepoint: before intervention and day 3 and 6 after initiation of intervention. Method of measurement: CD34 count.;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.;Quality of life. Timepoint: before intervention and 3 months after intervention. Method of measurement: ALSAQ-40 questioner.;Muscle power. Timepoint: before intervention and 3 months after intervention. Method of measurement: Manual muscle test.	—

Measure

Time frame

Mobilizing bone marrow stem cells. Timepoint: before intervention and day 3 and 6 after initiation of intervention. Method of measurement: CD34 count.;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.;Quality of life. Timepoint: before intervention and 3 months after intervention. Method of measurement: ALSAQ-40 questioner.;Muscle power. Timepoint: before intervention and 3 months after intervention. Method of measurement: Manual muscle test.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Hossein Harirchian

Iranian neurology research center of Tehran University of Medical Sciences

harirchm@sina.tums.ac.ir+98 21 6119 2424

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026