The Effect of GCSF in the Treatment of ALS Patients

The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01825551

Enrollment

Registered

2013-04-05

Start date

2012-11-30

Completion date

2013-11-30

Last updated

2013-11-13

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

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, Granulocyte Colony Stimulating Factor

Brief summary

The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) patients.

Interventions

DRUGGranulocyte Colony Stimulating Factor

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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 revised ALS functional rating scale (ALSFRS-r)

Exclusion criteria

* familial ALS * pregnancy or lactation * myeloproliferative or hematologic disorders * active immunological disease * liver or renal or heart disease * HIV positive * significant cognitive disorder * hypersensitivity to GCSF

Design outcomes

Primary

Measure	Time frame	Description
patient's function	one year	based on revised ALS Functional Rating scale (ALSFRS-r)

Secondary

Measure	Time frame	Description
mobilizing bone marrow stem cells	1 year	based on cluster of differentiation 34 (CD34) and white blood cell (WBC) counting
amplitude of compound muscle action potential in ulnar and peroneal nerve	1 year	based on compound muscle action potential (CMAP) measured in nerve conduction study
quality of life	1 year	based on Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ40)
muscle power	1 year	based on Muscle Manual Test (MMT)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026