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The Effect of Granulocyte colony-stimulating factor (GCSF) Treatment for Improvement of Sensory, Motor and Sphincter Function in Patients with Spinal cord Injury

Effectiveness Study Comparing Granulocyte colony-stimulating factor (GCSF) with Placebo for Improvement of Sensory, Motor and Sphincter Function in Patients with Spinal cord Injury

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201108297441N1
Enrollment
60
Registered
2012-06-05
Start date
2011-11-02
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

traumatic spinal cord injury. Accidents

Interventions

Intervention 1: in the intervention group subcutaneous administration of 300 mcg GCSF will be performed for 5 days. Intervention 2: in the control group subcutaneous administration of placebo (normal
Treatment - Drugs
Placebo
in the intervention group subcutaneous administration of 300 mcg GCSF will be performed for 5 days
in the control group subcutaneous administration of placebo (normal saline) will be performed for 5 days

Sponsors

Brain and Spinal Injury Research Center, Tehran university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1.Patients must be able to give voluntary consent; 2-Age between 20 to 40 years old; 3-Time between injury and enrollment greater than 1 year; 4-No evidence of cord compression, disc herniation, cord atrophy and angulation deformity on the performed MRI; 5-no evidence of lower motor neuron injury; 6-no evidence of ossification; 7-optimized SCIM questionnaire score; 8-not using indwelling catheterization; 9-no evidence of any other systemic or psychological disorder; 10-no evidence of bedsore; 11-normal Complete Blood Count; 12- evidence of incomplete spinal cord injury according to the American Spinal Injury Association Impairment Scale. Exclusion criteria: 1-evidence of drug side effects; 2-past history of hematologic disorders in patients or patients’ first degree relatives.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sensory level score, motor score. Timepoint: before the intervention, 1st, 3rd, 6th and 12th months of study. Method of measurement: according to American Spinal Injury Association (ASIA) impairment scale.

Secondary

MeasureTime frame
Independent life ability. Timepoint: before the intervention, 1st, 3rd, 6th and 12th months of study. Method of measurement: Spinal Cord Independence Measure III.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hooshang Saberi

Tehran University of Medical Sciences

saberih@sina.tums.ac.ir , hgsaberi@yahoo.com+98 21 6658 1560

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 24, 2026