Clinical trial NCT00901381: Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
Official title: Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Stem cells
Colony-stimulating factors
Filgrastim
Randomized controlled trial
Lead sponsor: Clinical Institute of the Brain, Russia
Sponsor class: OTHER
Collaborators: name: Institute of Medical Cells Technologies
name: City Hospital No 40, Saint Petersburg, Russia
First posted: 2009-05-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate treatment with Leukostim (Filgrastim; granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.

Detailed description: Stroke is one of the main reasons of mortality and morbidity all over the world. In economically developed countries stroke takes 2 or 3 place in the structure of morbidity and mortality. In animal models, it was shown that autological stem cells transplantation significantly increased perfusion of ischemic area and improved lost motor and sensor functions. Granulocyte-colony stimulating factor (G-CSF) was used in some clinical trials without following autological transplantation. However, there are no enough evidence-based proved results of G-GSF safety and effectiveness in acute ischemic stroke. In order to determine safety and efficiency of G-CSF administration together with conventional treatment and conventional intensive care protocol during acute ischemic stroke we organized this clinical trial.

Eligibility criteria: Inclusion Criteria:

* Age between 40 to 70 years old
* CT/MRI confirmed ischemic stroke in carotid area during 48 hours after the onset of clinical signs
* Level of conscious lower than 15 and higher than 8 points by the Glasgow Coma Scale
* Acute extremity paresis lower than 4 points by Medical Research Consul scale

Exclusion Criteria:

* Premorbid dependency (modified Rankin Scale \> 0)
* Intracerebral hemorrhage
* Transitory ischemic attack
* Patients with previous stroke
* Any disorders, that can affect interpretation of results (e.g. psychiatric or movement disorders)
* Hematological diseases
* Coagulopathy
* Malignancy
* Pregnancy and lactation
* Organ dysfunction that would preclude tests required for this study
* Known allergic reaction to G-CSF or a component of G-CSF
* Patients that have received a cytokine within the last 1 month or are currently receiving a cytokine treatment

Primary outcomes:
measure: Dependence assessed by the modified Rankin scale
timeFrame: 180 day
Secondary outcomes:
measure: Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale
timeFrame: 180 day
measure: Disability assessed by the Barthel Index and Glasgow Outcome Scale
timeFrame: 180 day
measure: Infarct size assessed by the magneto-resonance imaging
timeFrame: 180 day
measure: Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events
timeFrame: Duration of study
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Clinical Institute of the Brain
Study officials:
affiliation: Clinical Institute of the Brain, Russia
name: Andrey A Belkin, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: