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Completed

NCT Number: NCT00901381

Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke

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

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Institute of the Brain

Yekaterinburg, 620026, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgrastim

Drug

10 µg/kg subcutaneously once daily x 5 days

Other names: Leukostim

Primary outcomes

  1. Dependence assessed by the modified Rankin scale

    Time frame: 180 day

Secondary outcomes

  1. Impairment assessed by the Medical Research Consul scale and National Institutes of Health Stroke Scale

    Time frame: 180 day

  2. Disability assessed by the Barthel Index and Glasgow Outcome Scale

    Time frame: 180 day

  3. Infarct size assessed by the magneto-resonance imaging

    Time frame: 180 day

  4. Safety was assessed as mortality, incidence of hemorrhagic transformation and serious adverse events

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Clinical Institute of the Brain, Russia

Other

Collaborators

  • City Hospital No 40, Saint Petersburg, Russia
  • Institute of Medical Cells Technologies

Registry information

Official study title

Open Prospective Randomized Controlled Trial of Efficacy and Safety of Granulocyte-colony Stimulating Factor Leukostim for Acute Ischemic Stroke.

Acronym: STEMTHER

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 13, 2009
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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