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G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)

G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2) - G-CSF employing neuroprotection study for ischemic stroke -Phase 2 clinical trial-(GENESIS-2)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006607
Enrollment
100
Registered
2011-12-01
Start date
2011-12-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

acute cerebral infarction

Interventions

G-CSF(75 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset. G-CSF(150 micrograms/body) is intravenously given twice a day for 5 days at 24 hours after onset. Sal

Sponsors

Tokai University, School of Medicine, Division of Neurology, Department of Internal Medicine.
Lead Sponsor
Okayama University, Department of Neurology, Graduate School of Medicine, Dentistry, and Pharmacological Sciences. Fujita Health University, Department of Neurology.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Acute ischemic stroke at 24 hours after onset. 2.Patients with occlusion of middle cerebral artery territory, at least including its cortical branch, on MRI. 3.Atherothrombotic or cardioembolic strokes. 4.NIHSS:4-22 points 5.Age:45-85 years old. 6.Obtain informed consent by the document.

Exclusion criteria

Exclusion criteria: 1.Splenomegaly or splenic lesions on echo. 2.Leukocytosis more than 15000/mm3 3.Past history of G-CSF treatment. 4.Plan for percutaneous angiography or bypass operations. 5.Difficult to perform MRI. 6.Past histries of symptomatic intracranial hemorrhage, bleeding tendency or coagulating disorders. 7.Hyper reactivity to G-CSF. 8.Congestive heart failure or uncontrollable angina. 9.Thrombocytopenia(less than 140000/mm3) 10.Liver dysfunction(AST(GOT),ALT(GPT) more than 100 IU/L) 11.Renal dysfunction (creatinine 1.5mg/dl and more) 12.Difficult to continue this trial due to social problems, etc. 13.Join other clinical trials. 14.Inappropriate to enroll in this trial by the judgment of the doctor.

Design outcomes

Primary

MeasureTime frame
Safety(leukocyte count, size of spleen) Clinical outcome at 3 months after the onset(mRS, BI)—

Secondary

MeasureTime frame
Size of infarct on MRI, biomarkers such as inflammation cytokines, etc.—

Countries

Japan

Contacts

Public ContactShunya Takizawa

Tokai University, School of Medicine. Division of Neurology, Department of Internal Medicine.

shun@is.icc.u-tokasi.ac.jp0463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026