Angiogenesis augmentation therapy for indirect revascularization of moyamoya disease using G-CSF

JRCT ID: jRCTs071220048

Registered date:29/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Moyamoya disease
• Date of first enrollment: 20/10/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): G-CSF(75 micrograms/body) is applied intraoperatively to the indirect revascularization site, and G-CSF (75 micrograms/body) is given intravenously once daily for 2 days.

Outcome(s)

• Primary Outcome: adverse reaction within one month of G-CSF use
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Both

Include criteria

1.Moyamoya disease requiring direct/indirect revascularization.
2.Age:20-60 years old.
3.Obtain informed consent by the document.

Exclude criteria

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

Related Information

• Primary Sponsor: Morioka Motohiro