Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease

Buddhist Tzu Chi General Hospital

Status and phase: Terminated; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: G-CSF; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01227681

TCSP-01

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease

Full description

Parkinson's disease (PD) is the second most common neurodegenerative disease and the severity of PD still progress during the ensuing years. Currently, there is no promising medical or surgical treatment to abrogate the disease deterioration. Granulocyte colony-stimulating factor (G-CSF), one of hematopoietic growth factors, has been routinely used for hematologic disorders and stem cell harvest from normal subject. G-CSF also demonstrated neuroprotection for rodents PD model. We hypothesize G-CSF will exert the effectiveness of neuroprotection for PD patients.

Enrollment: 4 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hoehn & Yahr stage I~III
• Patients with idiopathic Parkinson's disease(PD), who meet the United Kingdom Parkinson's Disease Society Brain Bank diagnostic criteria, with a good response to levodopa
• The onset of PD symptoms must be occurred > = 40 years of age (to exclude YOPD), and the patient must have been diagnosed with idiopathic PD > =40 years of age
• Patients may have symptoms of wearing OFF and/or levodopa induced dyskinesia
• Patients must rate between Hoehn & Yahr stage I to III, when in an OFF medication state
• Patients must in their optimal medication treatment state, and will not changing their medications within 3 months before and after enrollment

Exclusion criteria

• Patients who are proved to be Young Onset Parkinson's Disease (YOPD) and/or genetically related (e.g. Parkin).
• Women of child-bearing potential, pregnant or lactating.
• Patients who are proved to have tumor growth and/or malignancy.
• Patients with a past (within one year) or present history of psychotic symptoms requiring anti- psychotic treatment.
• Patients with active symptoms of major depression with suicidal ideation or suicide attempt.
• Patients with previous brain surgery (including pallidotomy and deep brain stimulation).
• Patients with significant cognitive impairment ( Mini-Mental State Examination, MMSE < 24).
• Patients who do not sign the inform consent,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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4 participants in 3 patient groups, including a placebo group

high dose G-CSF

Experimental group

Description:

high dose group: 3.3ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)

Treatment:

Drug: G-CSF

low dose G-CSF

Active Comparator group

Description:

low dose group: 1.65ug/kg/day for consecutive 5 days of each 60 day cycle (6 cycles)

Treatment:

Drug: G-CSF

placebo

Placebo Comparator group

Description:

Sodium Chloride (NaCl) 0.9 %

Treatment:

Drug: Placebo