Clinical trial NCT01227681: Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Official title: A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Motor Performance of Unified Parkinson's Disease Rating Scale
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Buddhist Tzu Chi General Hospital, Hualien
name: Shin Yuan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: