Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease
This trial is active, not recruiting.
|Treatment||granulocyte colony stimulating factor|
|Sponsor||Buddhist Tzu Chi General Hospital|
|Start date||June 2010|
|End date||December 2013|
|Trial size||36 participants|
|Trial identifier||NCT01227681, TCSP-01|
The purpose of this study is to evaluate the effectiveness of neuroprotection from granulocyte colony-stimulating factor on Parkinson disease
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
motor performance on Unified Parkinson's Disease Rating Scale
time frame: 2 years
Male or female participants from 40 years up to 65 years old.
- 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
- 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,
|Official title||A Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's Disease|
|Principal investigator||Shin Yuan Chen, MD|
|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.|
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