Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease

Inclusion Criteria: Onset of bradykinesia and 1 or both of the following: rest tremor and/or rigidity Asymmetric onset of clinical signs Progressive motor symptoms Age at onset 35-85 years Duration of PD symptoms of at least 3 years Female subjects must be either: Not pregnant, not breastfeeding, and not planning on becoming pregnant during the study; Not of childbearing potential, defined as one who has been postmenopausal for at least 1 year and with follicle stimulating hormone (FSH) levels in the laboratory defined postmenopausal range, or has been surgically sterilized, or has had a hysterectomy at least 3 months prior to the start of this trial; or If of childbearing potential, must agree to use an effective method of avoiding pregnancy to the end of the trial and must have a negative serum beta-human chorionic gonadotropin (β-HCG) test. Effective methods of avoiding pregnancy are contraceptive methods used consistently and correctly (including implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap), abstinence, or a sterile sexual partner. Must be stage 4 or less according to the Hoehn and Yahr scale Exclusion Criteria: Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure Neuroleptic treatment at time of onset of parkinsonism Active treatment with a neuroleptic at time of study entry History of repeated strokes with stepwise progression of parkinsonism History of repeated head injury History of definite encephalitis More than one blood relative diagnosed with PD Prominent gait imbalance early in the course (< 5 years) Mini-mental state examination score <26 Hematological malignancy or coagulopathy Abnormal blood analyses: hematocrit <30; WBC>11.5; clinically significant laboratory data (e.g. alanine aminotransferase [ALT] or aspartate aminotransferase [AST] 3x the upper limit of normal [ULN]), or any abnormal laboratory value that could interfere with the assessment of safety in the judgment of the investigator; significant abnormalities on the clinical examination, vital signs, and clinical chemistry or hematology results (excluding findings of Parkinson's disease), that may interfere with the study or present a safety risk for the subject as judged by the clinical investigator charged in the care of study participants Serious medical illness or co-morbidity that may interfere with participation in the study Brain surgery for parkinsonism (DBS, cell implantation, gene therapy) History of an autoimmune disorder or systemic inflammatory disorder deemed significant by physician Immunostimulatory or immunosuppressive treatment (including amphet-amines or systemic corticosteroids) within 90 days Exclusively unilateral parkinsonism for longer than 3 years Known hypersensitivity to GM-CSF, yeast-derived products Current lithium treatment Individuals with current diagnoses of alcohol or substance abuse/dependence Anyone who is not appropriate for participation in this research protocol as deemed by the principal or co-investigator Anyone who has previously been treated with GM-CSF as an immunomodulatory therapy Anyone with poor venous access Anyone who has any illnesses or events that would cause a neurological abnormality, apart from Parkinson's disease. Subjects with allergies or sensitivities to yeast products. Subjects that have received a flu shot within the past 3 weeks.