Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease

Investigators will evaluate the safety of a 48 week regimen of Leukine administered as a weight-based dose at 3 ug/kg/ day for 5 days followed by a 2-day holiday. This 48 week long study will extend the prior biomarker evaluations observed in a previous study. Clinical signs and symptoms will be measured by personal well-being, physical, and neurological examinations (UPDRS Parts I, II, III, and IV assessments) and blood tests (CBC with differential, total T cell count, and a comprehensive metabolic sera panel). Leukapheresis will be performed to collect large numbers of immune cells for biomarker testing and immune phenotyping. Additionally, the investigators will determine whether immune deficits of PD are consistent during baseline data collection, and the potential Leukine-induced motor control and mobility improvements will be determined by UPDRS part I, II, III, and IV scores off treatment and on treatment.

Inclusion Criteria:Onset of bradykinesia and 1 or both of the following: rest tremor and/or rigidityAsymmetric onset of clinical signsProgressive motor symptomsAge at onset 35-85 yearsDuration of PD symptoms of at least 3 yearsFemale 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; orIf 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 scaleExclusion 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 failureNeuroleptic treatment at time of onset of parkinsonismActive treatment with a neuroleptic at time of study entryHistory of repeated strokes with stepwise progression of parkinsonismHistory of repeated head injuryHistory of definite encephalitisMore than one blood relative diagnosed with PDProminent gait imbalance early in the course (< 5 years)Mini-mental state examination score <26Hematological malignancy or coagulopathyAbnormal 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 participantsSerious medical illness or co-morbidity that may interfere with participation in the studyBrain surgery for parkinsonism (DBS, cell implantation, gene therapy)History of an autoimmune disorder or systemic inflammatory disorder deemed significant by physicianImmunostimulatory or immunosuppressive treatment (including amphet-amines or systemic corticosteroids) within 90 daysExclusively unilateral parkinsonism for longer than 3 yearsKnown hypersensitivity to GM-CSF, yeast-derived productsCurrent lithium treatmentIndividuals with current diagnoses of alcohol or substance abuse/dependenceAnyone who is not appropriate for participation in this research protocol as deemed by the principal or co-investigatorAnyone who has previously been treated with GM-CSF as an immunomodulatory therapyAnyone with poor venous accessAnyone 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.