<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03790670</url>
  </required_header>
  <id_info>
    <org_study_id>0839-18-FB</org_study_id>
    <nct_id>NCT03790670</nct_id>
  </id_info>
  <brief_title>Biomarker Assessments of Leukine During Treatment of Parkinson's Disease</brief_title>
  <official_title>Safety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      First, the investigators will determine the safety of a 36 month regimen of Leukine&#xD;
      administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day&#xD;
      holiday (weekend). This 36 month (n=10) pilot study will extend the prior 2 month observation&#xD;
      tests towards the goal of assessing the safety of Leukine for treatment of Parkinson's&#xD;
      disease (PD). Clinical signs and symptoms will be measured by personal well-being, physical,&#xD;
      and neurological examinations (UPDRS Parts I, II, III, and IV assessments) and blood tests&#xD;
      (CBC with differential, total T cell count, and a comprehensive metabolic sera panel).&#xD;
      Second, we will assess regimen tolerability administered in a dose reduction, from 6&#xD;
      µg/kg/day without interruption, to 3 µg/kg/day with 2 day drug holidays. The investigators&#xD;
      will examine over a time of 36 months, effects of treatment on defined adaptive immune&#xD;
      deficits in PD as measured by analysis of peripheral blood mononuclear cells collected&#xD;
      before, during, and after cessation of Leukine administration. Individual T cell parameters&#xD;
      will be assessed and will include links between T cell function and subset analyses and&#xD;
      clinical neurological signs and symptoms. In addition, the functional stability of the immune&#xD;
      deficits will be assess in PD by examining T cell subsets in PD patients in this study&#xD;
      against prior results. The investigators will also determine whether the immune deficits of&#xD;
      PD are consistent during baseline data collection, and the potential Leukine-induced motor&#xD;
      control and mobility improvements will be determined by UPDRS part I, II, III, and IV scores&#xD;
      off treatment and on treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives: There are three study goals. First, the investigators will determine the&#xD;
      safety of a 36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day&#xD;
      for 5 days (week), followed by a 2-day holiday (weekend). This 36 month (n=10) pilot study&#xD;
      will extend the prior 2 month observation tests towards the goal of assessing the safety of&#xD;
      Leukine for treatment of Parkinson's disease (PD). Clinical signs and symptoms will be&#xD;
      measured by personal well-being, physical, and neurological examinations (UPDRS Parts I, II,&#xD;
      III, and IV assessments) and blood tests (CBC with differential, total T cell count, and a&#xD;
      comprehensive metabolic sera panel). Second, the investigators will assess regimen&#xD;
      tolerability administered in a dose reduction, from 6 µg/kg/day without interruption, to 3&#xD;
      µg/kg/day with 2 day drug holidays. The lowered dose was chosen based on known tolerability&#xD;
      and parallel-linked immune reconstitution seen in cancer-associated disease treatments. Due&#xD;
      to fragility of the patient population and prior recorded adverse events the proposed dose&#xD;
      reductions are justified.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      Over a course of 36 months, the effects of treatment on defined adaptive immune deficits in&#xD;
      PD as measured by analysis of peripheral blood mononuclear cells collected before, during,&#xD;
      and after cessation of Leukine administration will be examined. Individual T cell parameters&#xD;
      that include links between T cell function and subset analyses and clinical neurological&#xD;
      signs and symptoms will be examined. These immune parameters will be serially examined as&#xD;
      they may contribute to the immune deficits in PD. Thus, timed analyses of changes in T cell&#xD;
      phenotypes and/or function will be completed. In addition, the investigators will assess the&#xD;
      functional stability of the immune deficits in PD and will determine whether the immune&#xD;
      deficits of PD are consistent during baseline data collection. The potential Leukine-induced&#xD;
      motor control and mobility improvements will be determined by assessing UPDRS part I, II,&#xD;
      III, and IV scores off treatment and on treatment. Specifically, over the course of this&#xD;
      six-month treatment study, various biomarkers will be assessed including: T cell markers of&#xD;
      immune activation, DNA methylation status, and B cell and bone marrow progenitor cell&#xD;
      markers. We hope to uncover the time course of Treg induction, as well as link the&#xD;
      pharmacokinetics of Leukine treatment (not previously recorded) to changes in specific&#xD;
      biomarkers. Additionally, changes in the humoral response following extended Leukine&#xD;
      treatment will be assessed by measuring the presence of antibodies against Leukine and&#xD;
      alterations in B cell frequencies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Associated Adverse Events</measure>
    <time_frame>monthly during the course of treatment, up to 36 months, followed by 1 month drug cessation</time_frame>
    <description>The safety of Leukine administration in PD will be examined by documenting abnormal results from CBC with differential, total T cell count, or comprehensive metabolic panel analyses; abnormal physical and or neurological exam findings; abnormal levels of antibodies to GM-CSF; clinically increasing Unified Parkinson's disease Rating Scale (UPDRS) part I, II, III, and IV scores as determined by the examining physician; and other adverse events. These safety assessments will be made every four weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of Immune Cell Phenotype</measure>
    <time_frame>36 months of treatment, followed by 1 month drug cessation</time_frame>
    <description>Measurements will include change in CD45RO+ or FAS+ frequencies in CD4+ T cells; change in CD31+ frequencies in CD4+ T cells, Teff or Treg subsets; change in ItgB7+ frequencies in CD4+ T cells or the Teff subset; change in ItgB4B7+ frequencies in CD4+ T cells or the Treg subset; change in CD27+ frequencies in CD4+ T cells, Teff or Treg subsets, change in CCR7+ frequencies in CD4+ T cells, Teff or Treg subsets; change in FoxP3+ frequencies in CD4+ T cells, Teff or Treg subsets; change in CD34, CD117, or CD135 levels; change in DNA methylation status. The measurements will be combined to determine overall changes in immune cell frequency and T cell subset phenotype both on and off treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of Immune Cell Number</measure>
    <time_frame>36 months of treatment, followed by 1 month drug cessation</time_frame>
    <description>Measurements will include changes in levels of lymphocytes or CD4+ T cells, as well as T cell, B cell, and bone marrow progenitor subsets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of Immune Cell Function</measure>
    <time_frame>36 months of treatment, followed by 1 month drug cessation</time_frame>
    <description>Measurements will include changes in T cell function via proliferation and suppression assays and/or changes in B cell function via antibody production assessments.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Leukine Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day holiday (weekend)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sargramostim</intervention_name>
    <description>Recombinant human GM-CSF produced by recombinant DNA technology using a yeast (S. cerevisiae) expression system</description>
    <arm_group_label>Leukine Treatment</arm_group_label>
    <other_name>Leukine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Onset of bradykinesia and 1 or both of the following: rest tremor and/or rigidity&#xD;
&#xD;
             2. Asymmetric onset of clinical signs&#xD;
&#xD;
             3. Progressive motor symptoms&#xD;
&#xD;
             4. Age at onset 35-85 years&#xD;
&#xD;
             5. Duration of PD symptoms of at least 3 years&#xD;
&#xD;
             6. Female subjects must be either:&#xD;
&#xD;
               1. Not pregnant, not breastfeeding, and not planning on becoming pregnant during the&#xD;
                  study;&#xD;
&#xD;
               2. Not of childbearing potential, defined as one who has been postmenopausal for at&#xD;
                  least 1 year and with follicle stimulating hormone (FSH) levels in the laboratory&#xD;
                  defined postmenopausal range, or has been surgically sterilized, or has had a&#xD;
                  hysterectomy at least 3 months prior to the start of this trial; or&#xD;
&#xD;
               3. If of childbearing potential, must agree to use an effective method of avoiding&#xD;
                  pregnancy to the end of the trial and must have a negative serum beta-human&#xD;
                  chorionic gonadotropin (β-HCG) test. Effective methods of avoiding pregnancy are&#xD;
                  contraceptive methods used consistently and correctly (including implantable&#xD;
                  contraceptives, injectable contraceptives, oral contraceptives, transdermal&#xD;
                  contraceptives, intrauterine devices, diaphragm with spermicide, male or female&#xD;
                  condoms with spermicide, or cervical cap), abstinence, or a sterile sexual&#xD;
                  partner.&#xD;
&#xD;
                  7. Must be stage 4 or less according to the Hoehn and Yahr scale&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  1. Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear&#xD;
             Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including&#xD;
             cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or&#xD;
             prominent autonomic failure&#xD;
&#xD;
             2. Neuroleptic treatment at time of onset of parkinsonism&#xD;
&#xD;
             3. Active treatment with a neuroleptic at time of study entry&#xD;
&#xD;
             4. History of repeated strokes with stepwise progression of parkinsonism&#xD;
&#xD;
             5. History of repeated head injury&#xD;
&#xD;
             6. History of definite encephalitis&#xD;
&#xD;
             7. More than one blood relative diagnosed with PD&#xD;
&#xD;
             8. Prominent gait imbalance early in the course (&lt; 5 years)&#xD;
&#xD;
             9. Mini-mental state examination score &lt;26&#xD;
&#xD;
             10. Hematological malignancy or coagulopathy&#xD;
&#xD;
             11. Abnormal blood analyses: hematocrit &lt;30; WBC&gt;11.5; clinically significant&#xD;
             laboratory data (e.g. alanine aminotransferase [ALT] or aspartate aminotransferase&#xD;
             [AST] 3x the upper limit of normal [ULN]), or any abnormal laboratory value that could&#xD;
             interfere with the assessment of safety in the judgment of the investigator;&#xD;
             significant abnormalities on the clinical examination, vital signs, and clinical&#xD;
             chemistry or hematology results (excluding findings of Parkinson's disease), that may&#xD;
             interfere with the study or present a safety risk for the subject as judged by the&#xD;
             clinical investigator charged in the care of study participants&#xD;
&#xD;
             12. Serious medical illness or co-morbidity that may interfere with participation in&#xD;
             the study&#xD;
&#xD;
             13. Brain surgery for parkinsonism (DBS, cell implantation, gene therapy)&#xD;
&#xD;
             14. History of an autoimmune disorder or systemic inflammatory disorder deemed&#xD;
             significant by physician&#xD;
&#xD;
             15. Immunostimulatory or immunosuppressive treatment (including amphet-amines or&#xD;
             systemic corticosteroids) within 90 days&#xD;
&#xD;
             16. Exclusively unilateral parkinsonism for longer than 3 years&#xD;
&#xD;
             17. Known hypersensitivity to GM-CSF, yeast-derived products&#xD;
&#xD;
             18. Current lithium treatment&#xD;
&#xD;
             19. Individuals with current diagnoses of alcohol or substance abuse/dependence&#xD;
&#xD;
             20. Anyone who is not appropriate for participation in this research protocol as&#xD;
             deemed by the principal or co-investigator&#xD;
&#xD;
             21. Anyone who has previously been treated with GM-CSF as an immunomodulatory therapy&#xD;
&#xD;
             22. Anyone with poor venous access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Howard Gendelman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gendelman HE, Zhang Y, Santamaria P, Olson KE, Schutt CR, Bhatti D, Shetty BLD, Lu Y, Estes KA, Standaert DG, Heinrichs-Graham E, Larson L, Meza JL, Follett M, Forsberg E, Siuzdak G, Wilson TW, Peterson C, Mosley RL. Evaluation of the safety and immunomodulatory effects of sargramostim in a randomized, double-blind phase 1 clinical Parkinson's disease trial. NPJ Parkinsons Dis. 2017 Mar 23;3:10. doi: 10.1038/s41531-017-0013-5. eCollection 2017.</citation>
    <PMID>28649610</PMID>
  </reference>
  <reference>
    <citation>Saunders JA, Estes KA, Kosloski LM, Allen HE, Dempsey KM, Torres-Russotto DR, Meza JL, Santamaria PM, Bertoni JM, Murman DL, Ali HH, Standaert DG, Mosley RL, Gendelman HE. CD4+ regulatory and effector/memory T cell subsets profile motor dysfunction in Parkinson's disease. J Neuroimmune Pharmacol. 2012 Dec;7(4):927-38. doi: 10.1007/s11481-012-9402-z. Epub 2012 Oct 11.</citation>
    <PMID>23054369</PMID>
  </reference>
  <reference>
    <citation>Kosloski LM, Kosmacek EA, Olson KE, Mosley RL, Gendelman HE. GM-CSF induces neuroprotective and anti-inflammatory responses in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine intoxicated mice. J Neuroimmunol. 2013 Dec 15;265(1-2):1-10. doi: 10.1016/j.jneuroim.2013.10.009. Epub 2013 Oct 29.</citation>
    <PMID>24210793</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03790670
org study id: 0839-18-FB
nct id: NCT03790670
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
First, the investigators will determine the safety of a 36 month regimen of Leukine
      administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day
      holiday (weekend). This 36 month (n=10) pilot study will extend the prior 2 month observation
      tests towards the goal of assessing the safety of Leukine for treatment of Parkinson's
      disease (PD). 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).
      Second, we will assess regimen tolerability administered in a dose reduction, from 6
      µg/kg/day without interruption, to 3 µg/kg/day with 2 day drug holidays. The investigators
      will examine over a time of 36 months, effects of treatment on defined adaptive immune
      deficits in PD as measured by analysis of peripheral blood mononuclear cells collected
      before, during, and after cessation of Leukine administration. Individual T cell parameters
      will be assessed and will include links between T cell function and subset analyses and
      clinical neurological signs and symptoms. In addition, the functional stability of the immune
      deficits will be assess in PD by examining T cell subsets in PD patients in this study
      against prior results. The investigators will also determine whether the 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.
Primary Objectives: There are three study goals. First, the investigators will determine the
      safety of a 36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day
      for 5 days (week), followed by a 2-day holiday (weekend). This 36 month (n=10) pilot study
      will extend the prior 2 month observation tests towards the goal of assessing the safety of
      Leukine for treatment of Parkinson's disease (PD). 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). Second, the investigators will assess regimen
      tolerability administered in a dose reduction, from 6 µg/kg/day without interruption, to 3
      µg/kg/day with 2 day drug holidays. The lowered dose was chosen based on known tolerability
      and parallel-linked immune reconstitution seen in cancer-associated disease treatments. Due
      to fragility of the patient population and prior recorded adverse events the proposed dose
      reductions are justified.

      Secondary Objectives:

      Over a course of 36 months, the effects of treatment on defined adaptive immune deficits in
      PD as measured by analysis of peripheral blood mononuclear cells collected before, during,
      and after cessation of Leukine administration will be examined. Individual T cell parameters
      that include links between T cell function and subset analyses and clinical neurological
      signs and symptoms will be examined. These immune parameters will be serially examined as
      they may contribute to the immune deficits in PD. Thus, timed analyses of changes in T cell
      phenotypes and/or function will be completed. In addition, the investigators will assess the
      functional stability of the immune deficits in PD and will determine whether the immune
      deficits of PD are consistent during baseline data collection. The potential Leukine-induced
      motor control and mobility improvements will be determined by assessing UPDRS part I, II,
      III, and IV scores off treatment and on treatment. Specifically, over the course of this
      six-month treatment study, various biomarkers will be assessed including: T cell markers of
      immune activation, DNA methylation status, and B cell and bone marrow progenitor cell
      markers. We hope to uncover the time course of Treg induction, as well as link the
      pharmacokinetics of Leukine treatment (not previously recorded) to changes in specific
      biomarkers. Additionally, changes in the humoral response following extended Leukine
      treatment will be assessed by measuring the presence of antibodies against Leukine and
      alterations in B cell frequencies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Associated Adverse Events
time frame: monthly during the course of treatment, up to 36 months, followed by 1 month drug cessation
description: The safety of Leukine administration in PD will be examined by documenting abnormal results from CBC with differential, total T cell count, or comprehensive metabolic panel analyses; abnormal physical and or neurological exam findings; abnormal levels of antibodies to GM-CSF; clinically increasing Unified Parkinson's disease Rating Scale (UPDRS) part I, II, III, and IV scores as determined by the examining physician; and other adverse events. These safety assessments will be made every four weeks.
measure: Determination of Immune Cell Phenotype
time frame: 36 months of treatment, followed by 1 month drug cessation
description: Measurements will include change in CD45RO+ or FAS+ frequencies in CD4+ T cells; change in CD31+ frequencies in CD4+ T cells, Teff or Treg subsets; change in ItgB7+ frequencies in CD4+ T cells or the Teff subset; change in ItgB4B7+ frequencies in CD4+ T cells or the Treg subset; change in CD27+ frequencies in CD4+ T cells, Teff or Treg subsets, change in CCR7+ frequencies in CD4+ T cells, Teff or Treg subsets; change in FoxP3+ frequencies in CD4+ T cells, Teff or Treg subsets; change in CD34, CD117, or CD135 levels; change in DNA methylation status. The measurements will be combined to determine overall changes in immune cell frequency and T cell subset phenotype both on and off treatment.
measure: Determination of Immune Cell Number
time frame: 36 months of treatment, followed by 1 month drug cessation
description: Measurements will include changes in levels of lymphocytes or CD4+ T cells, as well as T cell, B cell, and bone marrow progenitor subsets.
measure: Determination of Immune Cell Function
time frame: 36 months of treatment, followed by 1 month drug cessation
description: Measurements will include changes in T cell function via proliferation and suppression assays and/or changes in B cell function via antibody production assessments.
arm group label: Leukine Treatment
arm group type: Experimental
description: 36 month regimen of Leukine administered as a weight-based dose at 3 µg/kg/day for 5 days (week), followed by a 2-day holiday (weekend)
intervention type: Drug
intervention name: sargramostim
description: Recombinant human GM-CSF produced by recombinant DNA technology using a yeast (S. cerevisiae) expression system
arm group label: Leukine Treatment
other name: Leukine
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Howard Gendelman, MD
role: Principal Investigator
affiliation: UNMC
facility: 
country: United States
citation: Gendelman HE, Zhang Y, Santamaria P, Olson KE, Schutt CR, Bhatti D, Shetty BLD, Lu Y, Estes KA, Standaert DG, Heinrichs-Graham E, Larson L, Meza JL, Follett M, Forsberg E, Siuzdak G, Wilson TW, Peterson C, Mosley RL. Evaluation of the safety and immunomodulatory effects of sargramostim in a randomized, double-blind phase 1 clinical Parkinson's disease trial. NPJ Parkinsons Dis. 2017 Mar 23;3:10. doi: 10.1038/s41531-017-0013-5. eCollection 2017.
PMID: 28649610
citation: Saunders JA, Estes KA, Kosloski LM, Allen HE, Dempsey KM, Torres-Russotto DR, Meza JL, Santamaria PM, Bertoni JM, Murman DL, Ali HH, Standaert DG, Mosley RL, Gendelman HE. CD4+ regulatory and effector/memory T cell subsets profile motor dysfunction in Parkinson's disease. J Neuroimmune Pharmacol. 2012 Dec;7(4):927-38. doi: 10.1007/s11481-012-9402-z. Epub 2012 Oct 11.
PMID: 23054369
citation: Kosloski LM, Kosmacek EA, Olson KE, Mosley RL, Gendelman HE. GM-CSF induces neuroprotective and anti-inflammatory responses in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine intoxicated mice. J Neuroimmunol. 2013 Dec 15;265(1-2):1-10. doi: 10.1016/j.jneuroim.2013.10.009. Epub 2013 Oct 29.
PMID: 24210793
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Sargramostim
sharing ipd: No