<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/NCT04506073</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-MS-20-0150</org_study_id>
    <nct_id>NCT04506073</nct_id>
  </id_info>
  <brief_title>Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Trial of Allogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Michael J. Fox Foundation for Parkinson's Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to select the safest and most effective number of repeat doses&#xD;
      of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the&#xD;
      progression of Parkinson's disease (PD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as&#xD;
      disease modifying therapy for PD. The design includes three treatment arms with 45 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Actual">July 30, 2023</completion_date>
  <primary_completion_date type="Actual">July 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Screening</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 7, post infusion #1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 20, post infusion #2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 29, post-infusion #3</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 39 follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 52 follow-up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale</measure>
    <time_frame>Week 78 follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability as measured by serious adverse reactions.</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability as measured by immunologic responses.</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
    <description>Donor specific antibodies (DSA) in serum of patients will be measured and compared to baseline to determine if there is a development of antibody response to donor HLA (human leukocyte antigen). This will determine if there is a possibility of anti-donor alloimmune response after the first or second infusion of MSC, which might lead to a subsequent antibody-mediated rejection (AMR) with the following infusion. Testing will be done at the these time points to determine if 2nd or 3rd infusions will continue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor function as measured by the Timed-Up-and-Go (TUG) scale</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
    <description>This test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A longer duration of time indicates a worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global measurement of disability as measured by the change in the screening &quot;Off&quot; modified Hoehn and Yahr (H&amp;Y)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by the modified Schwab and England activities of daily living scale (ADL)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by the Parkinson's Disease Questionnaire 39 (PDQ-39)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured by the EuroQol- 5 Dimension (EQ-5D)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-motor symtoms as measured by the The University of Pennsylvania Smell Identification Test (UPSIT- 40 odor test booklet).</measure>
    <time_frame>Baseline,week 29,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function as measured by the the change in Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Baseline,week 29,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral changes as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
    <description>The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. It rates an individual's degree of suicidal ideation on a scale, ranging from &quot;wish to be dead&quot; to &quot;active suicidal ideation with specific plan and intent&quot;. Exclusionary criteria views 1 or more positive answers in the last month as not eligible for participation. In follow up, one positive response requires further investigation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral changes as measured by the Geriatric Depression Scale-Short Form (GDS-SF)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
    <description>The Geriatric Depression Scale Short form (GDS-SF) is a 15-item screening tool that is used to identify depression in older adults. Answers indicating depression are in bold and italicized; score one point for each bold one selected. A score of 0 to 5 is normal. A score greater than 5 suggests depression and requires evaluation, whereas a score of 10 or greater would require evaluation for treatment .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral changes as measured by the Parkinson Anxiety Scale (PAS)</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 52,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs using neuroimaging</measure>
    <time_frame>Baseline,week 29,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by concentration of cytokines in patient blood sample.</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
    <description>Examples of these are IL-1beta, IL-6, TNF-alpha, COX-2 and PGE-2. These are measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by concentration of chemokines in patient blood sample.</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
    <description>Examples of these are CCL2 (MCP-1), CCL7 (MCP-3), CCL11 (Eotaxin) CCL2 (MDC), CXCL10 (IP-10), CX3CL1 (Fractalkine). These will be measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by concentration of growth factors</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
    <description>Examples of these are Glial Derived Neurotrophic Factor, Brain Derived Neurotrophic Factor and Vascular Epidermal Growth Factor . These will be measured by ELISA specific to blood and CSF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by concentration of neurotransmitters</measure>
    <time_frame>Baseline,week 7,week 20,week 29,week 39,week 78</time_frame>
    <description>Examples of these are homovanillic acid and 5-hydroxytryptamine. These will be measured in CSF and blood by ELISA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by alpha-synuclein oligomers in the blood (serum or plasma)</measure>
    <time_frame>Basleline,week 29,week 39,week 78</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of putative paracrine mechanism of MSCs as measured by alpha-synuclein oligomers in the cerebral spinal fluid</measure>
    <time_frame>Baseline,week 39</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>MSC+placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 treatment doses + 1 placebo 3 months apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MSC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 treatment doses 3 months apart</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 placebo doses 3 months apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MSC+placebo</intervention_name>
    <description>2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.</description>
    <arm_group_label>MSC+placebo</arm_group_label>
    <other_name>allogeneic mesenchymal stem cell or similar placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MSC</intervention_name>
    <description>3 infusions of 10 X 10^6 MSC/kg every 3 months.</description>
    <arm_group_label>MSC</arm_group_label>
    <other_name>allogeneic mesenchymal stem cell</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Similar placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Parkinson's disease by the UK brain bank criteria including the presence&#xD;
             of 2 cardinal signs of PD plus bradykinesia.&#xD;
&#xD;
          -  Mild microsomia to anosmia.&#xD;
&#xD;
          -  A modified Hoehn and Yahr stage of 3 or less.&#xD;
&#xD;
          -  Date of diagnosis of PD between 3 to 10 years&#xD;
&#xD;
          -  Robust response to dopaminergic therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atypical, vascular, or drug-induced Parkinsonism.&#xD;
&#xD;
          -  An atypical DAT scan or MRI supporting an alternative explanation for PD symptoms.&#xD;
&#xD;
          -  Patient not on levodopa containing medications.&#xD;
&#xD;
          -  Clinical features of psychosis or refractory hallucinations.&#xD;
&#xD;
          -  A Montreal Cognitive Assessment (MoCA) score of less than 25.&#xD;
&#xD;
          -  Uncontrolled seizure disorder.&#xD;
&#xD;
          -  Abnormal Kidney and liver function.&#xD;
&#xD;
          -  Presence of clinically refractory orthostatic hypotension at the screening or baseline&#xD;
             visit.&#xD;
&#xD;
          -  Body mass index of greater than or equal to 35.&#xD;
&#xD;
          -  Cardiac disease: History of congestive heart failure, clinically significant&#xD;
             bradycardia, presence of 2nd, or 3rd-degree atrioventricular block.&#xD;
&#xD;
          -  Pulmonary disease: COPD with oxygen-requirement at rest or with ambulation; or&#xD;
             moderate to severe asthma.&#xD;
&#xD;
          -  Active malignancy or diagnosis of malignancy within 5 years prior to the start of&#xD;
             screening&#xD;
&#xD;
          -  Any current suicidal ideation or behaviors.&#xD;
&#xD;
          -  Any diagnosis of autoimmune disease or immunocompromised state&#xD;
&#xD;
          -  History of medium or large size vessel cerebrovascular accidents.&#xD;
&#xD;
          -  History of traumatic brain injury with loss of consciousness and residual neurologic&#xD;
             symptoms.&#xD;
&#xD;
          -  Major surgery within the previous 3 months or planned in the ensuing 6 months.&#xD;
&#xD;
          -  History of use of an investigational drug within 90 days prior to the screening visit.&#xD;
&#xD;
          -  History of brain surgery for PD.&#xD;
&#xD;
          -  Substance abuse disorder.&#xD;
&#xD;
          -  Active anticoagulation treatment and/or abnormal INR.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mya C Schiess, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.</citation>
    <PMID>30584159</PMID>
  </reference>
  <reference>
    <citation>Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.</citation>
    <PMID>12498954</PMID>
  </reference>
  <reference>
    <citation>Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654.</citation>
    <PMID>24756517</PMID>
  </reference>
  <reference>
    <citation>Jellinger KA. Basic mechanisms of neurodegeneration: a critical update. J Cell Mol Med. 2010 Mar;14(3):457-87. doi: 10.1111/j.1582-4934.2010.01010.x. Epub 2010 Jan 11.</citation>
    <PMID>20070435</PMID>
  </reference>
  <reference>
    <citation>Kortekaas R, Leenders KL, van Oostrom JC, Vaalburg W, Bart J, Willemsen AT, Hendrikse NH. Blood-brain barrier dysfunction in parkinsonian midbrain in vivo. Ann Neurol. 2005 Feb;57(2):176-9. doi: 10.1002/ana.20369.</citation>
    <PMID>15668963</PMID>
  </reference>
  <reference>
    <citation>Gray MT, Woulfe JM. Striatal blood-brain barrier permeability in Parkinson's disease. J Cereb Blood Flow Metab. 2015 May;35(5):747-50. doi: 10.1038/jcbfm.2015.32. Epub 2015 Mar 11.</citation>
    <PMID>25757748</PMID>
  </reference>
  <reference>
    <citation>Orr CF, Rowe DB, Halliday GM. An inflammatory review of Parkinson's disease. Prog Neurobiol. 2002 Dec;68(5):325-40. doi: 10.1016/s0301-0082(02)00127-2.</citation>
    <PMID>12531233</PMID>
  </reference>
  <reference>
    <citation>Nagatsu T, Mogi M, Ichinose H, Togari A. Cytokines in Parkinson's disease. J Neural Transm Suppl. 2000;(58):143-51.</citation>
    <PMID>11128604</PMID>
  </reference>
  <reference>
    <citation>Stypula G, Kunert-Radek J, Stepien H, Zylinska K, Pawlikowski M. Evaluation of interleukins, ACTH, cortisol and prolactin concentrations in the blood of patients with parkinson's disease. Neuroimmunomodulation. 1996 Mar-Jun;3(2-3):131-4. doi: 10.1159/000097237.</citation>
    <PMID>8945728</PMID>
  </reference>
  <reference>
    <citation>Joyce N, Annett G, Wirthlin L, Olson S, Bauer G, Nolta JA. Mesenchymal stem cells for the treatment of neurodegenerative disease. Regen Med. 2010 Nov;5(6):933-46. doi: 10.2217/rme.10.72.</citation>
    <PMID>21082892</PMID>
  </reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Mya Schiess</investigator_full_name>
    <investigator_title>Professor and Adriana Blood Chair in Neurology</investigator_title>
  </responsible_party>
  <keyword>Stem Cells</keyword>
  <keyword>Mesenchymal stem cells</keyword>
  <keyword>Inflammatory markers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_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/NCT04506073
org study id: HSC-MS-20-0150
nct id: NCT04506073
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to select the safest and most effective number of repeat doses
      of allogeneic bone marrow-derived mesenchymal stem cell (MSC) infusions to slow the
      progression of Parkinson's disease (PD).
Single site phase IIa study of allogeneic MSC in a double blind randomized control trial as
      disease modifying therapy for PD. The design includes three treatment arms with 45 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Screening
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 7, post infusion #1
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 20, post infusion #2
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 29, post-infusion #3
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 39 follow-up
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 52 follow-up
measure: Safest number of effective doses of MSC as measured by the Part III of the Movement Disorder Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) scale
time frame: Week 78 follow-up
measure: Safety and tolerability as measured by serious adverse reactions.
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
measure: Safety and tolerability as measured by immunologic responses.
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
description: Donor specific antibodies (DSA) in serum of patients will be measured and compared to baseline to determine if there is a development of antibody response to donor HLA (human leukocyte antigen). This will determine if there is a possibility of anti-donor alloimmune response after the first or second infusion of MSC, which might lead to a subsequent antibody-mediated rejection (AMR) with the following infusion. Testing will be done at the these time points to determine if 2nd or 3rd infusions will continue.
measure: Motor function as measured by the Timed-Up-and-Go (TUG) scale
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
description: This test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A longer duration of time indicates a worse outcome
measure: Global measurement of disability as measured by the change in the screening "Off" modified Hoehn and Yahr (H&Y)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
measure: Quality of life as measured by the modified Schwab and England activities of daily living scale (ADL)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
measure: Quality of life as measured by the Parkinson's Disease Questionnaire 39 (PDQ-39)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
measure: Quality of life as measured by the EuroQol- 5 Dimension (EQ-5D)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
measure: Non-motor symtoms as measured by the The University of Pennsylvania Smell Identification Test (UPSIT- 40 odor test booklet).
time frame: Baseline,week 29,week 78
measure: Cognitive function as measured by the the change in Montreal Cognitive Assessment (MoCA)
time frame: Baseline,week 29,week 78
measure: Behavioral changes as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent". Exclusionary criteria views 1 or more positive answers in the last month as not eligible for participation. In follow up, one positive response requires further investigation.
measure: Behavioral changes as measured by the Geriatric Depression Scale-Short Form (GDS-SF)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
description: The Geriatric Depression Scale Short form (GDS-SF) is a 15-item screening tool that is used to identify depression in older adults. Answers indicating depression are in bold and italicized; score one point for each bold one selected. A score of 0 to 5 is normal. A score greater than 5 suggests depression and requires evaluation, whereas a score of 10 or greater would require evaluation for treatment .
measure: Behavioral changes as measured by the Parkinson Anxiety Scale (PAS)
time frame: Baseline,week 7,week 20,week 29,week 39,week 52,week 78
measure: Measurement of putative paracrine mechanism of MSCs using neuroimaging
time frame: Baseline,week 29,week 78
measure: Measurement of putative paracrine mechanism of MSCs as measured by concentration of cytokines in patient blood sample.
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
description: Examples of these are IL-1beta, IL-6, TNF-alpha, COX-2 and PGE-2. These are measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.
measure: Measurement of putative paracrine mechanism of MSCs as measured by concentration of chemokines in patient blood sample.
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
description: Examples of these are CCL2 (MCP-1), CCL7 (MCP-3), CCL11 (Eotaxin) CCL2 (MDC), CXCL10 (IP-10), CX3CL1 (Fractalkine). These will be measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.
measure: Measurement of putative paracrine mechanism of MSCs as measured by concentration of growth factors
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
description: Examples of these are Glial Derived Neurotrophic Factor, Brain Derived Neurotrophic Factor and Vascular Epidermal Growth Factor . These will be measured by ELISA specific to blood and CSF.
measure: Measurement of putative paracrine mechanism of MSCs as measured by concentration of neurotransmitters
time frame: Baseline,week 7,week 20,week 29,week 39,week 78
description: Examples of these are homovanillic acid and 5-hydroxytryptamine. These will be measured in CSF and blood by ELISA.
measure: Measurement of putative paracrine mechanism of MSCs as measured by alpha-synuclein oligomers in the blood (serum or plasma)
time frame: Basleline,week 29,week 39,week 78
measure: Measurement of putative paracrine mechanism of MSCs as measured by alpha-synuclein oligomers in the cerebral spinal fluid
time frame: Baseline,week 39
arm group label: MSC+placebo
arm group type: Experimental
description: 2 treatment doses + 1 placebo 3 months apart
arm group label: MSC
arm group type: Experimental
description: 3 treatment doses 3 months apart
arm group label: Placebo
arm group type: Placebo Comparator
description: 3 placebo doses 3 months apart
intervention type: Drug
intervention name: MSC+placebo
description: 2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
arm group label: MSC+placebo
other name: allogeneic mesenchymal stem cell or similar placebo
intervention type: Drug
intervention name: MSC
description: 3 infusions of 10 X 10^6 MSC/kg every 3 months.
arm group label: MSC
other name: allogeneic mesenchymal stem cell
intervention type: Drug
intervention name: Placebo
description: 3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.
arm group label: Placebo
other name: Similar placebo
criteria: 
gender: All
minimum age: 50 Years
maximum age: 79 Years
healthy volunteers: No
last name: Mya C Schiess, MD
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
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PMID: 25757748
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PMID: 12531233
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PMID: 21082892
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Mya Schiess
investigator title: Professor and Adriana Blood Chair in Neurology
mesh term: Parkinson Disease
sharing ipd: No