<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/NCT01734733</url>
  </required_header>
  <id_info>
    <org_study_id>LCT/PD-012</org_study_id>
    <nct_id>NCT01734733</nct_id>
  </id_info>
  <brief_title>Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease</brief_title>
  <official_title>A Phase I/IIa, Open-label Investigation of the Safety and Clinical Effects of NTCELL [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Living Cell Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Living Cell Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the safety of xenotransplantation of NTCELL [immunoprotected&#xD;
      (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed&#xD;
      over the duration of the study, by monitoring the occurrence of adverse events and serious&#xD;
      adverse events, including clinical and laboratory evidence of xenogeneic infection in&#xD;
      transplant recipients and their partners/close contacts. Subsequent safety follow-up will&#xD;
      include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.&#xD;
&#xD;
      To assess the clinical effects of NTCELL [immunoprotected (alginate-encapsulated) choroid&#xD;
      plexus cells] in patients with Parkinson's disease. This will be quantified by testing the&#xD;
      secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease is characterized by widespread neural degeneration, particularly in the&#xD;
      substantia nigra and its projections to the basal ganglia. Current therapy for Parkinson's&#xD;
      disease is purely symptomatic. There is a pressing need for a treatment that reverses or&#xD;
      slows the degeneration of the nigrostriatal pathway.&#xD;
&#xD;
      Numerous transplant-based therapies have attempted to support, repair or replace the&#xD;
      degenerating nigrostriatal neurons. These have included the transplantation of foetal and&#xD;
      other neuronal stem cells, gene transfers, and the implantation of devices releasing neural&#xD;
      growth factors. All these have been shown to have some effectiveness in animal models, but&#xD;
      have been generally disappointing in human studies.&#xD;
&#xD;
      Intracranial choroid plexus cell transplantation has the potential to deliver biological&#xD;
      neural agents for the treatment of Parkinson's disease which cannot be achieved by&#xD;
      conventional treatment. The overall aim of delivering neural proteins and compounds over many&#xD;
      months to the basal ganglia of the brain is to enhance neural repair currently not possible&#xD;
      with antiparkinsonian medication or deep brain stimulation (DBS).&#xD;
&#xD;
      As animal-derived tissues have to be protected from immune rejection when transplanted into&#xD;
      humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine&#xD;
      choroid plexus cells are preferably implanted without the use of immunosuppressive drugs&#xD;
      which cause significant morbidity. To protect them from immune rejection, the cells can be&#xD;
      encapsulated in alginate microcapsules which permit the inward passage of nutrients and the&#xD;
      outward passage of biologic neural proteins and compounds normally secreted by choroid plexus&#xD;
      cells. Alginate-encapsulated porcine choroid plexus cells implanted into the brain without&#xD;
      immunosuppressive drugs have survived rejection for many months in animal studies.&#xD;
&#xD;
      NTCELL comprises neonatal porcine choroid plexus cells encapsulated in alginate&#xD;
      microcapsules. NTCELL has been safely implanted in rats, and non-human primates. Following&#xD;
      NTCELL implants, animals with chemically-induced Parkinson's-like lesions showed improvement&#xD;
      of functional neurological motor abnormalities that was associated with histologic changes&#xD;
      consistent with amelioration of the lesion.&#xD;
&#xD;
      The initial dose for intracranial implantation of the current NTCELL preparation for the&#xD;
      treatment of Parkinson's disease in humans is based on the effective dose in a non-human&#xD;
      primate (rhesus monkey) model.&#xD;
&#xD;
      Parkinson's disease patients will be followed up for 26 weeks after receiving an implantation&#xD;
      of NTCELL administered into the putamen of the corpus striatum on the side contralateral to&#xD;
      the greatest clinical deficit.&#xD;
&#xD;
      Based upon the data obtained during the 26-week follow-up period a decision will be made as&#xD;
      to whether the patient will receive:&#xD;
&#xD;
        -  an implantation of a second dose of NTCELL&#xD;
&#xD;
        -  unilateral DBS&#xD;
&#xD;
        -  bilateral DBS&#xD;
&#xD;
        -  no further intervention&#xD;
&#xD;
      The data will be reviewed by the investigators and the Data Safety Monitoring Board (DSMB),&#xD;
      the data will consist of clinical outcomes and clinimetric data, an MRI scan, PET scanning,&#xD;
      and adverse events.&#xD;
&#xD;
      Patients will be followed up for a further 48 weeks if there is no further intervention,&#xD;
      however if it is decided that either DBS or implantation of a second dose of NTCELL occurs&#xD;
      then the frequency of follow-up will be the subject of a protocol amendment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2013</start_date>
  <completion_date type="Actual">June 4, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>the safety of xenotransplantation of NTCELL</measure>
    <time_frame>26 weeks</time_frame>
    <description>measured by the incidence of adverse events, clinical laboratory tests (including xenogeneic viral analysis), physical examination, review by infectious disease physician</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain metabolism as demonstrated on PET with [18F]-fluorodopa measured at 26 weeks post-implant 1 compared with baseline</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain metabolism as demonstrated on PET with [11C]-tetrabenazine measured at 26 weeks post-implant 1 compared with baseline</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores measured by the Unified Parkinson's Disease Rating Scale (UPDRS Parts I, II, III, IV - Parts II and III will be performed in the 'off' and 'on' state) over 26 weeks post-implant 1 compared with the baseline scores</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Hoehn and Yahr stages over 26 weeks post-implant 1 compared with the baseline stages</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores measured by the Unified Dyskinesia Rating Scale (UDysRS Parts I, II, III, IV - Parts III and IV will be performed in the 'off' and 'on' state) over 26 weeks post-implant 1 compared with the baseline scores</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Times for hand-arm movement between 2 points (tapping test) in accordance with the CAPSIT-PD protocol (Defer et al. 1999) over 26 weeks post-implant 1 compared with the baseline times</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores measured by the modified walking test in accordance with the CAPSIT-PD protocol (Defer et al. 1999) (walking 4.5m back and forth instead of 7m back and forth) over 26 weeks post-implant 1 compared with the baseline scores</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores measured by the Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-implant 1 compared with the baseline scores</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores measured by neuropsychological tests at 26 weeks post-implant 1 compared with the baseline scores</measure>
    <time_frame>26 weeks</time_frame>
    <description>TESTS USED&#xD;
National Adult Reading Test&#xD;
Speed and Capacity of Language Processing Test&#xD;
Boston Naming Test&#xD;
Trail Making Test A&#xD;
Trail Making Test B&#xD;
WMS IV Logical Memory I&#xD;
WMS IV Logical Memory II&#xD;
RAVLT List Learning&#xD;
RAVLT Short Delay Recall&#xD;
RAVLT Long Delay Recall&#xD;
Rey Complex Figure Copy&#xD;
Rey Complex Figure Delayed Recall&#xD;
WAIS IV Digit Span&#xD;
WAIS IV Matrix Reasoning&#xD;
WAIS IV Symbol Search&#xD;
WAIS IV Coding&#xD;
DKEFS Word Fluency&#xD;
DKEFS Category Fluency&#xD;
DKEFS Category Switching&#xD;
DKEFS Colour Naming&#xD;
DKEFS Word Reading&#xD;
DKEFS Inhibition&#xD;
DKEFS Inhibition/switching&#xD;
Mini Mental State Examination&#xD;
Montreal Cognitive Assessment&#xD;
HADS Anxiety&#xD;
HADS Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychiatric assessment at 26 weeks post-implant 1 compared with the baseline psychiatric assessment</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>NTCELL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NTCELL 40 microcapsules (+/- 20%)&#xD;
The NTCELL microcapsules are drawn up into a catheter system and introduced intracranially by stereotactic insertion into the brain under guidance by neuroimaging.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NTCELL</intervention_name>
    <arm_group_label>NTCELL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be assessed at the Week -10 to -4 Visit&#xD;
&#xD;
          -  Adults (males or females) in the age range 40 to 70 years&#xD;
&#xD;
          -  Diagnosis of Parkinson's disease (minimum duration of 5 years) in accordance with the&#xD;
             London Brain Bank criteria&#xD;
&#xD;
          -  Patients diagnosed with idiopathic Parkinson's disease&#xD;
&#xD;
          -  Stable medication for Parkinson's for at least 1 month&#xD;
&#xD;
          -  Patients with advanced and fluctuating Parkinson's disease who have met the criteria&#xD;
             for DBS and who have been accepted for DBS at Auckland City Hospital. These criteria&#xD;
             include exhaustion of available medication treatments for Parkinson's disease, normal&#xD;
             brain MRI, intact cognitive, psychological and psychiatric function, appropriate carer&#xD;
             support, and competence and willingness to consent to the placement of deep brain&#xD;
             probes&#xD;
&#xD;
          -  If female, no childbearing capability (those who are more than 2 years postmenopausal&#xD;
             or have undergone voluntary sterilisation can be considered for enrolment)&#xD;
&#xD;
          -  Provision of written informed consent. Patients will be required to agree to comply&#xD;
             with all tests and visits specified in the protocol, and they (and their&#xD;
             partners/close contacts) will also be required to consent to long-term microbiological&#xD;
             monitoring, which is an integral part of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        To be assessed at the Week -10 to -4 Visit&#xD;
&#xD;
        Note: the criteria for acceptance for DBS would exclude patients with comorbidities that&#xD;
        normally would exclude them from similar studies, including uncontrolled depression,&#xD;
        dementia, focal neurological deficits, or secondary parkinsonism. Specific exclusion&#xD;
        criteria in this category are:&#xD;
&#xD;
          -  Any history of central nervous system infection&#xD;
&#xD;
          -  Significant dementia as determined by neuropsychological assessment&#xD;
&#xD;
          -  Focal neurological defects&#xD;
&#xD;
          -  Evidence of significant medical or psychiatric disorders&#xD;
&#xD;
          -  Secondary parkinsonism&#xD;
&#xD;
          -  Severe autonomic symptoms&#xD;
&#xD;
          -  Atypical Parkinson's disease&#xD;
&#xD;
          -  History of substance abuse&#xD;
&#xD;
          -  Body mass index (BMI) ≥30 kg/m2 or ≤20 kg/m2&#xD;
&#xD;
          -  Serious comorbid conditions that are likely to affect participation in the study,&#xD;
             including:&#xD;
&#xD;
               -  Previous coronary heart disease manifesting as non-ST elevation myocardial&#xD;
                  infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass&#xD;
                  graft (CABG); or percutaneous angioplasty&#xD;
&#xD;
               -  Previous cerebrovascular disease manifesting as transient ischaemic attacks&#xD;
                  (TIAs) or stroke&#xD;
&#xD;
               -  Peripheral vascular disease with foot ulcer and/or previous amputation&#xD;
&#xD;
               -  History of New York Heart Association (NYHA) class II, III or IV congestive heart&#xD;
                  failure (CHF) and/or chronic atrial fibrillation&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease (COPD) or asthma with previous&#xD;
                  hospitalisation for decompensation; a requirement for mechanical ventilation at&#xD;
                  any stage; or long-term treatment with oral corticosteroids&#xD;
&#xD;
               -  Liver disease with abnormal liver function tests defined as serum bilirubin ≥20&#xD;
                  µmol/L, and/or ALT ≥100 U/L, and/or GGT ≥100 U/L, and/or albumin &lt; 35 g/L&#xD;
&#xD;
               -  Haematological disorders, including haemoglobin ≤110 g/L or platelet count &lt; 80 x&#xD;
                  109/L&#xD;
&#xD;
               -  Kidney disease, defined as serum creatinine &gt; 130 μmol/L in men and &gt; 110 μmol/L&#xD;
                  in women and/or haematuria and/or active urinary sediment or casts&#xD;
&#xD;
               -  Peptic ulcer disease and/or history of previous gastrointestinal bleeding&#xD;
&#xD;
               -  Malignancy other than basal cell carcinoma&#xD;
&#xD;
               -  History of epilepsy&#xD;
&#xD;
               -  Untreated hypothyroidism&#xD;
&#xD;
               -  Known adrenal insufficiency&#xD;
&#xD;
        Other exclusion criteria:&#xD;
&#xD;
          -  Past history of brain surgery for Parkinson's disease&#xD;
&#xD;
          -  Poor candidate for any surgery&#xD;
&#xD;
          -  HIV antibody and/or risk factors for HIV infection&#xD;
&#xD;
          -  Positive hepatitis C antibody, positive hepatitis B surface antigen, and hepatitis B&#xD;
             core antibody&#xD;
&#xD;
          -  Current administration of immunosuppressive medications (e.g. cyclosporin, tacrolimus,&#xD;
             sirolimus, mycophenolate mofetil, muromonab-CD3, daclizumab, basiliximab,&#xD;
             antithymocyte globulin, interferons) for other disease conditions&#xD;
&#xD;
          -  Inability to travel on aeroplane to Vancouver (for PET scan)&#xD;
&#xD;
          -  Any other condition that, in the opinion of the Investigator, may interfere with&#xD;
             adherence to the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barry Snow, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Auckland City Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <link>
    <url>http://www.lctglobal.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Xenotransplantation</keyword>
  <keyword>choroid plexus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01734733
org study id: LCT/PD-012
nct id: NCT01734733
lead sponsor: 
has dmc: Yes
To assess the safety of xenotransplantation of NTCELL [immunoprotected
      (alginate-encapsulated) choroid plexus cells] in patients with Parkinson's disease, assessed
      over the duration of the study, by monitoring the occurrence of adverse events and serious
      adverse events, including clinical and laboratory evidence of xenogeneic infection in
      transplant recipients and their partners/close contacts. Subsequent safety follow-up will
      include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.

      To assess the clinical effects of NTCELL [immunoprotected (alginate-encapsulated) choroid
      plexus cells] in patients with Parkinson's disease. This will be quantified by testing the
      secondary endpoints of the trial as described below (see Endpoints/Outcome Measures).
Parkinson's disease is characterized by widespread neural degeneration, particularly in the
      substantia nigra and its projections to the basal ganglia. Current therapy for Parkinson's
      disease is purely symptomatic. There is a pressing need for a treatment that reverses or
      slows the degeneration of the nigrostriatal pathway.

      Numerous transplant-based therapies have attempted to support, repair or replace the
      degenerating nigrostriatal neurons. These have included the transplantation of foetal and
      other neuronal stem cells, gene transfers, and the implantation of devices releasing neural
      growth factors. All these have been shown to have some effectiveness in animal models, but
      have been generally disappointing in human studies.

      Intracranial choroid plexus cell transplantation has the potential to deliver biological
      neural agents for the treatment of Parkinson's disease which cannot be achieved by
      conventional treatment. The overall aim of delivering neural proteins and compounds over many
      months to the basal ganglia of the brain is to enhance neural repair currently not possible
      with antiparkinsonian medication or deep brain stimulation (DBS).

      As animal-derived tissues have to be protected from immune rejection when transplanted into
      humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine
      choroid plexus cells are preferably implanted without the use of immunosuppressive drugs
      which cause significant morbidity. To protect them from immune rejection, the cells can be
      encapsulated in alginate microcapsules which permit the inward passage of nutrients and the
      outward passage of biologic neural proteins and compounds normally secreted by choroid plexus
      cells. Alginate-encapsulated porcine choroid plexus cells implanted into the brain without
      immunosuppressive drugs have survived rejection for many months in animal studies.

      NTCELL comprises neonatal porcine choroid plexus cells encapsulated in alginate
      microcapsules. NTCELL has been safely implanted in rats, and non-human primates. Following
      NTCELL implants, animals with chemically-induced Parkinson's-like lesions showed improvement
      of functional neurological motor abnormalities that was associated with histologic changes
      consistent with amelioration of the lesion.

      The initial dose for intracranial implantation of the current NTCELL preparation for the
      treatment of Parkinson's disease in humans is based on the effective dose in a non-human
      primate (rhesus monkey) model.

      Parkinson's disease patients will be followed up for 26 weeks after receiving an implantation
      of NTCELL administered into the putamen of the corpus striatum on the side contralateral to
      the greatest clinical deficit.

      Based upon the data obtained during the 26-week follow-up period a decision will be made as
      to whether the patient will receive:

        -  an implantation of a second dose of NTCELL

        -  unilateral DBS

        -  bilateral DBS

        -  no further intervention

      The data will be reviewed by the investigators and the Data Safety Monitoring Board (DSMB),
      the data will consist of clinical outcomes and clinimetric data, an MRI scan, PET scanning,
      and adverse events.

      Patients will be followed up for a further 48 weeks if there is no further intervention,
      however if it is decided that either DBS or implantation of a second dose of NTCELL occurs
      then the frequency of follow-up will be the subject of a protocol amendment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the safety of xenotransplantation of NTCELL
time frame: 26 weeks
description: measured by the incidence of adverse events, clinical laboratory tests (including xenogeneic viral analysis), physical examination, review by infectious disease physician
measure: Brain metabolism as demonstrated on PET with [18F]-fluorodopa measured at 26 weeks post-implant 1 compared with baseline
time frame: 26 weeks
measure: Brain metabolism as demonstrated on PET with [11C]-tetrabenazine measured at 26 weeks post-implant 1 compared with baseline
time frame: 26 weeks
measure: Scores measured by the Unified Parkinson's Disease Rating Scale (UPDRS Parts I, II, III, IV - Parts II and III will be performed in the 'off' and 'on' state) over 26 weeks post-implant 1 compared with the baseline scores
time frame: 26 weeks
measure: Modified Hoehn and Yahr stages over 26 weeks post-implant 1 compared with the baseline stages
time frame: 26 weeks
measure: Scores measured by the Unified Dyskinesia Rating Scale (UDysRS Parts I, II, III, IV - Parts III and IV will be performed in the 'off' and 'on' state) over 26 weeks post-implant 1 compared with the baseline scores
time frame: 26 weeks
measure: Times for hand-arm movement between 2 points (tapping test) in accordance with the CAPSIT-PD protocol (Defer et al. 1999) over 26 weeks post-implant 1 compared with the baseline times
time frame: 26 weeks
measure: Scores measured by the modified walking test in accordance with the CAPSIT-PD protocol (Defer et al. 1999) (walking 4.5m back and forth instead of 7m back and forth) over 26 weeks post-implant 1 compared with the baseline scores
time frame: 26 weeks
measure: Scores measured by the Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-implant 1 compared with the baseline scores
time frame: 26 weeks
measure: Scores measured by neuropsychological tests at 26 weeks post-implant 1 compared with the baseline scores
time frame: 26 weeks
description: TESTS USED
National Adult Reading Test
Speed and Capacity of Language Processing Test
Boston Naming Test
Trail Making Test A
Trail Making Test B
WMS IV Logical Memory I
WMS IV Logical Memory II
RAVLT List Learning
RAVLT Short Delay Recall
RAVLT Long Delay Recall
Rey Complex Figure Copy
Rey Complex Figure Delayed Recall
WAIS IV Digit Span
WAIS IV Matrix Reasoning
WAIS IV Symbol Search
WAIS IV Coding
DKEFS Word Fluency
DKEFS Category Fluency
DKEFS Category Switching
DKEFS Colour Naming
DKEFS Word Reading
DKEFS Inhibition
DKEFS Inhibition/switching
Mini Mental State Examination
Montreal Cognitive Assessment
HADS Anxiety
HADS Depression
measure: Psychiatric assessment at 26 weeks post-implant 1 compared with the baseline psychiatric assessment
time frame: 26 weeks
arm group label: NTCELL
arm group type: Experimental
description: NTCELL 40 microcapsules (+/- 20%)
The NTCELL microcapsules are drawn up into a catheter system and introduced intracranially by stereotactic insertion into the brain under guidance by neuroimaging.
intervention type: Other
intervention name: NTCELL
arm group label: NTCELL
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Barry Snow, MBChB
role: Principal Investigator
affiliation: Auckland City Hospital
facility: 
country: New Zealand
url: http://www.lctglobal.com/
description: Related Info
responsible party type: Sponsor
mesh term: Parkinson Disease