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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01734733
Registration number
NCT01734733
Ethics application status
Date submitted
18/11/2012
Date registered
28/11/2012
Date last updated
9/06/2020
Titles & IDs
Public title
Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease
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Scientific 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
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Secondary ID [1]
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LCT/PD-012
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
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Condition category
Condition code
Neurological
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Parkinson's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NTCELL
Experimental: NTCELL - 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.
Other interventions: NTCELL
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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the safety of xenotransplantation of NTCELL
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Assessment method [1]
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measured by the incidence of adverse events, clinical laboratory tests (including xenogeneic viral analysis), physical examination, review by infectious disease physician
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Timepoint [1]
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26 weeks
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Secondary outcome [1]
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Brain metabolism as demonstrated on PET with [18F]-fluorodopa measured at 26 weeks post-implant 1 compared with baseline
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Assessment method [1]
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Timepoint [1]
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26 weeks
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Secondary outcome [2]
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Brain metabolism as demonstrated on PET with [11C]-tetrabenazine measured at 26 weeks post-implant 1 compared with baseline
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Assessment method [2]
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Timepoint [2]
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26 weeks
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Secondary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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26 weeks
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Secondary outcome [4]
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Modified Hoehn and Yahr stages over 26 weeks post-implant 1 compared with the baseline stages
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Assessment method [4]
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Timepoint [4]
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26 weeks
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Secondary outcome [5]
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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
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Assessment method [5]
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Timepoint [5]
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26 weeks
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Secondary outcome [6]
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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
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Assessment method [6]
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Timepoint [6]
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26 weeks
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Secondary outcome [7]
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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
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Assessment method [7]
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Timepoint [7]
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26 weeks
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Secondary outcome [8]
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Scores measured by the Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-implant 1 compared with the baseline scores
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Assessment method [8]
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Timepoint [8]
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26 weeks
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Secondary outcome [9]
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Scores measured by neuropsychological tests at 26 weeks post-implant 1 compared with the baseline scores
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Assessment method [9]
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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
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Timepoint [9]
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26 weeks
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Secondary outcome [10]
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Psychiatric assessment at 26 weeks post-implant 1 compared with the baseline psychiatric assessment
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Assessment method [10]
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Timepoint [10]
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26 weeks
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Eligibility
Key inclusion criteria
To be assessed at the Week -10 to -4 Visit
- Adults (males or females) in the age range 40 to 70 years
- Diagnosis of Parkinson's disease (minimum duration of 5 years) in accordance with the
London Brain Bank criteria
- Patients diagnosed with idiopathic Parkinson's disease
- Stable medication for Parkinson's for at least 1 month
- Patients with advanced and fluctuating Parkinson's disease who have met the criteria
for DBS and who have been accepted for DBS at Auckland City Hospital. These criteria
include exhaustion of available medication treatments for Parkinson's disease, normal
brain MRI, intact cognitive, psychological and psychiatric function, appropriate carer
support, and competence and willingness to consent to the placement of deep brain
probes
- If female, no childbearing capability (those who are more than 2 years postmenopausal
or have undergone voluntary sterilisation can be considered for enrolment)
- Provision of written informed consent. Patients will be required to agree to comply
with all tests and visits specified in the protocol, and they (and their
partners/close contacts) will also be required to consent to long-term microbiological
monitoring, which is an integral part of the study.
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
To be assessed at the Week -10 to -4 Visit
Note: the criteria for acceptance for DBS would exclude patients with comorbidities that
normally would exclude them from similar studies, including uncontrolled depression,
dementia, focal neurological deficits, or secondary parkinsonism. Specific exclusion
criteria in this category are:
- Any history of central nervous system infection
- Significant dementia as determined by neuropsychological assessment
- Focal neurological defects
- Evidence of significant medical or psychiatric disorders
- Secondary parkinsonism
- Severe autonomic symptoms
- Atypical Parkinson's disease
- History of substance abuse
- Body mass index (BMI) =30 kg/m2 or =20 kg/m2
- Serious comorbid conditions that are likely to affect participation in the study,
including:
- Previous coronary heart disease manifesting as non-ST elevation myocardial
infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass
graft (CABG); or percutaneous angioplasty
- Previous cerebrovascular disease manifesting as transient ischaemic attacks
(TIAs) or stroke
- Peripheral vascular disease with foot ulcer and/or previous amputation
- History of New York Heart Association (NYHA) class II, III or IV congestive heart
failure (CHF) and/or chronic atrial fibrillation
- Chronic obstructive pulmonary disease (COPD) or asthma with previous
hospitalisation for decompensation; a requirement for mechanical ventilation at
any stage; or long-term treatment with oral corticosteroids
- Liver disease with abnormal liver function tests defined as serum bilirubin =20
µmol/L, and/or ALT =100 U/L, and/or GGT =100 U/L, and/or albumin < 35 g/L
- Haematological disorders, including haemoglobin =110 g/L or platelet count < 80 x
109/L
- Kidney disease, defined as serum creatinine > 130 µmol/L in men and > 110 µmol/L
in women and/or haematuria and/or active urinary sediment or casts
- Peptic ulcer disease and/or history of previous gastrointestinal bleeding
- Malignancy other than basal cell carcinoma
- History of epilepsy
- Untreated hypothyroidism
- Known adrenal insufficiency
Other exclusion criteria:
- Past history of brain surgery for Parkinson's disease
- Poor candidate for any surgery
- HIV antibody and/or risk factors for HIV infection
- Positive hepatitis C antibody, positive hepatitis B surface antigen, and hepatitis B
core antibody
- Current administration of immunosuppressive medications (e.g. cyclosporin, tacrolimus,
sirolimus, mycophenolate mofetil, muromonab-CD3, daclizumab, basiliximab,
antithymocyte globulin, interferons) for other disease conditions
- Inability to travel on aeroplane to Vancouver (for PET scan)
- Any other condition that, in the opinion of the Investigator, may interfere with
adherence to the study protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/06/2020
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Sample size
Target
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Living Cell Technologies
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01734733
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barry Snow, MBChB
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Address
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Auckland City Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01734733
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