Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's Disease, Xenotransplantation, choroid plexus
Eligibility Criteria
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.
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.
Sites / Locations
- Auckland City Hospital
Arms of the Study
Arm 1
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.