Clinical Trial Details
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NCT01734733 : Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease
PhasePhase 1/Phase 2
AgesMin: 40 Years Max: 70 Years
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,

- 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 ?mol/L in men and > 110 ?mol/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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