Clinical Trial Details
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NCT02683629 : Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease
PhasePhase 2
AgesMin: 40 Years Max: 65 Years
Inclusion Criteria:

1. Adults (males or females) in the age range 40 to 65 years

2. Diagnosis of Parkinson's disease (minimum duration of 5 years) in accordance with the
London Brain Bank criteria

3. Patients diagnosed with idiopathic Parkinson's disease

4. Optimum medication for Parkinson's disease

5. Expected to meet the criteria for DBS in the future, in the opinion of the

6. If female, no childbearing capability (those who are more than 2 years
post-menopausal or have undergone voluntary sterilisation can be considered for

7. 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:

1. Any history of central nervous system infection

2. Significant dementia as determined by neuropsychiatric assessment

3. Focal neurological defects

4. Evidence of significant ongoing medical or psychiatric disorders

5. Secondary parkinsonism

6. Severe autonomic symptoms

7. Atypical Parkinson's disease

8. History of substance abuse

9. Body mass index (BMI) ? 30 kg/m2 or ? 20 kg/m2

10. Serious comorbid conditions that, in the opinion of the Investigator, are likely to
affect participation in the study, including:

1. 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

2. Previous cerebrovascular disease manifesting as transient ischaemic attacks
(TIAs) or stroke

3. Peripheral vascular disease with foot ulcer and/or previous amputation

4. History of New York Heart Association (NYHA) class II, III or IV congestive
heart failure (CHF) and/or chronic atrial fibrillation

5. 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

6. 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

7. Haematological disorders, including haemoglobin ? 110 g/L or platelet count < 80
x 109/L

8. 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

9. Peptic ulcer disease and/or history of previous gastrointestinal bleeding

10. Malignancy other than basal cell carcinoma

11. History of epilepsy

12. Untreated hypothyroidism

13. Known adrenal insufficiency

11. Previous brain surgery for Parkinson's disease

12. Poor candidate for any surgery

13. HIV antibody and/or risk factors for HIV infection

14. Positive hepatitis C antibody, positive hepatitis B surface antigen, and hepatitis B
core antibody

15. Current administration of immunosuppressive medications (e.g. cyclosporin,
tacrolimus, sirolimus, mycophenolate mofetil, muromonab-CD3, daclizumab, basiliximab,
antithymocyte globulin, interferons) for other disease conditions

16. Any other condition that, in the opinion of the Investigator, may interfere with
adherence to the study protocol
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