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Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02683629
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Statistecol Consultants Limited
Information provided by (Responsible Party):
Living Cell Technologies

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 efficacy of xenotransplantation 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).


Condition or disease Intervention/treatment Phase
Parkinson's Disease Biological: NTCELL Implantation Other: Sham Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease
Actual Study Start Date : February 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NTCELL
NTCELL Implantation
Biological: NTCELL Implantation
NTCELL Implantation

Sham Comparator: Sham Surgery
Sham Surgery
Other: Sham Surgery
Sham Surgery




Primary Outcome Measures :
  1. The safety of xenotransplantation of NTCELL as measured by the incidence of adverse events related to treatment [ Time Frame: up to 26 weeks ]
    Adverse events can result from, for example, abnormal clinical laboratory tests (including xenogeneic viral analysis), abnormal physical examination findings, any abnormal findings following review by an infectious disease physician. These multiple assessments result in the one outcome measure which is the incidence of treatment emergent adverse events


Secondary Outcome Measures :
  1. Change in total Unified Parkinson's Disease Rating Scale (UPDRS in the 'off' and 'on' state) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III in the 'on' state) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  3. Change in Quality of life as assessed by Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  4. Change in L-dopa dosage over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  5. Change in 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-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  6. Change in scores measured by the modified walking test in accordance with the CAPSIT-PD protocol (Defer et al. 1999) over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]
  7. Change in Modified Hoehn and Yahr stage over 26 weeks post-intervention compared with baseline [ Time Frame: Baseline and 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Investigator
  6. If female, no childbearing capability (those who are more than 2 years post-menopausal or have undergone voluntary sterilisation can be considered for enrolment)
  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 μmol/L in men and > 110 μmol/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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683629


Locations
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New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
Living Cell Technologies
Statistecol Consultants Limited
Investigators
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Principal Investigator: Barry Snow Auckland City Hospital
Additional Information:
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Responsible Party: Living Cell Technologies
ClinicalTrials.gov Identifier: NCT02683629    
Other Study ID Numbers: LCT/PD-015
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: International conference presentations, press releases, International journal publications
Keywords provided by Living Cell Technologies:
Parkinson's Disease
Xenotransplantation
choroid plexus
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases