Parkinson's DiseasePhase 1/2NCT01734733
Open-label Investigation of the Safety and Clinical Effects of NTCELL in Patients With Parkinson's Disease
A Phase 1/2 study testing NTCELL in people with Parkinson's Disease, run by Living Cell Technologies at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- NTCELL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNew Zealand
- Study dates
- 12 Jul 2013to 4 Jun 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 33Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
Read the detailed description
Parkinson's disease is characterized by widespread neural degeneration, particularly in the substantia nigra and its projections to the basal ganglia. Current therapy for Parkinson's disease is purely symptomatic. There is a pressing need for a treatment that reverses or slows the degeneration of the nigrostriatal pathway.
Numerous transplant-based therapies have attempted to support, repair or replace the degenerating nigrostriatal neurons. These have included the transplantation of foetal and other neuronal stem cells, gene transfers, and the implantation of devices releasing neural growth factors. All these have been shown to have some effectiveness in animal models, but have been generally disappointing in human studies.
Intracranial choroid plexus cell transplantation has the potential to deliver biological neural agents for the treatment of Parkinson's disease which cannot be achieved by conventional treatment. The overall aim of delivering neural proteins and compounds over many months to the basal ganglia of the brain is to enhance neural repair currently not possible with antiparkinsonian medication or deep brain stimulation (DBS).
As animal-derived tissues have to be protected from immune rejection when transplanted into humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine choroid plexus cells are preferably implanted without the use of immunosuppressive drugs which cause significant morbidity. To protect them from immune rejection, the cells can be encapsulated in alginate microcapsules which permit the inward passage of nutrients and the outward passage of biologic neural proteins and compounds normally secreted by choroid plexus cells. Alginate-encapsulated porcine choroid plexus cells implanted into the brain without immunosuppressive drugs have survived rejection for many months in animal studies.
NTCELL comprises neonatal porcine choroid plexus cells encapsulated in alginate microcapsules. NTCELL has been safely implanted in rats, and non-human primates. Following NTCELL implants, animals with chemically-induced Parkinson's-like lesions showed improvement of functional neurological motor abnormalities that was associated with histologic changes consistent with amelioration of the lesion.
The initial dose for intracranial implantation of the current NTCELL preparation for the treatment of Parkinson's disease in humans is based on the effective dose in a non-human primate (rhesus monkey) model.
Parkinson's disease patients will be followed up for 26 weeks after receiving an implantation of NTCELL administered into the putamen of the corpus striatum on the side contralateral to the greatest clinical deficit.
Based upon the data obtained during the 26-week follow-up period a decision will be made as to whether the patient will receive:
- an implantation of a second dose of NTCELL
- unilateral DBS
- bilateral DBS
- no further intervention
The data will be reviewed by the investigators and the Data Safety Monitoring Board (DSMB), the data will consist of clinical outcomes and clinimetric data, an MRI scan, PET scanning, and adverse events.
Patients will be followed up for a further 48 weeks if there is no further intervention, however if it is decided that either DBS or implantation of a second dose of NTCELL occurs then the frequency of follow-up will be the subject of a protocol amendment.
- Conditions
- Parkinson's Disease
- Being tested
- NTCELL
- Keywords
- Parkinson's Disease, Xenotransplantation, choroid plexus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTCELLOther
| Study group | Role | What they receive |
|---|---|---|
| NTCELL | Experimental | 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. Receives: Other: NTCELL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety of xenotransplantation of NTCELL
measured by the incidence of adverse events, clinical laboratory tests (including xenogeneic viral analysis), physical examination, review by infectious disease physician
Measured: 26 weeks
Secondary outcomes (10)
Brain metabolism as demonstrated on PET with [18F]-fluorodopa measured at 26 weeks post-implant 1 compared with baseline
Measured: 26 weeks
Brain metabolism as demonstrated on PET with [11C]-tetrabenazine measured at 26 weeks post-implant 1 compared with baseline
Measured: 26 weeks
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
Measured: 26 weeks
Modified Hoehn and Yahr stages over 26 weeks post-implant 1 compared with the baseline stages
Measured: 26 weeks
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
Measured: 26 weeks
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
Measured: 26 weeks
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
Measured: 26 weeks
Scores measured by the Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-implant 1 compared with the baseline scores
Measured: 26 weeks
Scores measured by neuropsychological tests at 26 weeks post-implant 1 compared with the baseline scores
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
Measured: 26 weeks
Psychiatric assessment at 26 weeks post-implant 1 compared with the baseline psychiatric assessment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study start12 Jul 2013
- Primary completion4 Jun 2015
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Living Cell Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry Snow, MBChB, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734733
- Sponsor's protocol ID
- LCT/PD-012
- Status last verified
- Jun 2020
- First submitted
- 18 Nov 2012
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01734733
- Acronym / sponsor ID
- LCT/PD-012
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Xenotransplantation, choroid plexus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Living Cell TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2013 (actual)
- Primary completion
- 4 Jun 2015 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Parkinson's disease is characterized by widespread neural degeneration, particularly in the substantia nigra and its projections to the basal ganglia. Current therapy for Parkinson's disease is purely symptomatic. There is a pressing need for a treatment that reverses or slows the degeneration of the nigrostriatal pathway.
Numerous transplant-based therapies have attempted to support, repair or replace the degenerating nigrostriatal neurons. These have included the transplantation of foetal and other neuronal stem cells, gene transfers, and the implantation of devices releasing neural growth factors. All these have been shown to have some effectiveness in animal models, but have been generally disappointing in human studies.
Intracranial choroid plexus cell transplantation has the potential to deliver biological neural agents for the treatment of Parkinson's disease which cannot be achieved by conventional treatment. The overall aim of delivering neural proteins and compounds over many months to the basal ganglia of the brain is to enhance neural repair currently not possible with antiparkinsonian medication or deep brain stimulation (DBS).
As animal-derived tissues have to be protected from immune rejection when transplanted into humans, transplants are usually accompanied by immunosuppressive therapy. However, porcine choroid plexus cells are preferably implanted without the use of immunosuppressive drugs which cause significant morbidity. To protect them from immune rejection, the cells can be encapsulated in alginate microcapsules which permit the inward passage of nutrients and the outward passage of biologic neural proteins and compounds normally secreted by choroid plexus cells. Alginate-encapsulated porcine choroid plexus cells implanted into the brain without immunosuppressive drugs have survived rejection for many months in animal studies.
NTCELL comprises neonatal porcine choroid plexus cells encapsulated in alginate microcapsules. NTCELL has been safely implanted in rats, and non-human primates. Following NTCELL implants, animals with chemically-induced Parkinson's-like lesions showed improvement of functional neurological motor abnormalities that was associated with histologic changes consistent with amelioration of the lesion.
The initial dose for intracranial implantation of the current NTCELL preparation for the treatment of Parkinson's disease in humans is based on the effective dose in a non-human primate (rhesus monkey) model.
Parkinson's disease patients will be followed up for 26 weeks after receiving an implantation of NTCELL administered into the putamen of the corpus striatum on the side contralateral to the greatest clinical deficit.
Based upon the data obtained during the 26-week follow-up period a decision will be made as to whether the patient will receive:
- an implantation of a second dose of NTCELL
- unilateral DBS
- bilateral DBS
- no further intervention
The data will be reviewed by the investigators and the Data Safety Monitoring Board (DSMB), the data will consist of clinical outcomes and clinimetric data, an MRI scan, PET scanning, and adverse events.
Patients will be followed up for a further 48 weeks if there is no further intervention, however if it is decided that either DBS or implantation of a second dose of NTCELL occurs then the frequency of follow-up will be the subject of a protocol amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NTCELL | Experimental | Other: NTCELLNTCELL 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTCELL | Other | NTCELL |
Primary outcome
the safety of xenotransplantation of NTCELL
Time frame: 26 weeks
measured by the incidence of adverse events, clinical laboratory tests (including xenogeneic viral analysis), physical examination, review by infectious disease physician
10 secondary outcomes
Brain metabolism as demonstrated on PET with [18F]-fluorodopa measured at 26 weeks post-implant 1 compared with baseline
Time frame: 26 weeks
Brain metabolism as demonstrated on PET with [11C]-tetrabenazine measured at 26 weeks post-implant 1 compared with baseline
Time frame: 26 weeks
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
Time frame: 26 weeks
Modified Hoehn and Yahr stages over 26 weeks post-implant 1 compared with the baseline stages
Time frame: 26 weeks
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
Time frame: 26 weeks
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
Time frame: 26 weeks
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
Time frame: 26 weeks
Scores measured by the Parkinson's Disease Questionnaire (PDQ-39) over 26 weeks post-implant 1 compared with the baseline scores
Time frame: 26 weeks
Scores measured by neuropsychological tests at 26 weeks post-implant 1 compared with the baseline scores
Time frame: 26 weeks
Psychiatric assessment at 26 weeks post-implant 1 compared with the baseline psychiatric assessment
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Snow, MBChB principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NTCELL in people with Parkinson's Disease, run by Living Cell Technologies at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safety of xenotransplantation of NTCELL (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.