Chief Investigator: Roger Barker
TRANSEURO is a large multicentre European research project with the aim of assessing the safety and tolerability of human fetal-cell transplantation for the treatment of Parkinson’s disease. The TRANSEURO working group was originally established in 2006 with funding from Parkinson’s UK. The clinical component of the TRANSEURO study includes 2 arms: an experimental cell-transplantion trial and an observational study.
Previously trials of neural fetal ventral mesencephalic tissue implantation for the treatment of Parkinson’s disease had shown mixed results. It was also thought that a particular side effect of this therapy (graft-induced dyskinesias) occurred due to an issue which could be controlled more appropriately than was possible during the original trials.
Therefore, In 2010, with funding from European Commission, recruitment of a medium-sized cohort of patients with early-stage, mild-moderate Parkinson’s disease began. In total, 153 individuals across 7 sites joined an observational ‘run-in’ study in which they were assessed bi-annually with motor, cognitive and psychiatric assessments for at least 36 months. A subset of patients which remained eligible for the experimental therapy entered a randomisation process. Patients that were not randomised to receive the treatment or not considered eligible, continued to be assessed bi-annually as part of the observational study and will act as a control group.
By March 2018, 11 patients had received a bilateral fetal-cell transplant. The same battery of assessments is used to assess these patients and the control group in bi-annual follow-up. This has been funded by Cure Parkinson’s Trust, Medical Research Council, JBFC in the UK and MultiPark in Sweden. Neurosurgeries were conducted at Addenbrooke’s Hospital, Cambridge and Lund Skåne University Hospital, Sweden.
Patients in the observational group (those that did not receive any experimental treatment) and patients that received the grafting of fetal tissue continue to be assessed bi-annually. We are closely monitoring the patients in the transplant group for any safety issues or adverse events associated with the treatment and will assess whether there is any signal of clinical benefit by comparing change UPDRS-motor scores at 3-years post-transplant. The observational study continues to collect important information about the natural progression of Parkinson’s disease in a subset of patients who are considered suitable for cell-based therapy trials. We hope that this data will be useful in the planning of the first human dopaminergic stem-cell based therapy trials in Parkinson’s disease.
As of 2019, there are 5 TRANSEURO centres; University of Cambridge, University College London, Imperial College London, Cardiff University, Lund Skane University. Recently, Prof Roger Barker published an article in Nature Medicine, on behalf of the TRANSEURO consortium, which summarised in detail the challenges encountered and lessons learned in TRANSEURO (see our publications page for more information).
For more information about transeuro you are welcome to contact the study coordinator, Sam Hewitt directly (email@example.com).
This trial is funded through the European Commission.
Azathioprine immunosuppression and disease modification in Parkinson’s disease (AZA-PD)
Chief Investigator: Caroline Williams-Gray
Sub Investigator: Julia Greenland
Immune activation is strongly implicated in a number of neurodegenerative diseases, including Parkinson’s disease. Our own work to date has demonstrated not only that there is a genetic link between the immune system and Parkinson’s risk, but also that there is a more active immune response in Parkinson’s patients compared to healthy controls, with raised inflammatory markers in the blood being associated with more rapid progression of the disease. This clinical trial will test whether suppressing the immune response in Parkinson’s disease patients with a drug called azathioprine has an impact on disease progression over 12 months of treatment. Azathioprine is a drug which is already widely used for a number of immune and inflammatory conditions, and so we are familiar with its safety profile. This means that we can rapidly ‘reposition’ azathioprine in a trial in Parkinson’s disease. If the trial has a positive outcome, it may pave the way for using immune-suppressing drugs to delay disability and prevent progression to the some of the most feared complications of Parkinson’s including loss of balance and dementia – for which we currently have no effective treatments.
Participants in the trial will be randomly allocated to take either azathioprine or placebo for 12 months. The response will be evaluated with a range of clinical measures. We will also evaluate the effect of azathioprine on markers of immune activation in blood and cerebrospinal fluid, and on inflammation in the brain measured with PET imaging. This trial is currently in the planning phase. We anticipate that recruitment will begin in late 2019.
This trial is funded by the Cambridge Centre for Parkinson’s Plus.
Chief Investigator: Roger Barker
Principal Investigator: Phil Buttery
OXB-102-01 is a clinical trial exploring the safety and tolerability of a gene therapy in patients with Parkinson’s disease. This is the second generation of the OXB drug, which was previously administered in the ProSavin ® study.
The rationale behind developing the drug is to provide a new therapy for patients who have been taking oral dopamine treatments long term and whose symptoms are no longer adequately controlled by these medications.
The drug is infused into the putamen of the brain during a surgical operation. The aim is that the gene will infect cells in the brain so that they can start producing their own dopamine. The therapy is a onetime treatment with the hope that the brain will continue to replace the dopamine in the long-term and allow patients to cut down their dopamine medications and improve their movement control.
The trial is being carried out across three sites; Cambridge, London and Paris. Two patients in the UK have now had the treatment and will undergo follow up for ten years to monitor any effects of the drug. We hope to administer the treatment to five more patients at the Cambridge site over the next 1-2 years.
If you would like to participate in one of the studies, or to have some more information about this research please contact Sam Hewitt on 01223 331160 or firstname.lastname@example.org
This trial is funded by Axovant.