TRANSEURO Open Label Transplant Study in Parkinson's Disease (NCT01898390) | Clinical Trial Compass
CompletedNot Applicable
TRANSEURO Open Label Transplant Study in Parkinson's Disease
13 participantsStarted 2012-05
Plain-language summary
The Transeuro Transplant study is a trial which will involve grafting foetal tissue into the brain of patients with Parkinson's disease, who are already been followed in the observational study. The tissue inserted in the brain is to help replace and rebuild lost dopamine from the brain due to Parkinson's disease.
Update April 2019:
A total of 11 PD patients were grafted in Cambridge, UK and Lund, Sweden. No further surgeries are planned. The final patient will complete the study's clinical endpoint (36 months post-graft) in 2021. We continue to assess these patients bi-annually alongside a control group which did not receive any intervention.
Who can participate
Age range
30 Years – 68 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must meet ALL of the following criteria to be considered for the enrolment into this study:
* PD as defined using Queen's Square Brain Bank criteria.
* Disease duration ≥ 2 years and ≤ 13 years.
* Aged ≥ 30 years and ≤ 68 years at the time of grafting.
* Hoehn \& Yahr stage 2.5 or better when 'on'.
* On standard anti PD medication without significant LIDs defined as a score of \>2 on the AIMS dyskinesia rating scale, in any body part.
* Patients must be right handed.
Exclusion Criteria:
* Any of the following will exclude patients from being enrolled in the study:
* Atypical or secondary parkinsonism including F-DOPA PET patterns consistent with this.
* Clinically significant response to Levodopa (as evaluated by the clinician) and/or apomorphine challenge.
* Mini-Mental State Examination (MMSE) score of less than 26.
* Unable to do normal copying of interlocking pentagons and semantic fluency score for naming animals of less than 20 over 90 seconds as these have recently been associated with the earlier onset of dementia in PD.
* Ongoing major medical or psychiatric disorder including depression and psychosis.
* Other concomitant treatment with neuroleptics (inc. Atypical neuroleptics) and cholinesterase inhibitors.
* Significant drug induced dyskinesia defined as a score of \>2 on the AIMS dyskinesia rating scale, in any body part.
* Previous neurosurgery, cell therapy or organ transplantation.
* Unable to be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.