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 range30 Years – 68 Years
SexALL
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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…