Status:
COMPLETED
TRANSEURO Open Label Transplant Study in Parkinson's Disease
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Lund University
Cardiff University
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-68 years
Phase:
NA
Brief 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 t...
Detailed Description
Clinical trials of cell therapy in PD patients were first performed in Lund in the late 1980s, followed by a number of similar, small trials in other European and North American centres. These initial...
Eligibility Criteria
Inclusion
- 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
- 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 imaged using MRI.
- Any contraindication to immunosuppression therapy.
- Patients on anticoagulants
- Patients who are left handed
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01898390
Start Date
May 1 2012
End Date
December 31 2022
Last Update
May 25 2023
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