TRANSEURO Open Label Transplant Study in Parkinson's Disease (TRANSEURO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01898390|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : April 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Procedure: Transplant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study to Assess the Safety and Efficacy of Neural Allo-Transplantation With Fetal Ventral Mesencephalic Tissue in Patients With Parkinson's Disease|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue
Bilateral Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue
No Intervention: Control
comparison group of controls, will receive the same observational and scanning assessments but will not receive any surgical procedures
- UPDRS change [ Time Frame: 36 months post transplantation ]The change in motor Unified Parkinson's Disease Rating Scale (UPDRS)in a defined "OFF" state at 36 months post transplantation. "OFF" being defined as receiving no dopamine (DA) therapy for 12 hours prior to assessment or longer in the case of long acting dopamine agonists (e.g. Ropinirole slow release).
- Change in timed motor tasks [ Time Frame: 36 months post transplantation ]Change in timed motor tasks at 36 months post transplantation
- Dyskinesias [ Time Frame: 36 months post transplantation ]The number of patients with dyskinesias (including L-dopa and graft induced dyskinesias) at 36 months post transplantation
- L-dopa equivalent medication [ Time Frame: 36 months post transplantation ]L-dopa equivalent medication doses at 36 months post transplantation.
- L-dopa therapy [ Time Frame: 36 months post transplant ]Number of patients on L-dopa therapy at 36 months post transplantation.
- Off time [ Time Frame: 36 months post transplantation ]The amount of 'off' time 36 months post transplantation
- Quality of life [ Time Frame: 36 months post transplantation ]Quality of life (change) 36 months post transplantation
- F-DOPA PET changes [ Time Frame: 36 months post transplantation ]Changes in F-DOPA PET in transplanted patients 36 months post transplantation
- AE/SAE's [ Time Frame: 0-36 months post treatment ]The number of adverse events and serious adverse events associated with the neural transplant
- Laboratory Parameters [ Time Frame: 0-36 months post treatment ]Any reported changes in haematology, biochemistry or urinalysis measures outside the normal range
- Other Safety parameters [ Time Frame: 0-36 months post treatment ]Vital signs, Physical Exam - new abnormalities will be recorded as an adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898390
|Principal Investigator:||Roger Barker, Prof||Department of Clinical Neurosciences, University of Cambridge|