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TRANSEURO Open Label Transplant Study in Parkinson's Disease (TRANSEURO)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Lund University
Cardiff University
Imperial College London
University College, London
University Hospital Freiburg
Life Science Governance Institute
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Life Technologies Ltd, part of Thermo Fisher Scientific
Inomed
Cambridge Cognition Ltd
Skåne University Hospital
Imanova Limited
Information provided by (Responsible Party):
Prof Roger Barker, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01898390
First received: July 9, 2013
Last updated: May 10, 2016
Last verified: May 2016
  Purpose
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. Only 20 patients will be selected for the transplant.

Condition Intervention Phase
Parkinson's Disease
Procedure: Transplant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transplant
Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue
Procedure: Transplant
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 imaged using MRI.
    • Any contraindication to immunosuppression therapy.
    • Patients on anticoagulants
    • Patients who are left handed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898390

Sponsors and Collaborators
University of Cambridge
Lund University
Cardiff University
Imperial College London
University College, London
University Hospital Freiburg
Life Science Governance Institute
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Life Technologies Ltd, part of Thermo Fisher Scientific
Inomed
Cambridge Cognition Ltd
Skåne University Hospital
Imanova Limited
Investigators
Principal Investigator: Roger Barker, Prof Department of Clinical Neurosciences, University of Cambridge
  More Information

Responsible Party: Prof Roger Barker, Professor, University of Cambridge
ClinicalTrials.gov Identifier: NCT01898390     History of Changes
Other Study ID Numbers: TRANSEURO
FP7-242003 ( Other Grant/Funding Number: European Community Seventh Framework Programme )
Study First Received: July 9, 2013
Last Updated: May 10, 2016

Keywords provided by University of Cambridge:
Parkinson's Disease
Allo-Transplantation
Fetal Ventral Mesencephalic Tissue

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on March 24, 2017