TRANSEURO Open Label Transplant Study in Parkinson's Disease

NCT01898390 | Completed DMC

• 2 other identifiers: TRANSEUROFP7-242003
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Allo-Transplantation; Fetal Ventral Mesencephalic Tissue

Outcome Measures

Primary Outcomes (1)

• Change in UPDRS score

  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).

  36 months post transplantation

Secondary Outcomes (7)

• Change in timed motor tasks

  36 months post transplantation

• Number of dyskinesias at 36 months

  36 months post transplantation

• L-dopa equivalent medication at 36 months

  36 months post transplantation

• L-dopa therapy at 36 months

  36 months post transplant

• Off time medication at 36 months

  36 months post transplantation

Other Outcomes (3)

• AE/SAE's

  0-36 months post treatment

• Laboratory Parameters

  0-36 months post treatment

• Other Safety parameters

  0-36 months post treatment

Study Arms (2)

Transplant

EXPERIMENTAL

Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue

Procedure: Transplant

Control

NO INTERVENTION

comparison group of controls, will receive the same observational and scanning assessments but will not receive any surgical procedures

Interventions

Transplant PROCEDURE

Bilateral Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue

Transplant

Eligibility Criteria

• Age: 30 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead
• Lund University: collaborator
• Cardiff University: collaborator
• Imperial College London: collaborator
• University College, London: collaborator
• University Hospital Freiburg: collaborator
• Life Science Governance Institute: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Life Technologies Ltd, part of Thermo Fisher Scientific: collaborator
• Inomed: collaborator
• Cambridge Cognition Ltd: collaborator
• Skane University Hospital: collaborator
• Imanova Limited: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Roger Barker, Prof

  Department of Clinical Neurosciences, University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: May 1, 2012
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 25, 2023

Record last verified: 2023-05