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| [ Print-friendly version ] |
| Safety and feasibility of neural transplantation in early to moderate Huntington's disease in the UK |
| ISRCTN | ISRCTN36485475 |
| DOI | 10.1186/ISRCTN36485475 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Safety and feasibility of neural transplantation in early to moderate Huntington's disease in the UK |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | G9825903 and 071659 |
| Study hypothesis | To determine the safety, feasibility and efficacy of foetal tissue transplantation as a restorative therapy for Huntington's disease |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Multicentre, randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Neuroscience, psychiatry |
| Participants - inclusion criteria |
1. Genetically confirmed Huntington's disease
2. Early to moderate stage of disease 3. Presence of motor signs 4. Availability of one close primary informant |
| Participants - exclusion criteria |
1. Advanced disease
2. Still employable in usual occupation 3. Other concurrent major illness 4. Current serious psychiatric disturbance 5. Inadequate social support 6. Below the age of 18 |
| Anticipated start date | 01/10/1999 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 10 patients and 10 controls from a larger cohort of approx. 60 |
| Interventions |
Patients in matched pairs randomly allocated to experimental and control conditions; the pairs are selected from a larger research cohort undergoing longitudinal assessment but not (yet) selected for participation in the surgical trial.
All subjects will be examined using Positron Emission Tomography (PET) to assess survival and functional integration of the implanted grafts. The imaging component of the study, entitled 'Pre- and post-operative PET studies of Huntington's disease patients receiving human fetal striatal cell implants' (RTF - 071659), is funded by Wellcome trust, as part of the research training fellowship (for Y F Tai). As of September 2007, this trial is still open, but temporarily suspended following introduction of EU Tissue directive and pending upgrading of facilities to GMP compliance and MHRA accreditation. The end date of the follow up period will be extended to two years after thelast patient was operated on. Please also note that as of 22nd January 2007 the Sponsor institution of this trial changed. The previous sponsor was: Cardiff University (UK) Cardiff CF10 3XQ United Kingdom +44 (0)29 2087 4000 Http://www.cardiff.ac.uk |
| Primary outcome measure(s) |
Safety trial:
1. Presence/absence of adverse events 2. Feasibility: a. co-ordination of an effective and efficient programme for foetal tissue collection b. biosafety assessment c. preparation and implantation into identified patients and their long term evaluation on the relevant structural and functional criteria of graft survival and efficacy Efficacy trial: Retardation or reversal of the progress of the disease in the affected patients as determined by the neurological, neuropsychological and neuropsychiatric and imaging criteria of neuropsychological tests of cognition using the CAmbridge Neuropsychological Test Automated Battery (CANTAB) test battery. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding |
1. The Wellcome Trust (UK) (grant ref: 071659)
2. Medical Research Council (UK) (grant ref: G9825903) |
| Trial website | |
| Publications |
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12438470
2. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23345280 |
| Contact name | Prof Steve Dunnett |
| Address |
The Brain Repair Group
Biomedical Science Building Cardiff University Museum Avenue PO Box 911 |
| City/town | Cardiff |
| Zip/Postcode | CF10 3US |
| Country | United Kingdom |
| Tel | +44 (0)29 2087 5188 |
| Fax | +44 (0)29 2087 6749 |
| dunnett@cf.ac.uk | |
| Sponsor | Medical Research Council (UK) |
| Address | 20 Park Crescent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Tel | +44 (0)20 7636 5422 |
| Fax | +44 (0)20 7436 6179 |
| clinical.trial@headoffice.mrc.ac.uk | |
| Sponsor website: | http://www.mrc.ac.uk |
| Date applied | 23/10/2000 |
| Last edited | 28/01/2013 |
| Date ISRCTN assigned | 23/10/2000 |
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| © 2013 ISRCTN unless otherwise stated. | |
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