Safety and feasibility of neural transplantation in early to moderate Huntington's disease in the UK
| ISRCTN | ISRCTN36485475 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36485475 |
| Secondary identifying numbers | G9825903 and 071659 |
- Submission date
- 23/10/2000
- Registration date
- 23/10/2000
- Last edited
- 27/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Steve Dunnett
Scientific
Scientific
The Brain Repair Group
Biomedical Science Building
Cardiff University
Museum Avenue
PO Box 911
Cardiff
CF10 3US
United Kingdom
| Phone | +44 (0)29 2087 5188 |
|---|---|
| dunnett@cf.ac.uk |
Study information
| Study design | Multicentre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Safety and feasibility of neural transplantation in early to moderate Huntington's disease in the UK |
| Study objectives | To determine the safety, feasibility and efficacy of foetal tissue transplantation as a restorative therapy for Huntington's disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neuroscience, psychiatry |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 01/10/1999 |
| Completion date | 30/06/2008 |
| Reason abandoned (if study stopped) | 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 10 patients and 10 controls from a larger cohort of approx. 60 |
| Total final enrolment | 17 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
The Brain Repair Group
Cardiff
CF10 3US
United Kingdom
CF10 3US
United Kingdom
Sponsor information
Medical Research Council (UK)
University/education
University/education
20 Park Crescent
London
W1B 1AL
England
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 071659)
No information available
Medical Research Council (UK) (grant ref: G9825903)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2002 | Yes | No | |
| Results article | results | 01/06/2013 | Yes | No | |
| Results article | results | 01/12/2018 | 27/08/2019 | Yes | No |
Editorial Notes
27/08/2019: Publication reference and total final enrolment added.
