Condition category
Mental and Behavioural Disorders
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
28/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Steve Dunnett

ORCID ID

Contact details

The Brain Repair Group
Biomedical Science Building
Cardiff University
Museum Avenue
PO Box 911
Cardiff
CF10 3US
United Kingdom
+44 (0)29 2087 5188
dunnett@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9825903 and 071659

Study information

Scientific title

Acronym

Study hypothesis

To determine the safety, feasibility and efficacy of foetal tissue transplantation as a restorative therapy for Huntington's disease

Ethics approval

Not provided at time of registration

Study design

Multicentre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/1999

Overall trial end date

30/06/2008

Reason abandoned

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 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10 patients and 10 controls from a larger cohort of approx. 60

Participant 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

Recruitment start date

01/10/1999

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Brain Repair Group
Cardiff
CF10 3US
United Kingdom

Sponsor information

Organisation

Medical Research Council (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

University/education

Website

http://www.mrc.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 071659)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (UK) (grant ref: G9825903)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12438470
2. 2013 results in www.ncbi.nlm.nih.gov/pubmed/23345280

Publication citations

  1. Results

    Rosser AE, Barker RA, Harrower T, Watts C, Farrington M, Ho AK, Burnstein RM, Menon DK, Gillard JH, Pickard J, Dunnett SB, , Unilateral transplantation of human primary fetal tissue in four patients with Huntington's disease: NEST-UK safety report ISRCTN no 36485475., J. Neurol. Neurosurg. Psychiatr., 2002, 73, 6, 678-685.

  2. Results

    Barker RA, Mason SL, Harrower TP, Swain RA, Ho AK, Sahakian BJ, Mathur R, Elneil S, Thornton S, Hurrelbrink C, Armstrong RJ, Tyers P, Smith E, Carpenter A, Piccini P, Tai YF, Brooks DJ, Pavese N, Watts C, Pickard JD, Rosser AE, Dunnett SB, , The long-term safety and efficacy of bilateral transplantation of human fetal striatal tissue in patients with mild to moderate Huntington's disease., J. Neurol. Neurosurg. Psychiatr., 2013, 84, 6, 657-665, doi: 10.1136/jnnp-2012-302441.

Additional files

Editorial Notes