Huntington Disease Clinical Trial
Official title:
Multicentric Intracerebral Grafting in Huntington's Disease
The aim of this study is to assess the clinical benefit of intrastriatal grafting of human cells from the foetal ganglionic eminence in patients with Huntington's disease. The duration of the study will be 52 months. A first group of patients will be grafted at M13-14 (early G group) and a second group of patients will be grafted at M33-34 (late G group). The principal criterion is the comparison of the progression between M12 and M32 of the motor score (TMS) of the UHDRS between grafted patients (early G group) and not yet grafted patients (late G group). An additional evaluation will be performed to compare the progression in individual patients over the 52-month study period. We will thus be able to compare the pre and post-graft TMS progression for all patients.
The aim of this study is to show the existence of a clinical benefit rising from a
substitution of the striatal neurons degenerated among a large cohort of Huntington's patient
at early stage by homologous neurons coming from human foetuses, This effect will be
estimated, compared with a group of patients not treated at first, on the results of the
motor scale of the Unified Huntington Disease Rating Scale (UHDRS, Huntington study group, on
1996).
Transplants will be realized in two surgical times to avoid the risk of hurts per-operating,
BI-CAUDES, if transplants were realized at single time. The minimal interval between both
transplants will be of 2 weeks, so as to let the patient recover of the first general
anaesthesia It's a multicentric study of phase II randomised and controlled, with direct
individual benefit.
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