Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190450
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2005-09-15
Brief Title:
MIG-HD Multicentric Intracerebral Grafting in Huntingtons Disease
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Multicentric Intracerebral Grafting in Huntingtons Disease
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIG-HD
Brief Summary:
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 Huntingtons 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
Detailed Description:
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 Huntingtons 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 Its a multicentric study of phase II randomised and controlled with direct individual benefit
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 Its a multicentric study of phase II randomised and controlled with direct individual benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None