Status:
COMPLETED
MIG-HD: Multicentric Intracerebral Grafting in Huntington's Disease
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Huntington Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 Huntington's disease. The duration of the study wi...
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 Huntington's patient at early stage by homol...
Eligibility Criteria
Inclusion
- Disease clinically declared since at least 1 year ,UHDRS motor \> or =5
- TFC \> or = 10.
- CAG \> or = 36
- Age between 18 and 65
- Family and socially integrated subject
- Informed consent.
Exclusion
- Severe intellectual deterioration or neuropsychiatric disorders making the follow-up longitudinal too complicated (score MATTIS \< 120).
- Not-observance of the appointments and the symptomatic treatments in pre-surgical period.
- Intercurrent disease making a surgical operation impossible.
- Associated disease having a neurological repercussion, intercurrent cerebral lesion with the IRM.
- Visceral affection engraves, evolutionary, which brings into play the vital forecast or makes risks for general anaesthesia.
- Mental Affection likely to disturb adhesion with the protocol, and in particular antecedents of hallucinations spontaneous and/or induced by the drugs; antecedents of serious depression having required repeated hospitalizations; antecedents of repeated suicide attempts.
- Cerebral morphological anomalies, others that those characteristic of the disease, noted with the IRM or the tomodensitometry.
- Participation in progress, or stopped since less than three months, with a therapeutic protocol of the Huntington's disease Exclusion Criteria (pre-randomization)
- TFC \< 8
- Not-observance of the appointments and the symptomatic treatments in pre-surgical period.
- Intercurrent disease returning the surgery or impossible immunosuppression. v Subject completely isolated with his family and socially..
- UHDRS motor \< 5.
- Positives serologies for HIV1, HIV2, AgP24, HTLV1 et 2, HEPATITE B, HEPATITE C, syphilis
- Psychiatric disorders being able to compromise the follow-up.
- Signs other than Huntington with the IRM.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00190450
Start Date
January 1 2002
End Date
December 1 2013
Last Update
October 13 2017
Active Locations (1)
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1
Hopital Henri Mondor
Paris, Île-de-France Region, France, 94000