MIG-HD: Multicentric Intracerebral Grafting in Huntington’s Disease - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190450

Purpose

The aim of this study is to show the existence of a clinical benefit rising from a substitution of the striatal neurons degenerated among patients reached of disease of Huntington by homologous neurons coming from human foetuses, by comparison of a treated group and a reference group not-treaty. The principal criterion is the progression of the motor score of the UHDRS by comparing the values obtained in the group treated by bilateral graft intrastriatal of foetal neurons with the values obtained in the group controls. At the end of this protocol, the patients controls will be grafted (with thus 18 months of time compared to the treated group). A secondary evaluation is envisaged 18 months after the graft of the group controls for the whole of the patients (either in 52 months). We will be able to thus compare the pre performances and 18 months post-graft for all 60 patients.

Condition	Intervention	Phase
Huntington Disease	Procedure: graft intracerebral of foetal neurons	Phase II

Genetics Home Reference related topics: chorea-acanthocytosis familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease Hurricanes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Multicentric Intracerebral Grafting in Huntington’s Disease

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Motor UHDRS rating scale, at randomization, 20 month after and at the end of the protocol

Secondary Outcome Measures:

Neurologic, Cognitive, Neurophysiologic, Psychiatric, MRI and Pet-scan evaluation at randomization, 20 month after and at the end of the protocol

Estimated Enrollment:	60
Study Start Date:	January 2002
Estimated Study Completion Date:	July 2009

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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, hépatite B, hépatite C, syphilis
Psychiatric disorders being able to compromise the follow-up.
Signs other than Huntington with the IRM.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190450

Locations

France, Ile De France
Hopital Henri Mondor
PARIS, Ile De France, France, 94000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

A-C. BACHOUD-LEVI, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

Huntington french speaking network website This link exits the ClinicalTrials.gov site

Publications of Results:

Bachoud-Levi AC, Remy P, Nguyen JP, Brugieres P, Lefaucheur JP, Bourdet C, Baudic S, Gaura V, Maison P, Haddad B, Boisse MF, Grandmougin T, Jeny R, Bartolomeo P, Dalla Barba G, Degos JD, Lisovoski F, Ergis AM, Pailhous E, Cesaro P, Hantraye P, Peschanski M. Motor and cognitive improvements in patients with Huntington's disease after neural transplantation. Lancet. 2000 Dec 9;356(9246):1975-9.

Publications indexed to this study:

Teichmann M, Gaura V, Démonet JF, Supiot F, Delliaux M, Verny C, Renou P, Remy P, Bachoud-Lévi AC. Language processing within the striatum: evidence from a PET correlation study in Huntington's disease. Brain. 2008 Apr;131(Pt 4):1046-56. Epub 2008 Mar 11.

Study ID Numbers:	P 001106, AOM 00139
Study First Received:	September 15, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00190450
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Huntington
graft
cellular therapy
striatum

Study placed in the following topic categories:

Ganglion Cysts
Huntington disease
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease
Delirium

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009