MIG-HD: Multicentric Intracerebral Grafting in Huntington's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190450
First received: September 15, 2005
Last updated: July 27, 2012
Last verified: March 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric Intracerebral Grafting in Huntington's Disease

Resource links provided by NLM:


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 [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    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: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: graft intracerebral of foetal neurons
graft intracerebral of foetal neurons
Other Name: graft intracerebral of foetal neurons

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, HEPATITE B, HEPATITE 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

Contacts
Contact: A-C. BACHOUD-LEVI, MD, PhD +33(0)-1 49814301 bachoud@lscp.ehess.fr

Locations
France
Hopital Henri Mondor Recruiting
Paris, Ile de France, France, 94000
Contact: A-C. BACHOUD-LEVI, MD,PhD    +33(0)-1 49 81 43 01    bachoud@lscp.ehess.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: A-C. BACHOUD-LEVI, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190450     History of Changes
Other Study ID Numbers: P 001106
Study First Received: September 15, 2005
Last Updated: July 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Huntington
graft
cellular therapy
striatum

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014