MIG-HD: Multicentric Intracerebral Grafting in Huntington's Disease
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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 |
- 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
- 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 |
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| Contact: A-C. BACHOUD-LEVI, MD, PhD | +33(0)-1 49814301 | bachoud@lscp.ehess.fr |
| 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 | |
| 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 June 17, 2013