NCT00190450

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

11.9 years

First QC Date

September 15, 2005

Last Update Submit

October 12, 2017

Conditions

Huntington Disease

Keywords

Huntingtongraftcellular therapystriatum

Outcome Measures

Primary Outcomes (1)

  • Motor UHDRS rating scale, at randomization, 20 month after transplant

    during de study

Secondary Outcomes (1)

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

    during the study

Study Arms (2)

1

EXPERIMENTAL

Early Graft (Early G)

Biological: graft intracerebral of foetal neurons

2

EXPERIMENTAL

Late Graft (Late G)

Biological: graft intracerebral of foetal neurons

Interventions

graft intracerebral of foetal neuronsBIOLOGICAL

graft intracerebral of foetal neurons

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Henri Mondor

Paris, Île-de-France Region, 94000, France

Location

Related Publications (6)

  • 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. doi: 10.1016/s0140-6736(00)03310-9.

    PMID: 11130527RESULT

  • Kinfe T, Del Vecchio A, Nussel M, Zhao Y, Stadlbauer A, Buchfelder M. Deep brain stimulation and stereotactic-assisted brain graft injection targeting fronto-striatal circuits for Huntington's disease: an update. Expert Rev Neurother. 2022 Sep;22(9):781-788. doi: 10.1080/14737175.2022.2091988. Epub 2022 Jun 29.

    PMID: 35766355DERIVED

  • Riad R, Lunven M, Titeux H, Cao XN, Hamet Bagnou J, Lemoine L, Montillot J, Sliwinski A, Youssov K, Cleret de Langavant L, Dupoux E, Bachoud-Levi AC. Predicting clinical scores in Huntington's disease: a lightweight speech test. J Neurol. 2022 Sep;269(9):5008-5021. doi: 10.1007/s00415-022-11148-1. Epub 2022 May 14.

    PMID: 35567614DERIVED

  • Bachoud-Levi AC; on behalf the Multicentric Intracerebral Grafting in Huntington's Disease Group. Human Fetal Cell Therapy in Huntington's Disease: A Randomized, Multicenter, Phase II Trial. Mov Disord. 2020 Aug;35(8):1323-1335. doi: 10.1002/mds.28201. Epub 2020 Jul 15.

    PMID: 32666599DERIVED

  • Schramm C, Katsahian S, Youssov K, Demonet JF, Krystkowiak P, Supiot F, Verny C, Cleret de Langavant L, Bachoud-Levi AC; European Huntington's Disease Initiative Study Group and the Multicentre Intracerebral Grafting in Huntington's Disease Group. How to Capitalize on the Retest Effect in Future Trials on Huntington's Disease. PLoS One. 2015 Dec 29;10(12):e0145842. doi: 10.1371/journal.pone.0145842. eCollection 2015.

    PMID: 26714284DERIVED

  • Teichmann M, Gaura V, Demonet JF, Supiot F, Delliaux M, Verny C, Renou P, Remy P, Bachoud-Levi AC. Language processing within the striatum: evidence from a PET correlation study in Huntington's disease. Brain. 2008 Apr;131(Pt 4):1046-56. doi: 10.1093/brain/awn036. Epub 2008 Mar 11.

    PMID: 18334537DERIVED

Related Links

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • A-C. BACHOUD-LEVI, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 19, 2005

Study Start

January 1, 2002

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

FR(1)