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Not yet recruiting NCT06194006

Long Term Follow-up Grafted Huntington's Disease Patients

No phase Interventional Huntington Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow-up.
Who it may be relevant to
Registry conditions: Huntington Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Long-term Follow-up of Huntington's Disease Patients Treated With Intrastriatal Fetal Neuron Allograft

Overview

Long-term follow-up of Huntington's disease patients treated with intrastriatal allografts is essential to assess the benefit/risk ratio of grafts as well as their effectiveness. Indeed, some patients are likely to develop adverse effects and the impact of alloimmunisation phenomena remains to be explored.

Detailed description

The aim is to create a specific cohort of transplant patients, to homogenise their follow-up methods, to collect all the patient data (medical, paramedical, imaging, biological) acquired from the end of their participation in MIG-HD'study (Foetal Striatal allografting in Huntington's disease: a multicentre, randomised, delayed start, phase 2 open-label cell therapy trial) until the last possible follow-up of the last patient in the study

Interventions

  • Other Follow-up
    Follow-up grafted patients as long as their condition allows

Primary outcome measures

  • Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Progression of the Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP) motor score [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
Secondary outcome measures (12)
  • Slopes comparison of neurological scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Slopes comparison of cognitive scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Slopes comparison of psychiatric scores (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) before and after transplantation [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Slopes comparison of neuropsychologic scores (Mattis Dementia Rating Scale/Trail Making test/Hopkins Verbal Learning Test/Categorical fluency/Sign barrier test/Montgomery-Åsberg Depression Rating Scale (MADRS)) before and after transplantation [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Comparison of the clinical evolution (Unified Huntington's Disease Rating Scale (UHDRS) or Unified Huntington's Disease Rating Scale For Advanced Patients (UHDRS-FAP)) of transplanted patients with that of non-transplanted patients in the BioHD cohort [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Events and adverse reactions recording since the transplantation [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Research and identification of anti-MHC Ab from samples acquired under the MIG-HD and Post-MIGHD protocols as well as in care [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Correlation between graft activity measured by imaging and patient performance [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Correlation between post-mortem observations of the brains of deceased patients and measurements obtained by MRI and PET-SCAN in studies MIG-HD and BioHD [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Correlation between post-mortem brain observations and patient performance before death [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Analysis of brains collected as part of MIG-HD and POST-MIGHD i) to quantify neuropathological lesions ii) to search for markers of inflammatory reactions [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
  • Research into predictive factors (relationships between fetal haplotypes, patient haplotypes and appearance of alloimmunization phenomena) of the evolution of transplanted patients [Time frame: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]

Eligibility criteria

Inclusion criteria

  • Adult patients transplanted under the MIG-HD protocol
  • Information and informed consent from patients or their representative
  • Affiliation with a social security scheme or beneficiary

Exclusion criteria

  • Patient under AME
  • Patient unable to express consent and not subject to legal protection
  • Knowned pregnancy or breastfeeding woman

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor — Créteil

Identifiers

NCT: NCT06194006 · K140601J · 2018-A02569-46

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗