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Набор скоро начнётся NCT06194006

Long Term Follow-up Grafted Huntington's Disease Patients

Без фазы С лечением Huntington Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Follow-up.
Кому может быть актуально
Состояния в реестре: Huntington Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

  • Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score [Срок оценки: 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 [Срок оценки: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]
Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor — Créteil

Идентификаторы

NCT: NCT06194006 · K140601J · 2018-A02569-46

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗