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NCT Number: NCT06194006

Long Term Follow-up Grafted Huntington's Disease Patients

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, 94010, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up

Other

Follow-up grafted patients as long as their condition allows

Primary outcomes

  1. 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

    For each patient

  2. 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

    For each patient

Secondary outcomes

  1. 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

    For each patient

  2. 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

    For each patient

  3. 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

    For each patient

  4. 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

    For each patient

  5. 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

    Grafted patients and cohort patients (BIOHD)

  6. 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

    For each patient

  7. 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

    For each patient

  8. 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

    For each patient

  9. 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

    For each patient

  10. 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

    For each patient

  11. 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

    For all patients whose brains have been recovered

  12. 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

    For each patient

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Catherine BACHOUD-LEVI, MD, PhD

CONTACT

[email protected]

1 49 81 43 01 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Post-MIGHD

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Jan 8, 2024
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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