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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
39
Follow-up grafted patients as long as their condition allows
Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, France
Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score
For each patient
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
For each patient
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 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
For each patient
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
For each patient
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
For each patient
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
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For each patient
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
Grafted patients and cohort patients (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
Events and adverse reactions recording since the transplantation
For each patient
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
For each patient
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
For each patient
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
For each patient
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
For each patient
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
For all patients whose brains have been recovered
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
For each patient
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