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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02569-46 | Other Identifier | IDRCB |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long term follow-up | Other |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up | Other | Follow-up grafted patients as long as their condition allows |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression of the Unified Huntington's Disease Rating Scale (UHDRS) motor score | For each patient | 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 | From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Catherine BACHOUD-LEVI, MD, PhD | Contact | 1 49 81 43 01 | +33 | anne-catherine.bachoud-levi@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Catherine BACHOUD-LEVI, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor | Créteil | 94010 | France |
DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 | 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 | 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 | For each patient | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From the end of participation at MIGHD's study until the death from any cause or assessed up to 10 years after consentement signed |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |