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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06194006
Other study ID # K140601J
Secondary ID 2018-A02569-46
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2034

Study information

Verified date May 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Anne-Catherine BACHOUD-LEVI, MD, PhD
Phone 1 49 81 43 01
Email anne-catherine.bachoud-levi@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date January 1, 2034
Est. primary completion date January 1, 2034
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor Créteil

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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