Long Term Follow-up Grafted Huntington's Disease Patients

Huntington Disease Clinical Trial

— Post-MIGHD  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Huntington Disease

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