Long Term Follow-up Grafted Huntington's Disease Patients (Post-MIGHD)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Huntington Disease

Treatments: Other: Follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT06194006

2018-A02569-46 (Other Identifier)

K140601J

Details and patient eligibility

About

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.

Full 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

Enrollment: 39 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Long term follow-up

Other group

Description:

* Formalized and standardized follow-up * Retrospective data collection * Biological collections * Biological collections's centralisation

Treatment:

Other: Follow-up