Long Term Follow-up Grafted Huntington's Disease Patients

NCT ID: NCT06194006

Last Updated: 2024-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2034-01-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Huntington Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long term follow-up

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

Group Type OTHER

Follow-up

Intervention Type OTHER

Follow-up grafted patients as long as their condition allows

Interventions

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Follow-up

Follow-up grafted patients as long as their condition allows

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Catherine BACHOUD-LEVI, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, , France

Site Status

Countries

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France

Central Contacts

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Anne-Catherine BACHOUD-LEVI, MD, PhD

Role: CONTACT

1 49 81 43 01 ext. +33

Other Identifiers

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2018-A02569-46

Identifier Type: OTHER

Identifier Source: secondary_id

K140601J

Identifier Type: -

Identifier Source: org_study_id

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