Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients

NCT ID: NCT02084407

Last Updated: 2014-09-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

Brief Summary

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The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem cells in order to study the cardiac alterations induced by CTG expansions.

Detailed Description

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Conditions

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DM1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DM1 subject with cardiopathy

Clinical examination, Skin biopsy, Blood and urine sampling

Group Type ACTIVE_COMPARATOR

Clinical examination, skin biopsy, blood and urine sampling

Intervention Type OTHER

DM1 subject without cardiopathy

Clinical examination, Skin biopsy, Blood and urine sampling

Group Type ACTIVE_COMPARATOR

Clinical examination, skin biopsy, blood and urine sampling

Intervention Type OTHER

Not DM1subject

Clinical examination, Skin biopsy, Blood and urine sampling

Group Type ACTIVE_COMPARATOR

Clinical examination, skin biopsy, blood and urine sampling

Intervention Type OTHER

Interventions

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Clinical examination, skin biopsy, blood and urine sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged 20-50
* DM1 confirmed by molecular analysis
* Confirmed cardiomyopathy (infrahissiens conduction disorders)
* able to sign the consent form
* affiliated to european social security.


* aged 20-50
* DM1 confirmed by molecular analysis
* No cardiomyopathy (no infrahissiens conduction disorders or other trouble linked to DM1)
* able to sign the consent form
* affiliated to european social security.


* aged over 18
* brother, sister, father or mother of the DM1 patient
* No DM1 confirmed by molecular analysis (CTG repetition under 38)
* No cardiac disorders.
* able to sign the consent form
* affiliated to european social security.

Exclusion Criteria

* no pragnant or nursing women
* patient unable to understand informed consent
* patient under juridic protection
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Myologie, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Servais, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Myology

Locations

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Institute of Myology

Paris, , France

Site Status

Countries

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France

Other Identifiers

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DM1-Fibroblasts

Identifier Type: -

Identifier Source: org_study_id

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