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OpenTrials
Completed

NCT Number: NCT02084407

Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients

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.

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Key information

Conditions

DM1 Cardiovascular Diseases Heart Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Myology

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for DM1 patient with cardiomyopathy:

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

Inclusion criteria

for DM1 patient without cardiomyopathy

  • 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.

Inclusion criteria

for controls

  • 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

Treatment and study plan

Clinical examination, skin biopsy, blood and urine sampling

Other

Primary outcomes

  1. Measure of DM1 alterations in human cardiomyocytes derived from induced pluripotent stem cells

    Time frame: At baseline

Secondary outcomes

  1. Molecular changes in human DM1 cardiomyocytes expressing pathogenic CUGexp-RNA

    Time frame: At baseline

Sponsors and collaborators

Lead sponsor

Institut de Myologie, France

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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