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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01734356
Other study ID # BRD/10/11-P
Secondary ID
Status Terminated
Phase N/A
First received November 22, 2012
Last updated November 6, 2014
Start date November 2011
Est. completion date November 2014

Study information

Verified date November 2014
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France : Agence Française de Sécurité Sanitaire des Produits de Santé
Study type Interventional

Clinical Trial Summary

The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 22 Years to 60 Years
Eligibility Inclusion criteria:

- Patient with a family history of inherited arrhythmia or valvulopathy

- Age : 22-60 yo.

- patient no confine to bed

- Male or female

- Written consent

- Patient affiliated to the French social security

Exclusion criteria:

- Pregnant woman

- Patient under 22 yo or adults under guardianship

- Indication against local anesthesia

- Anticoagulant treatment

- Absence or positivity of HIV, HBV, HCV serology

Study Design

Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Skin biopsies


Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Production of cardiomyocytes modele from skin fibroblast of arrhythmic patient No
Secondary Production of valve interstitial cells modele from skin fibroblast of patient with a valvulopathy No