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Clinical Trials/NCT01865981
NCT01865981
Completed
N/A

Cellular Reprogramming as a Tool to Characterise the Cellular Electrophysiology of Familial Arrhythmia

University of Dundee1 site in 1 country2 target enrollmentJune 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Eletrophysiology of iPS-derived Cardiomyocytes
Sponsor
University of Dundee
Enrollment
2
Locations
1
Primary Endpoint
Derivation of iPS cells
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells.

The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
June 1, 2017
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical features of Brugada Syndrome (ECG findings)
  • mutation positive or mutation negative
  • Idiopathic ventricular fibrillation

Exclusion Criteria

  • not able to give informed consent
  • Age less than 18 years
  • clinical diagnosis ambiguous

Outcomes

Primary Outcomes

Derivation of iPS cells

Time Frame: 12 months

Induced pluripotent cells will be derived from all participants in the study. Differences in the efficiency of iPS cell generation from different patients will be recorded, and correlated with disease status and age. iPS cell generation will be confirmed by pluripotency markers (stable endogenous gene expression of Nanog, Oct4, Sox2; colony formation; expression of SSEA4) and ability to differentiate in the absence of self-renewal stimulus (ability to self-renew in the absence of self-renewal stimulus -loss of markers above)

Secondary Outcomes

  • Electrophysiology on iPS-derived cardiomyocytes(12 months)
  • Differentiation of iPS cells to cardiomyocytes(12 months)

Study Sites (1)

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