Trial document




drksid header

  DRKS00009433

Trial Description

start of 1:1-Block title

Title

Generation of induced pluripotent stem cells from somatic cells of healthy individuals and patients with inherited heart diseases

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

UKK-iPSC

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This is an non-interventional study, which means that no diagnostic or therapeutic measures will be carried out on study participants. Study participants will be required only to donate a small piece of their tissue (skin, blood and urine), after which their participation in this project is considered to be terminated. Donated tissue will be further processed in the lab to isolate specific cells, from which the so called, induced pluripotent stem cells (iPS cells) will be generated. The iPS cells are very special cells because they can grow in culture over long periods of time and under specific conditions they can be induced to make more differentiated cells of our body, such as heart muscle cells, liver cells or neurons. Scientists can use these patient-specific cells to test new drugs or study the disease mechanisms. This is especially important for diseases in which similar tissue samples can not be obtained from living patients, such as those with neurodegenerative or heart diseases. iPS cells generated in this project will be deposited in the "European bank for induced pluripotent stem cells (EBiSC)" and made available to researchers in the academia and industry worldwide to study the diseases and develop new medicines.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In this non-interventional study tissue samples (skin biopsy, peripheral blood and urine) will be collected from patients with inherited heart diseases and healthy donors. These samples will be processed in the lab to isolate corresponding adult cells (fibroblasts, lymphocytes, epithelial cells). In the next step, these cells will be converted into a, so called, induced pluripotent stem cells (iPS cells), by overexpression of a specific set of pluripotency factors. iPS cells can be propagated in culture for long periods of time and under specific conditions differentiated into mature cells of an adult organism, such as cardiomyocytes, hepatocytes and different types of neural cells. The aim of this project is to assemble a large collection of iPS cells from healthy donors and from patients with inherited heart diseases and to deposit these cells in the stem cell bank called "European bank of induced pluriponetnt stem cells (EBiSC)". The primary goal of this bank is to store well-characterized iPS cell lines and to provide them to researchers in academia and industry around the world to test new drugs and investigate the pathophysiology of diseases.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009433
  •   2015/10/02
  •   [---]*
  •   yes
  •   Approved
  •   14-306, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   inherited cardiomyopathies
  •   inherited heart rhythm disturbances
  •   healthy probands
  •   I42 -  Cardiomyopathy
  •   I45 -  Other conduction disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   tissue donation (skin biopsy, peripheral blood, urine) from patients with inherited cardiomyopathies and inherited arrhythmias
  •   tissue donation (skin biopsy, peripheral blood, urine) from healthy age and sex matched individuals
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Isolation of cells from a skin biopsy, peripheral blood or urine

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Successful generation of induced pluripotent stem cells (iPS cells) from somatic cells of healthy individuals or patients with inherited heart diseases

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/03/07
  •   35
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- for patients: signed consent form, dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, inborn arrhythmias (CPVT, LQTS, Brugada syndrome), legal capacity.
- for healthy tissue donors: signed consent form, no known acute or chronic diseases, legal capacity

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

infectious diseases (HIV, HCV, HBV), disseminated skin diseases or infections, urogenital infections, allergies against local anesthetics (e.g. Lidocain), blood clotting disturbances in test persons without heart diseases, persons in employment contract with the sponsor of the study, involuntary commitment into the mental hospital due to official or judicial order.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Zentrum für Physiologie und Pathophysiologie,Institut für Neurophysiologie, Medizinische FakultätUniklinik KölnTel.: (0221) 478-86686Fax: (0221) 478-3834E-mail: tomo.saric@uni-koeln.de
    • Mr.  Dr. med. Dr. sci.  Tomo  Saric 
    • Robert Koch Straße 39
    • 50931  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Herzzentrum der Uniklinik Köln, Abteilung für Elektrophysiologie,
    • Mr.  Univ.-Prof. Dr. med.  Daniel  Steven 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Universitätsklinikum MunsterInstitut für Genetik von Herzerkrankungen (IfGH)Department für Kardiologie und Angiologie
    • Mr.  Prof. Dr.  Eric  Schulze-Bahr 
    • Domagkstraße 3
    • 48149  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Zentrum für Physiologie und Pathophysiologie,Institut für Neurophysiologie, Medizinische FakultätUniklinik KölnTel.: (0221) 478-86686Fax: (0221) 478-3834E-mail: tomo.saric@uni-koeln.de
    • Mr.  Dr. med. Dr. sci.  Tomo  Saric 
    • Robert Koch Straße 39
    • 50931  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zentrum für Physiologie und Pathophysiologie,Institut für Neurophysiologie, Medizinische FakultätUniklinik KölnTel.: (0221) 478-86686Fax: (0221) 478-3834E-mail: tomo.saric@uni-koeln.de
    • Mr.  Dr. med. Dr. sci.  Tomo  Saric 
    • Robert Koch Straße 39
    • 50931  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Europäische Union
    • 1049  Brusseles
    • Belgium
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • European Federation of Pharmaceutical Industries and Associations (EFPIA)
    • Leopold Plaza Building, Rue du Trône 108
    • 1050 Ixelles  Brussels
    • Belgium
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.