- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03754088
In Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via iPS Technology (PaCyFIC)
Initiation of an in Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via Induced Pluripotent Stem Cell Technology
Study Overview
Status
Conditions
Detailed Description
The investigator's primary objective is to generate iPS lines from 3 CF patients and from 3 healthy subjects.
Secondary objectives include verification that cell lines express the CFTR gene according to their genotype, verification or relative production of the CFTR protein for each iPS line, and amplification of obtain iPS lines for aliquot creation to facilitate sharing.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Montpellier, France, 34295
- Hôpital Arnaud de Villeneuve - CHU de Montpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for subjects with Cystic Fibrosis:
- Homozygote for the p.Phe508del mutation
- Signed informed consent given by the subject
Inclusion Criteria for subjects without Cystic Fibrosis:
- Signed informed consent given by the subject
Exclusion Criteria:
- Pregnancy, breastfeeding
- Participant in an exclusion period determined by a previous study
- Participant under any kind of guardianship
- Unaffiliated with or not a beneficiary of a social security program (health insurance)
- Subject deprived of liberty (e.g. prisoners)
- Subject with positive infectious markers for HIV1, HIV2, HBC or HBV
Exclusion Criteria for subjects with Cystic Fibrosis:
- Any pathology requiring a treatment or a pathology not requiring treatment but with clinical significance according to the investigator
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cystic fibrosis
Three cystic fibrosis patients who are homozygous for the p.Phe508del mutation.
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Healthy subjects
Three healthy subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obtention of induced pluripotent stem cell line (iPS): yes/no
Time Frame: 28 days
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Was a pluripotent stem cell line obtained?
yes/no
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional bronchial epithelium present for the iPS? yes/no
Time Frame: 28 days
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Was a functional bronchial epithelium present for the iPS? yes/no
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28 days
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Cystic fibrosis transmembrane conductance regulator (CFTR) channel function: yes/no
Time Frame: 28 days
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CFTR channel function demonstrated via response following exposure to modified oligonucleotides targeting the mutated CFTR transcript.
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28 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnaud Bourdin, MD, PhD, Montpellier University Hospitals
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL17_0254
- 2017-A02341-52 (OTHER: RCB number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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