In Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via iPS Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-04-25

Brief Summary

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In order to further enable physiopathology studies, the aim of this project is to validate an in vitro model of cystic fibrosis created using induced pluripotent stemcell (iPS) differentiated bronchial epithelium from cystic fibrosis (CF) patients homozygous for the p.Phe508del mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cystic fibrosis

Three cystic fibrosis patients who are homozygous for the p.Phe508del mutation.

No interventions assigned to this group

Healthy subjects

Three healthy subjects.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Homozygote for the p.Phe508del mutation
* Signed informed consent given by the subject

* 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

* Any pathology requiring a treatment or a pathology not requiring treatment but with clinical significance according to the investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes