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
2 other identifiers
observational
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2018
CompletedFirst Submitted
Initial submission to the registry
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2019
CompletedSeptember 26, 2022
December 1, 2021
6 months
November 22, 2018
September 23, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Obtention of induced pluripotent stem cell line (iPS): yes/no
Was a pluripotent stem cell line obtained? yes/no
28 days
Secondary Outcomes (2)
Functional bronchial epithelium present for the iPS? yes/no
28 days
Cystic fibrosis transmembrane conductance regulator (CFTR) channel function: yes/no
28 days
Study Arms (2)
Cystic fibrosis
Three cystic fibrosis patients who are homozygous for the p.Phe508del mutation.
Healthy subjects
Three healthy subjects.
Eligibility Criteria
Three cystic fibrosis patients who are homozygous for the p.Phe508del mutation and 3 healthy subjects without cystic fibrosis.
You may qualify if:
- Homozygote for the p.Phe508del mutation
- Signed informed consent given by the subject
- Signed informed consent given by the subject
You may not qualify if:
- Pregnancy, breastfeeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, 34295, France
Biospecimen
Blood sample, RNA and induced pluripotent stem cell lines.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnaud Bourdin, MD, PhD
Montpellier University Hospitals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2018
First Posted
November 27, 2018
Study Start
November 5, 2018
Primary Completion
April 25, 2019
Study Completion
April 25, 2019
Last Updated
September 26, 2022
Record last verified: 2021-12