Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research
Completed
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT03876821
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Brief Summary
The study consists in collecting umbilical cord blood cells from newborns at risk of sickle cell disease, to perform laboratory experiments aiming to characterize the cells with HbS/HbS mutation, to develop methods to prepare, to gene-modify and to preserve these cells.
- Detailed Description
Pregnant individuals carrying at least one HbS allele will be included in the study to collect the umbilical cord blood of the child at birth. Collected cells will be used anonymously for genetic and bioexperimental laboratory research, aiming to develop autologous gene therapy for sickle cell disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 44
Inclusion Criteria
- Pregnant women, giving birth at CHSF and consenting to the collect and study of placental blood after delivery
- Age 18 to 45 years
- Biological testing of the participant includes hemoglobin electrophoresis and shows at least one HbS allele
Exclusion Criteria
- Lack of written consent
- Minors (not 18 years old) or under guardianship
- Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of samples with HbS/HbS genotype 3 years Measured by DNA sequencing
- Secondary Outcome Measures
Name Time Method Number of samples with bio-experimental data 4 years Consisting of cellular characterization, transduction and cell processing data
Trial Locations
- Locations (1)
CHSF
🇫🇷Corbeil-Essonnes, France