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Clinical Trials/NCT03876821
NCT03876821
Completed
Not Applicable

Collect of Cord Blood From Subjects at Risk for Sickle Cell Disease, for the Purpose of Laboratory Research

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country44 target enrollmentOctober 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
44
Locations
1
Primary Endpoint
Number of samples with HbS/HbS genotype
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2019
End Date
October 23, 2023
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Number of samples with HbS/HbS genotype

Time Frame: 3 years

Measured by DNA sequencing

Secondary Outcomes

  • Number of samples with bio-experimental data(4 years)

Study Sites (1)

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