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

Sickle Cell Disease Clinical Trial

— DREPACORD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03876821
• Other study ID #: C18-31
• Status: Not yet recruiting
• Start date: March 2019
• Est. completion date: March 2022

Study information

• Verified date: October 2018
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Ismahane GUIMIOT
• Phone: +33 (0)1 82 53 35 36
• Email: ismahane.guimiot[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Centre Hospitalier Sud Francilien

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of samples with HbS/HbS genotype	Measured by DNA sequencing	3 years
Secondary	Number of samples with bio-experimental data	Consisting of cellular characterization, transduction and cell processing data	4 years