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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease

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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• France
  • Corbeil-Essonnes, France, 91106
    • CHSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study includes pregnant women, aged 18-45 years of age, carrying at least one HbS allele, and who are followed and giving birth at the maternity unit of the Centre Hospitalier Sud Francilien in Evry, France.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of samples with HbS/HbS genotype	Measured by DNA sequencing	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of samples with bio-experimental data	Consisting of cellular characterization, transduction and cell processing data	4 years

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Centre Hospitalier Sud Francilien
• Investigators: Principal Investigator: Luc Rigonnot, MD, CHSF; Study Director: Anne Galy, PhD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• Mormin M, Rigonnot L, Chalumeau A, Miccio A, Fournier C, Pajanissamy S, Dewannieux M, Galy A. Cyclosporin H Improves the Transduction of CD34+ Cells with an Anti-Sickling Globin Vector, a Possible Therapeutic Approach for Sickle Cell Disease. Hum Gene Ther. 2024 Nov;35(21-22):896-903. doi: 10.1089/hum.2024.098. Epub 2024 Nov 6.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): October 23, 2023
• Study Completion (Actual): October 23, 2023

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hemic and Lymphatic Diseases; Anemia, Sickle Cell
• Other Study ID Numbers: C18-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No