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

NCT03876821 | Completed

• 1 other identifier: C18-31
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Number of samples with HbS/HbS genotype

  Measured by DNA sequencing

  3 years

Secondary Outcomes (1)

• Number of samples with bio-experimental data

  4 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Giving birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Lack of written consent
• Minors (not 18 years old) or under guardianship
• Diseases : HIV, Hepatitis B, Hepatitis C or HTLV (Human T Leukemia Virus).

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Centre Hospitalier Sud Francilien: collaborator

Study Sites (1)

CHSF

Corbeil-Essonnes, 91106, France

Location

Related Publications (1)

• 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.

  PMID: 39504955 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA from cord blood cells.

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Luc Rigonnot, MD

  CHSF

  PRINCIPAL INVESTIGATOR

• Anne Galy, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 15, 2019
• Study Start: October 23, 2019
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: November 18, 2025

Record last verified: 2024-05

Locations

FR (1)