Collect of Cord Blood From Subjects at Risk for Sickle Ce... | NCT03876821

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

NCT03876821

Sponsor

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

Status

Completed

Last Update Posted

Nov 18, 2025Actual

Enrollment

44Actual

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 23, 2019Actual

Primary Completion Date

Oct 23, 2023Actual

Completion Date

Oct 23, 2023Actual

First Submitted Date

Feb 27, 2019

First Submission Date that Met QC Criteria

Mar 13, 2019

First Posted Date

Mar 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2025

Last Update Posted Date

Nov 18, 2025Actual

Name	Class
Centre Hospitalier Sud Francilien	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

44Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Giving birth

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Luc Rigonnot, MD	CHSF	Principal Investigator
Anne Galy, PhD	Institut National de la Santé Et de la Recherche Médicale, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHSF		Corbeil-Essonnes		91106	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39504955	Result	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.

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases