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Cord blood banked for sickle cell: a step toward future cures

NCT ID NCT00012545

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study collected umbilical cord blood from over 300 newborns with sickle cell disease, sickle cell trait, or no disease to find the best ways to process and store it. The blood is rich in stem cells that might one day be used in treatments like gene therapy or transplants. The goal was to learn how to handle cord blood from different babies so it can be ready for future therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

307 people

The number who actually took part.

Started

Nov 2001

Finished

Oct 2023

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a pilot feasibility study for which umbilical cord blood samples will be collected and transported to the NIH Clinical Center for our developmental research. Pregnant women whose babies are at risk for sickle cell anemia will be identified and referred to the NIH Research Coordinator for evaluation and entry into the study. The NIH Research Coordinator is experienced in performing patient education and counseling concerning sickle cell disease, and obtaining informed consent.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: Pregnant women who are at risk of having an infant or infants (in case of multiple births) with sickle cell disease of the following types: Hemoglobin Sbeta 0 thalassemia Hemoglobin Sbeta + thalassemia Hemoglobin SC Hemoglobin SD Hemoglobin SE Hemoglobin SS Or other sickle-related variant determined acceptable by PI 1. Maternal subjects must be between 18 and 45 years old. 2. Maternal subjects must be able to provide informed consent. 3. Maternal subjects must work with their obstetrician to insure appropriate cord blood collection, sample collection, and completion of related documents. 4. Maternal subjects enrolled on other studies are not excluded, unless the other study may interfere with the present one. EXCLUSION CRITERIA: 1. The maternal subject will not be eligible for study if she is known to be positive for one or more of the following diseases transmissible by blood: HIV, hepatitis B, hepatitis C, WNV, HTLV or ZIKV. 2. Maternal subject will not be eligible for the study if she has active syphilis, toxoplasmosis, malaria or 3. Maternal subject will not be eligible for the study if the pregnancy resulted from egg donation or sperm donation. 4. Maternal subject is unable to give informed consent. 5. Maternal subject is known to have a fetus with a significant congenital anomaly, either not compatible with life, or requiring immediate surgical intervention or care in the Neonatal Intensive Care Unit. 6. Maternal subject has cancer or received treatment for cancer during pregnancy. 7. Infant is premature (\<34 weeks). 8. Maternal subject may be excluded at the time of delivery if the attending physician or collection staff deems that the cord blood collection is inadvisable, due to unanticipated obstetrical complications. 9. Cord blood received by CCBB/STLC is greater than 72 hours from collection

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Conditions

The condition(s) this trial relates to.

sickle cell disease Sickle Cell Trait

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.