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A multicenter safety study of unlicensed investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients

Investigation of Safety in Cord Blood Unit Administration

Recruiting
100 years and younger
All
Phase N/A

This study investigates the safety of administering investigational cord blood units. Cord blood is the blood that remains in the umbilical cord and placenta after birth, and it contains special cells called stem cells that can be used in medical treatments. The study aims to carefully document any problems related to the infusion of these units.

Participants in the study will receive investigational cord blood units, and the study will monitor for any infusion-related issues. The procedures will involve close observation and documentation of any side effects or complications that occur during the infusion process.

  • Who can participate: Both children and adults can join this study. They must have certain conditions like blood cancers or specific genetic disorders such as Hurler syndrome, Krabbe Disease, X-linked Adrenoleukodystrophy, primary immunodeficiency diseases, bone marrow failure, and beta-thalassemia. Patients receiving only licensed cord blood units or those at international transplant centers are excluded.
  • Study details: Participants will receive investigational cord blood units and will be monitored for any infusion-related problems. The study involves documenting side effects or complications that occur during the infusion process.
Study details
    Blood Transfusion

TX2794

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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