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Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Study testing unlicensed cord blood for unrelated transplants.

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Phase 2
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  • Technical description (Original)

The study is testing the safety of certain cord blood units (CBU) from the National Cord Blood Program (NCBP). Cord blood is the blood collected from a baby's umbilical cord after birth. It contains special cells that can help treat diseases affecting the blood. This study focuses on how safe these CBUs are when given to patients who don't have a match from a related donor. A key part of the study is looking for infusion-related reactions or problems that can happen when the cord blood is given to a patient. These reactions range from mild, needing some care, to severe, which could be life-threatening.

  • Eligibility: Patients with blood disorders, regardless of age or gender, can join if they receive NCBP-manufactured cord blood.
  • Exclusions: Patients using only licensed or other bank's cord blood, or having transplants outside the US, cannot join.
  • Risks: Possible reactions include severe medical issues like heart, lung, or kidney failure, seizures, or death within 48 hours of infusion.
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Study details
    Infusion Reactions

NCT01656603

New York Blood Center

13 December 2024

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