Safety Study of Unlicensed Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

  • STATUS
    Recruiting
  • participants needed
    9999
  • sponsor
    New York Blood Center
Updated on 17 January 2021
Investigator
Dorothy Sung
Primary Contact
Children's National Medical Center (5.4 mi away) Contact
+64 other location

Summary

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Description

The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.

Definitions of Infusion-related adverse reactions:

Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.

Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).

Details
Treatment unlicensed CBU
Clinical Study IdentifierNCT01656603
SponsorNew York Blood Center
Last Modified on17 January 2021

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