UPCC 12412 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

Study on Safety of Investigational Cord Blood Units for Stem Cell Transplantation

Enrolling By Invitation
All
Phase 2
9999 participants needed
1 Location

Brief description of study

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

Detailed description of study

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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Infusion Reactions
  • Gender: All

Inclusion Criteria:

  1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
  2. Patients: Patients of any age and either gender
  3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)

Exclusion Criteria:

  1. Patients who are receiving licensed cord blood products (only)
  2. Patients who are receiving unlicensed cord blood products from other banks (only)
  3. Patients who are transplanted at non-US transplant centers
  4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)

This study investigates the safety of using investigational cord blood units for hematopoietic stem cell transplantation in pediatric and adult patients. The purpose of this study is to monitor and evaluate any infusion-related reactions that occur when these investigational cord blood units are administered.

Participants in the study will receive investigational cord blood units, and researchers will document any adverse reactions during or after the infusion. These reactions will be categorized by severity, with mild to moderate reactions requiring some medical intervention, and severe reactions being life-threatening or fatal, necessitating major medical interventions. The study will utilize a standardized grading system to classify these reactions.

  • Who can participate: Patients of any age with disorders affecting the hematopoietic system, whether inherited, acquired, or resulting from myeloablative treatment, may participate. Participants must receive at least one investigational cord blood product manufactured by the NCBP.
  • Study details: Participants will receive investigational cord blood units, and researchers will monitor for any infusion-related reactions. The study focuses on documenting these reactions to assess safety.
Updated on 13 Apr 2026. Study ID: 12-0062
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