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

Description

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

Conditions

Infusion Reactions

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Study Overview

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Study Details

Study overview

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

A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients

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

Condition
Infusion Reactions
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Phoenix

Mayo Clinic Arizona, Phoenix, Arizona, United States, 85054

Tucson

University of Arizona Medical Center, Tucson, Arizona, United States, 85724

Duarte

City of Hope, Duarte, California, United States, 91010

La Jolla

UCSD Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

UCLA Healthcare, Los Angeles, California, United States, 90095

San Diego

Rady Children's Hospital, San Diego, California, United States, 92123

Stanford

Stanford Health Care, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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.)

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York Blood Center,

Patricia Shi, MD, PRINCIPAL_INVESTIGATOR, NY Blood Center

Study Record Dates

2025-12