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

April 6, 2026 updated by: New York Blood Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

9999

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: National Cord Blood Program, New York Blood Center (General)
  • Phone Number: 917-710-9143
  • Email: ncbp@nybc.org

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Children's of Alabama
        • Principal Investigator:
          • Loretta Parker, MD
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Roberta H. Adams, MD
      • Phoenix, Arizona, United States, 85054
        • Completed
        • Mayo Clinic Arizona
      • Tucson, Arizona, United States, 85724
        • Completed
        • University of Arizona Medical Center
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Monzr Al Malki, MD
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Moores Cancer Center
        • Principal Investigator:
          • Edward Ball, MD
      • Los Angeles, California, United States, 90048
        • Completed
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Completed
        • UCLA Healthcare
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital
        • Principal Investigator:
          • Eric J Anderson, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Principal Investigator:
          • Andrew Rezvani, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Principal Investigator:
          • Jonathan Gutman, MD
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • The Children's Hospital of Colorado
        • Principal Investigator:
          • Michael Verneris, MD
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian / St. Luke'S Medical Center
        • Principal Investigator:
          • Alireza Eghtedar, MD
    • Delaware
      • Wilmington, Delaware, United States, 19901
        • Recruiting
        • Alfred I. DuPont Hospital for Children
        • Principal Investigator:
          • Emi Caywood, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Principal Investigator:
          • David A. Jacobsohn, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemour's Children's Clinic and Hospital
        • Principal Investigator:
          • Edward D Ziga, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami/Jackson Memorial Hospital
        • Principal Investigator:
          • Edward D. Ziga, MD
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami Health System Sylvester Comprehensive Cancer Center
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Florida Hospital, Florida Center for Cellular Therapy
        • Principal Investigator:
          • Rushang D. Patel, MD
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • All Children's Hospital, John Hopkins Medicine
        • Principal Investigator:
          • Deepakbabu Chellapandian, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Children's Healthcare of Atlanta
        • Principal Investigator:
          • Ann Haight, MD
      • Atlanta, Georgia, United States, 30242
        • Recruiting
        • Northside Hosptal
        • Principal Investigator:
          • Scott R Solomon, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Principal Investigator:
          • Sonali Chaudhuri, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Kehinde Adekola, MD
      • Maywood, Illinois, United States, 60153
        • Completed
        • Loyola University Medical Center
      • Zion, Illinois, United States, 60099
        • Completed
        • Midwestern Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Jodi Lynn S. Skiles, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40102
        • Recruiting
        • James Graham Brown Cancer Center
        • Principal Investigator:
          • Mohamed Hegazi, MD
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health
        • Principal Investigator:
          • Richard Childs, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Yi-Bin Chen, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • David Avigan, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Instistute
        • Principal Investigator:
          • Corey Cutler, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Principal Investigator:
          • Edward Peres, MD
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Principal Investigator:
          • Roland Chu, MD
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital
        • Principal Investigator:
          • Troy Quigg, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Completed
        • Mayo Clinic Rochester
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
        • Principal Investigator:
          • Carolyn L. Bigelow, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center
        • Principal Investigator:
          • Geoffrey Uy, MD
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • St. Louis University Hospital
        • Principal Investigator:
          • Sagun Goyal, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • The Nebraska Medical Center
        • Principal Investigator:
          • Sachit Patel, MD
        • Contact:
          • Sachit Patel, MD
    • New York
      • Lake Success, New York, United States, 10042
        • Recruiting
        • NorthWell Health - North Shore University Hospital
        • Principal Investigator:
          • Ruthee-Lu Bayer, MD
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • Cohen Children's Medical Center of NY
        • Principal Investigator:
          • Joel A Brochstein, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Alla Keyzner, MD
      • New York, New York, United States, 10021
        • Recruiting
        • New York Presbyterian Hospital WCMC
        • Principal Investigator:
          • Tsiporah Shore, MD
      • New York, New York, United States, 10067
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Principal Investigator:
          • Ioannis Politikos, MD
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center
        • Principal Investigator:
          • Omar Aljitawi, MD
    • Ohio
      • Akron, Ohio, United States, 44308
        • Recruiting
        • Akron Children's Hospital
        • Principal Investigator:
          • Megan Sampson, MD
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • Stella Davies, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Craig Sauter, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Seidman Cancer Center
        • Principal Investigator:
          • Brenda Cooper, MD
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Principal Investigator:
          • Hemalatha Rangarajan, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Arthur G. James Cancer Hospital
        • Principal Investigator:
          • Sumithara Vasu, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Stephenson Oklahoma Cancer Center
        • Principal Investigator:
          • George Selby, MD
      • Tulsa, Oklahoma, United States, 74133
        • Completed
        • Southwestern Regional Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Doernbecher Children's Hospital / Oregon Health & Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health / Penn State Milton S. Hershey Medical Center
        • Contact:
          • Robert Greiner, MD
        • Principal Investigator:
          • Robert Greiner, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Tim Olson, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Abramson Cancer Center of the University of Pennsylvania Medical Center
        • Principal Investigator:
          • Elizabeth Hexner, 19104
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hopsital of Pittsburgh of UPMC
        • Principal Investigator:
          • Paul Szabolcs, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • Jennifer Jaroscak, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Recruiting
        • St Jude Children's Research Center
        • Principal Investigator:
          • Renee Madden, MD
    • Texas
      • Dallas, Texas, United States, 75390-9063
        • Recruiting
        • Children's Medical Center Of Dallas
        • Principal Investigator:
          • Victor Aquino, MD
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center
        • Principal Investigator:
          • Gretchen M Eames, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Cancer Center
        • Principal Investigator:
          • Robert Krance, MD
      • San Antonio, Texas, United States, 78229
        • Completed
        • Methodist Hospital / Texas Transplant Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22905
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Karen Ballen, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University Massey Cancer Center
        • Principal Investigator:
          • John McCarty, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
        • Principal Investigator:
          • Ann Dahlberg, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Hospitals Inc
        • Contact:
          • Kelly Ross, MD
        • Principal Investigator:
          • Kelly Ross, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Hospital and Clinics
        • Principal Investigator:
          • Christian Capitini, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Principal Investigator:
          • David A Margolis, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: unlicensed CBU
The Principal Investigators will be the transplant physicians at participating US transplant centers
Biological: unlicensed CBU
infusion of unlicensed cord blood units

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of infusion-related reactions
Time Frame: within 48 hours of infusion
The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. 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 cord blood units.
within 48 hours of infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
engraftment
Time Frame: six months after transplant
This outcome will evaluate engraftment of unlicensed cord blood units
six months after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Blood Center

Investigators

  • Principal Investigator: Eric Gehrie, MD, New York Blood Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

July 31, 2012

First Submitted That Met QC Criteria

July 31, 2012

First Posted (Estimated)

August 3, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 6637-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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