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Infusion ReactionsPhase 2NCT01656603

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

A Phase 2 study testing unlicensed CBU in people with Infusion Reactions, run by New York Blood Center at 71 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Any age
Conditions the study is for
Infusion Reactions
What is being tested?
unlicensed CBU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,999 participants
Where
71 sitesUnited States
Study dates
Feb 2012to Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

71 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dorothy Sung contact

718-706-5202

dsung@nybc.org

National Cord Blood Program, New York Blood Center (General) contact

917-710-9143

ncbp@nybc.org

71 sites in 1 country

United States71 sites, 60 recruiting

  • Akron Children's Hospital

    Akron, Ohio, 44308

    Megan Sampson, MD

    Recruiting

  • Northside Hosptal

    Atlanta, Georgia, 30242

    Scott R Solomon, MD

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

    Ann Haight, MD

    Recruiting

  • The Children's Hospital of Colorado

    Aurora, Colorado, 80045

    Michael Verneris, MD

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Jonathan Gutman, MD

    Recruiting

  • National Institutes of Health

    Bethesda, Maryland, 20892

    Richard Childs, MD

    Recruiting

  • Children's of Alabama

    Birmingham, Alabama, 35233

    Loretta Parker, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Yi-Bin Chen, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    David Avigan, MD

    Recruiting

  • Dana Farber Cancer Instistute

    Boston, Massachusetts, 02215

    Corey Cutler, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Jennifer Jaroscak, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22905

    Karen Ballen, MD

    Recruiting

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Sonali Chaudhuri, MD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Kehinde Adekola, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Stella Davies, MD

    Recruiting

  • Seidman Cancer Center

    Cleveland, Ohio, 44106

    Brenda Cooper, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Craig Sauter, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Hemalatha Rangarajan, MD

    Recruiting

  • Arthur G. James Cancer Hospital

    Columbus, Ohio, 43210

    Sumithara Vasu, MD

    Recruiting

  • Children's Medical Center of Dallas

    Dallas, Texas, 75390-9063

    Victor Aquino, MD

    Recruiting

  • Presbyterian / St. Luke's Medical Center

    Denver, Colorado, 80218

    Alireza Eghtedar, MD

    Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Roland Chu, MD

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Edward Peres, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Monzr Al Malki, MD

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Gretchen M Eames, MD

    Recruiting

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Troy Quigg, MD

    Recruiting

  • Penn State Health / Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Robert Greiner, MD

    Robert Greiner, MD

    Recruiting

  • Texas Children's Cancer Center

    Houston, Texas, 77030

    Robert Krance, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46204

    Jodi Lynn S. Skiles, MD

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Carolyn L. Bigelow, MD

    Recruiting

  • Nemour's Children's Clinic and Hospital

    Jacksonville, Florida, 32207

    Edward D Ziga, MD

    Recruiting

  • UCSD Moores Cancer Center

    La Jolla, California, 92093

    Edward Ball, MD

    Recruiting

  • Northwell Health - North Shore University Hospital

    Lake Success, New York, 10042

    Ruthee-Lu Bayer, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Completed

  • UCLA Healthcare

    Los Angeles, California, 90095

    Completed

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40102

    Mohamed Hegazi, MD

    Recruiting

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

    Christian Capitini, MD

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Completed

  • St Jude Children's Research Center

    Memphis, Tennessee, 38105

    Renee Madden, MD

    Recruiting

  • University of Miami Health System Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Completed

  • University of Miami/Jackson Memorial Hospital

    Miami, Florida, 33136

    Edward D. Ziga, MD

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    David A Margolis, MD

    Recruiting

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26506

    Kelly Ross, MD

    Kelly Ross, MD

    Recruiting

  • Cohen Children's Medical Center of NY

    New Hyde Park, New York, 11042

    Joel A Brochstein, MD

    Recruiting

  • New York Presbyterian Hospital WCMC

    New York, New York, 10021

    Tsiporah Shore, MD

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Alla Keyzner, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10067

    Ioannis Politikos, MD

    Recruiting

  • Stephenson Oklahoma Cancer Center

    Oklahoma City, Oklahoma, 73104

    George Selby, MD

    Recruiting

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

    Sachit Patel, MD

    Sachit Patel, MD

    Recruiting

  • Florida Hospital, Florida Center for Cellular Therapy

    Orlando, Florida, 32804

    Rushang D. Patel, MD

    Recruiting

  • Abramson Cancer Center of the University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

    Elizabeth Hexner, 19104

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Tim Olson, MD

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Roberta H. Adams, MD

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Completed

  • Children's Hopsital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Paul Szabolcs, MD

    Recruiting

  • Doernbecher Children's Hospital / Oregon Health & Science University

    Portland, Oregon, 97239

    Completed

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

    John McCarty, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Completed

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Omar Aljitawi, MD

    Recruiting

  • Methodist Hospital / Texas Transplant Institute

    San Antonio, Texas, 78229

    Completed

  • Rady Children's Hospital

    San Diego, California, 92123

    Eric J Anderson, MD

    Recruiting

  • Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance

    Seattle, Washington, 98109

    Ann Dahlberg, MD

    Recruiting

  • Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center

    St Louis, Missouri, 63110

    Geoffrey Uy, MD

    Recruiting

  • St. Louis University Hospital

    St Louis, Missouri, 63110

    Sagun Goyal, MD

    Recruiting

  • All Children's Hospital, John Hopkins Medicine

    St. Petersburg, Florida, 33701

    Deepakbabu Chellapandian, MD

    Recruiting

  • Stanford Health Care

    Stanford, California, 94305

    Andrew Rezvani, MD

    Recruiting

  • University of Arizona Medical Center

    Tucson, Arizona, 85724

    Completed

  • Southwestern Regional Medical Center

    Tulsa, Oklahoma, 74133

    Completed

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    David A. Jacobsohn, MD

    Recruiting

  • Alfred I. DuPont Hospital for Children

    Wilmington, Delaware, 19901

    Emi Caywood, MD

    Recruiting

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

    Completed

Other trials in United States

About this study

Official title: 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.

Read the 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).

Being tested
unlicensed CBU
Keywords
cord blood, transplantation, stem cells, adverse event

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • unlicensed CBUBiological

    infusion of unlicensed cord blood units

Study groups in NCT01656603
Study groupRoleWhat they receive
unlicensed CBUExperimentalThe Principal Investigators will be the transplant physicians at participating US transplant centers
Receives: Biological: unlicensed CBU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of infusion-related reactions

    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.

    Measured: within 48 hours of infusion

Secondary outcomes (1)

  1. engraftment

    This outcome will evaluate engraftment of unlicensed cord blood units

    Measured: six months after transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9,999 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01656603
Sponsor's protocol ID
6637-01
Status last verified
Apr 2026
First submitted
31 Jul 2012
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing unlicensed CBU in people with Infusion Reactions, run by New York Blood Center at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dorothy Sung (718-706-5202, dsung@nybc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of infusion-related reactions (time frame: within 48 hours of infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01656603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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