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Unlicensed cord blood units under safety spotlight in new trial

NCT ID NCT01656603

Disease control Sponsor: New York Blood Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is checking whether unlicensed cord blood units are safe to use for stem cell transplants in children and adults with blood disorders. Researchers will closely watch for any infusion-related problems. The goal is to see if these units can be a safe option for patients who need a transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
unlicensed cord blood units
What this could lead to
If successful, this could show that these cord blood units are safe to use for stem cell transplants, potentially expanding access for patients with blood disorders.
What could go wrong
This is an early safety study, not designed to prove effectiveness. Infusion reactions or other complications may still occur, and the unlicensed status means these units are not yet approved by regulators.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 9,999 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Feb 2012

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.)

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

hematologic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infusion reactions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    60 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abramson Cancer Center of the University of Pennsylvania Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44308, United States

  • Alfred I. DuPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19901, United States

  • All Children's Hospital, John Hopkins Medicine

    RECRUITING

    St. Petersburg, Florida, 33701, United States

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

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Arthur G. James Cancer Hospital

    RECRUITING

    Columbus, Ohio, 43210, United States

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

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cedars Sinai Medical Center

    COMPLETED

    Los Angeles, California, 90048, United States

  • Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Children's Hopsital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Medical Center of Dallas

    RECRUITING

    Dallas, Texas, 75390-9063, United States

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Children's of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cohen Children's Medical Center of NY

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Dana Farber Cancer Instistute

    RECRUITING

    Boston, Massachusetts, 02215, United States

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

    COMPLETED

    Portland, Oregon, 97239, United States

  • Florida Hospital, Florida Center for Cellular Therapy

    RECRUITING

    Orlando, Florida, 32804, United States

  • Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance

    RECRUITING

    Seattle, Washington, 98109, United States

  • Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46204, United States

  • James Graham Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40102, United States

  • Loyola University Medical Center

    COMPLETED

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    COMPLETED

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    COMPLETED

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan-Kettering Cancer Center

    RECRUITING

    New York, New York, 10067, United States

  • Methodist Hospital / Texas Transplant Institute

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Midwestern Regional Medical Center

    COMPLETED

    Zion, Illinois, 60099, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • National Institutes of Health

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemour's Children's Clinic and Hospital

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • New York Presbyterian Hospital WCMC

    RECRUITING

    New York, New York, 10021, United States

  • Northside Hosptal

    RECRUITING

    Atlanta, Georgia, 30242, United States

  • Northwell Health - North Shore University Hospital

    RECRUITING

    Lake Success, New York, 10042, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

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

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Presbyterian / St. Luke's Medical Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • Rady Children's Hospital

    RECRUITING

    San Diego, California, 92123, United States

  • Seidman Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Southwestern Regional Medical Center

    COMPLETED

    Tulsa, Oklahoma, 74133, United States

  • St Jude Children's Research Center

    RECRUITING

    Memphis, Tennessee, 38105, United States

  • St. Louis University Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Stanford Health Care

    RECRUITING

    Stanford, California, 94305, United States

  • Stephenson Oklahoma Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Texas Children's Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Children's Hospital of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • The Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • UCLA Healthcare

    COMPLETED

    Los Angeles, California, 90095, United States

  • UCSD Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Arizona Medical Center

    COMPLETED

    Tucson, Arizona, 85724, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami Health System Sylvester Comprehensive Cancer Center

    COMPLETED

    Miami, Florida, 33136, United States

  • University of Miami/Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22905, United States

  • University of Wisconsin Hospital and Clinics

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Virginia Commonwealth University Massey Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • West Virginia University Hospitals Inc

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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Other studies related to the condition(s) this trial covers.