AzTrials
AzTrials

Hematologic MalignanciesNCT01351545

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

An observational study of Hematologic Malignancies and Inherited Disorders of Metabolism, run by Center for International Blood and Marrow Transplant Research at 142 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
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Trial summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications. Read more about this study

Who is it for?
Any age
What is being tested?
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
How many people
99,999 participants
Where
142 sitesUnited States
Study dates
Oct 2011to Oct 2041
Phase
Observational
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

Study population: Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.

Who may be able to join

  • Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  • Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  • Pediatric and adult patients of any age

Who cannot join

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  • Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  • Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

Trial locations and contacts

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

Elizabeth Fosberg, B.A. contact

10-CBA@ndmp.org

142 sites in 1 country

United States142 sites, 113 recruiting

  • Childrens Hospital Medical Center of Akron

    Akron, Ohio, 44308

    Megan Sampson, MD, msampson@akronchildrens.org

    Megan Sampson, MD

    Recruiting

  • Amarillo Blood and Marrow Transplant Program

    Amarillo, Texas, 79106

    Terminated

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Jessica Yu, jjxyu@med.umich.edu

    Gregory Yanik, M.D.

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

    Alan Bidgoli, MD, 404-875-4197, alan.bidgoli@choa.org

    Alan Bidgoli, MD

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Terminated

  • Northside Hospital

    Atlanta, Georgia, 30342

    Scott Solomon, MD, ssolomon@bmtga.com

    Scott Solomon, MD

    Recruiting

  • Georgia Cancer Center at Augusta University Health

    Augusta, Georgia, 30912

    Vamsi K Kota, MD, vkota@augusta.edu

    Vamsi K Kota, MD

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Michael Verneris, MD, MICHAEL.VERNERIS@CUANSCHUTZ.EDU

    Michael Verneris, MD

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Jonathan Gutman, MD, jonathan.gutman@ucdenver.edu

    Jonathan Gutman, MD

    Recruiting

  • Greenebaum Cancer Center - University of Maryland

    Baltimore, Maryland, 21201

    Withdrawn

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Allen Chen, MD, PhD, allenchen@jhmi.edu

    Allen Chen, MD, PhD

    Recruiting

  • Indiana Blood & Marrow Transplantation

    Beech Grove, Indiana, 46107

    Withdrawn

  • Nih/Niaid

    Bethesda, Maryland, 20892-1456

    Elizabeth Kang, MD, ekang@niaid.nih.gov

    Elizabeth Kang, MD

    Recruiting

  • NIH/NCI

    Bethesda, Maryland, 20892

    Active, not recruiting

  • Nih/Nhlbi

    Bethesda, Maryland, 20892

    Richard Childs, MD, childsr@nih.gov

    Richard Childs, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Joseph Chewning, MD, jchewning@peds.uab.edu

    Joseph Chewning, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Andreas Klein, MD, 617-636-8884, aklein2@tuftsmedicalcenter.org

    Andreas Klein, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Suspended

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

    David Avigan, MD, davigan@bidmc.harvard.edu

    David Avigan, MD

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Corey Cutler, MD, cscutler@partners.org

    Cory Cutler, MD

    Recruiting

  • Nemours - Alfred I. duPont Hospital for Children

    Brandywine, Delaware, 19803

    Emi Caywood, MD, ecaywood@nemours.org

    Emi Caywood, MD

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Kanwaldeep Mallhi, MD, (716) 845-2333, Kanwaldeep.Mallhi@RoswellPark.org

    Kanwaldeep Mallhi, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Anson Snow, MD, 984-974-1000, Anson.Snow@unchealth.unc.edu

    Anson Snow, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Michelle Hudspeth, MD, 843-792-2957, hudspeth@musc.edu

    Michelle Hudspeth, MD

    Recruiting

  • Levine Children's Hospital

    Charlotte, North Carolina, 28203

    Jeffrey Huo, MD, Jeffrey.Huo@carolinashealthcare.org

    Michelle Hyland, Michelle.Hyland@carolinashealthcare.org

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Karen Ballen, MD, KB3TC@hscmail.mcc.virginia.edu

    Karen Ballen, MD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Kehinde Adekola, MD, kehinde-adekola@northwestern.edu

    Kehinde Adekola, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Sunita Nathan, MD

    Sunita Nathan, MD

    Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

    Damiano Rondelli, MD, drond@uic.edu

    Damiano Rondelli, MD

    Recruiting

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

    Chicago, Illinois, 60614

    Sonali Chaudhury, MD, schaudhury@luriechildrens.org

    Sonali Chaudhury, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    James LaBelle, MD, PhD, jlabelle@peds.bsd.uchicago.edu

    James LaBelle, MD, PhD

    Recruiting

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229

    Stella Davies, MD, stella.davies@cchmc.org

    Stella Davies, MD

    Recruiting

  • The Jewish Hospital

    Cincinnati, Ohio, 45230

    Withdrawn

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

    Hillard Lazarus, MD, hillard.lazarus@case.edu

    Hillard Lazarus, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Claudio Brunstein, MD, (216) 445-0910, brunstc@ccf.org

    Claudio Brunstein, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Rolla Abu-Arja, MD, rolla.abu-arja@nationwidechildrens.org

    Rolla Abu-Arja, MD

    Recruiting

  • The Arthur G. James Cancer Hospital/The Ohio State University Medical Center

    Columbus, Ohio, 43210

    Sumithira Vasu, MD, sumithira.vasu@osumc.edu

    Sumithira Vasu, MD

    Recruiting

  • Medical City Dallas

    Dallas, Texas, 75230

    Vikas Bhushan, MD, vikas.bhushan@usoncology.com

    Vikas Bhushan, MD

    Recruiting

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

    Victor Aquino, MD, Victor.aquino@utsouthwestern.edu

    Victor Aquino, MD

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Withdrawn

  • Presbyterian St. Luke's/Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Alireza Eghtedar, MD, alireza.eghtedar@healthonecares.com

    Alireza Eghtedar, MD

    Recruiting

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

    Sureyya Savasan, MD, ssavasan@med.wayne.edu

    Sureyya Savasan, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Suspended

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Nalini Janakiraman, MD, njanaki1@hfhs.org

    Nalini Janakiraman, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Monzr Al Malki, MD, malmalki@coh.org

    Monzr Al Malki, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27705

    Joanne Kurtzberg, MD, kurtz001@mc.duke.edu

    Joanne Kurtzberg, MD

    Recruiting

  • Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)

    Fort Sam Houston, Texas, 78234

    Gilbert Ancira, MD, 210-916-4808, gilbert.p.ancira.mil@health.mil

    Gilbert Ancira, MD

    Recruiting

  • Cook Children's Hospital

    Fort Worth, Texas, 76104

    Gretchen Eames, MD, gretchen.eames@cookchildrens.org

    Gretchen Eames, MD

    Recruiting

  • University of Florida Shands Medical Center

    Gainesville, Florida, 32610

    Jordan Milner, MD, 352-273-9120, jordan.milner@ufl.edu

    Jordan Milner, MD

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Matthew Ulrickson, MD, 480-256-3223, Matthew.Ulrickson@bannerhealth.com

    Matthew Ulrickson, MD

    Recruiting

  • Children's Hospital of Los Angeles

    Glendale, California, 91204

    Neena Kapoor, MD, nkapoor@chla.usc.edu

    Neena Kapoor, MD

    Recruiting

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

    Troy Quigg, MD, troy.quigg@spectrumhealth.org

    Troy Quigg, MD

    Recruiting

  • Spectrum Health

    Grand Rapids, Michigan, 49503

    Aly Abdel-Mageed, MD, aly.mageed@helendevoschildrens.org

    Aly Abdel-Mageed, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Alfred Gillio, MD, agillio@humed.com

    Alfred Gillio, MD

    Recruiting

  • Penn State Milton S. Hershey Cancer Center

    Hershey, Pennsylvania, 17033

    Shin Mineishi, MD, smineishi@pennstatehealth.psu.edu

    Shin Mineishi, MD

    Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96813

    Randal Wada, MD, randalw@hawaii.edu

    Randal Wada, MD

    Recruiting

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Elizabeth Shpall, MD, eshpall@mdanderson.org

    Elizabeth Shpall, MD

    Recruiting

  • Texas Children's Hospital - Baylor Medical Center

    Houston, Texas, 77030

    George Carrum, MD, 832-824-7695, gcarrum@houstonmethodist.org

    George Carrum, MD

    Recruiting

  • Indiana University/Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Jodi Skiles, MD, jskiles@iupui.edu

    Jodi Skiles, MD

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Margarida Silverman, MD, margarida-silverman@uiowa.edu

    Margarida Silverman, MD

    Recruiting

  • Univeristy of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Carter Milner, MD, 601-984-5613, capayne@umc.edu

    Carter Milner, MD

    Recruiting

  • Nemours Children's Hospital - Mayo Jacksonville

    Jacksonville, Florida, 32207

    Edward Ziga, MD, 904-697-2047, Edward.ziga@nemours.org

    Edward Ziga, MD

    Recruiting

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

    Withdrawn

  • Children's Mercy Hospital and Clinics

    Kansas City, Missouri, 64108

    Erin Hall, MD, 816-302-6808, emhall@cmh.edu

    Erin Hall, MD

    Recruiting

  • Scripps Green Hospital

    La Jolla, California, 92037

    James R Mason, MD, mason.james@scrippshealth.org

    James R Mason, MD

    Recruiting

  • University of California San Diego

    La Jolla, California, 92093

    Kaitlyn Dykes, MD, 8588226600, kcdykes@health.ucsd.edu

    Kaitlyn Dykes, MD

    Recruiting

  • North Shore University Hospital

    Lake Sucess, New York, 11042

    Ruthee L Bayer, MD, rbayer@nshs.edu

    Ruthee L Bayer, MD

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

    Jason Farrar, MD, JEFarrar@uams.edu

    Recruiting

  • Loma Linda University Cancer Center

    Loma Linda, California, 92350

    Hisham Abdel-Azim, MD, habdelazim@llu.edu

    Hisham Abdel-Azim, MD

    Recruiting

  • UCLA

    Los Angeles, California, 90095

    Gary Schiller, MD, 310-206-5755, gschiller@mednet.ucla.edu

    Gary Schiller, MD

    Recruiting

  • University of Louisville Hospital - James Brown Cancer Center

    Louisville, Kentucky, 40202

    Mohamed Hegazi, MD, mohamed.hegazi@louisville.edu

    Mohamed Hegazi, MD

    Recruiting

  • Southwest Cancer Treatment & Research Center

    Lubbock, Texas, 79415

    Withdrawn

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

    Kenneth DeSantes, MD, kbdesantes@pediatrics.wisc.edu

    Kenneth Desantes, MD

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Patrick Hagen, MD, patrick.hagen@lumc.edu

    Patrick Hagen, MD

    Recruiting

  • Methodist Healthcare Blood and Marrow Transplant Center

    Memphis, Tennessee, 38104

    Active, not recruiting

  • St. Jude Childrens Research Hospital

    Memphis, Tennessee, 38105

    Renee Madden, MD, renee.madden@stjude.org

    Renee Madden, MD

    Recruiting

  • University of Miami (adult)

    Miami, Florida, 33136

    Active, not recruiting

  • University of Miami (peds)

    Miami, Florida, 33136

    Edward Ziga, MD, MPH, e.ziga@med.miami.edu

    Edward Ziga, MD, MPH

    Recruiting

  • Niklaus Children's Hospital

    Miami, Florida, 33155

    Jorge Galvez-Silva, MD, jorgericardo.galvezsilva@nicklaushealth.org

    Jorge Galvez-Silva, MD

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    David Margolis, MD, dmargoli@mcw.edu

    David Margolis, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Active, not recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506-8110

    Lauren Veltri, MD, lveltri@hsc.wvu.edu

    Lauren Veltri, MD

    Recruiting

  • Sarah Cannon BMT Program

    Nashville, Tennessee, 37203

    Suspended

  • VA Tennessee Valley Healthcare System

    Nashville, Tennessee, 37212

    Withdrawn

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Michael Byrne, MD, michael.byrne@vumc.org

    Michael Byrne, MD

    Recruiting

  • Robert Wood Johnson/Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Matthew Matasar, MD, MS, mm3511@cinj.rutgers.edu

    Matthew Matasar, MD, MS

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

    Aaron Flagg, MD, aron.flagg@yale.edu

    Aaron Flagg, MD

    Recruiting

  • Cohen Children's Medical Center of New York

    New Hyde, New York, 11040

    Jonathan Fish, MD, jfish1@nshs.edu

    Jonathan Fish, MD

    Recruiting

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

    Withdrawn

  • Children's Hospital of New Orleans/LSUHSC

    New Orleans, Louisiana, 70118

    Maria Velez, MD, 504-896-9740, mvelez@lsuhsc.edu

    Maria Velez, MD

    Recruiting

  • New York University Langone Medical Center

    New York, New York, 10016

    Mohammad M Abdul Hay, MD, 312-315-2687, maher.abdulhay@nyulangone.org

    Antoine Mesidor, Antoine.Mesidor@nyulangone.org

    Recruiting

  • New York Presbyterian Hospital at Cornell

    New York, New York, 10021

    Tsiporah Shore, MD, tbs2001@med.cornell.edu

    Tsiporah Shore, MD

    Recruiting

  • Mount Sinai Medical Center - New York

    New York, New York, 10029

    Alla Keyzner, MD, alla.keyzner@mssm.edu

    Alla Keyzner, MD

    Recruiting

  • Columbia University Medical Center - Morgan Stanley Children's Hospital

    New York, New York, 10032

    Monica Bhatia, MD, mb2476@columbia.edu

    Monica Bhatia, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

    Ann Jakubowski, MD, 646-752-5174, jakubowa@mskcc.org

    Ann Jakubowski, MD

    Recruiting

  • Westchester Medical Center

    New York, New York, 10595

    Mitchell Cairo, MD, 914-594-3640, mitchell_cairo@nymc.edu

    Mitchell Cairo, MD

    Recruiting

  • Children's Hospital and Research Center of Oakland

    Oakland, California, 94609

    Active, not recruiting

  • University of Oklahoma Health Science Center

    Oklahoma City, Oklahoma, 73103

    Adam Asch, MD, adam-asch@ouhsc.edu

    Adam Asch, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

    Phyllis Warkenton, MD, pwarkent@unmc.edu

    Phyllis Warkenton, MD

    Recruiting

  • Children's Hospital of Orange County (CHOC)

    Orange, California, 92868

    Rishikesh Chavan, MD, rishikesh.chavan@choc.org

    Rishikesh Chavan, MD

    Recruiting

  • AdventHealth Orlando

    Orlando, Florida, 32804

    Rushang Patel, MD, rushang.patel.md@adventhealth.com

    Rushang Patel, MD

    Recruiting

  • Florida Center for Pediatric Cellular Therapy

    Orlando, Florida, 32804

    Susan Kelly, MD, susan.kelly.md@flhosp.org

    Susan Kelly, MD

    Recruiting

  • Orlando Health Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

    Rikin Shah, 321-842-9904, rikin.shah@orlandohealth.com

    Rikin Shah, MD

    Recruiting

  • Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy

    Orlando, Florida, 32806

    Yasser Khaled, MD, yasser.khaled@orlandohealth.com

    Yasser Khaled, MD

    Recruiting

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

    Terminated

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Timothy Olson, MD, 267-426-5516, olsont@email.chop.edu

    Timothy Olson, MD

    Recruiting

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

    Dana Salzberg, MD, 602-546-0920, dsalzberg@phoenixchildrens.com

    Dana Salzberg, MD

    Recruiting

  • Mayo Clinic Arizona (adults)

    Phoenix, Arizona, 85054

    Withdrawn

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Paul Szabolcs, MD, Paul.szabolcs@chp.edu

    Paul Szabolcs, MD

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Prerna Mewawalla, MD, 412-578-4484, pmewawalla26085@direct.ahn.org

    Prerna Mewawalla, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

    Alison Sehgal, MD, sehgalar@upmc.edu

    Alison Sehgal, MD

    Recruiting

  • University of Pennsylvania/Thomas Jefferson

    Pittsburgh, Pennsylvania, 19104

    Elizabeth Hexner, MD, elizabeth.hexner@uphs.upenn.edu

    Elizabeth Hexner, MD

    Recruiting

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

    Portland, Oregon, 97239

    Eneida Nemecek, MD, nemeceke@ohsu.edu

    Eneida Nemecek, MD

    Recruiting

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

    Suspended

  • Virginia Commonwealth University

    Richmond, Virginia, 23227

    John McCarty, MD, 804-828-4596, jmccarty@vcu.edu

    John McCarty, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Active, not recruiting

  • Strong Memorial Hospital/University of Rochester

    Rochester, New York, 14642-8704

    Omar Aljitawi, MD, omar_aljitawi@urmc.rochester.edu

    Omar Aljitawi, MD

    Recruiting

  • Sutter Medical Center

    Sacramento, California, 95816

    Elias Kiwan, MD, (916) 733-4400, elias.kiwan@sutterhealth.org

    Elias Kiwan, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Ahmad Rayes, MD, ahmad.rayes@hsc.utah.edu

    Ahmad Rayes, MD

    Recruiting

  • The Children's Hospital of San Antonio

    San Antonio, Texas, 78207

    Martin Andreansky, MD, PhD, martin.andreansky@bcm.edu

    Mark Schambura, Mark.schambura@christushealth.org

    Recruiting

  • Methodist Healthcare System of San Antonio/Texas Transplant Institute

    San Antonio, Texas, 78229

    Jose Cruz, MD, josecarlos.cruz@hcahealthcare.com

    Jose Cruz, MD

    Recruiting

  • Rady Children's Hospital San Diego

    San Diego, California, 92123

    Eric Anderson, MD, eanderson@rchsd.org

    Eric Anderson, MD

    Recruiting

  • UCSF (adults)

    San Francisco, California, 94143

    Active, not recruiting

  • UCSF (Peds)

    San Francisco, California, 94143

    Sandhya Kharbanda, MD, sandhya.kharbanda@ucsf.edu

    Sandhya Kharbanda, MD

    Recruiting

  • VA Puget Sound HCS

    Seattle, Washington, 98108

    Suspended

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

    Ann Dahlberg, MD, adahlber@fredhutch.org

    Ann Dahlberg, MD

    Recruiting

  • Avera Transplant Institute

    Sioux Falls, South Dakota, 57105

    Waqas Jehangir, MD, FACP, waqas.jehangir@avera.org

    Waqas Jehangir, MD, FACP

    Recruiting

  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

    Deepika Bhatla, MD, dbhatla@slu.edu

    Deepika Bhatla, MD

    Recruiting

  • St. Louis University Medical Center

    St Louis, Missouri, 63110

    Suspended

  • Washington University St. Louis

    St Louis, Missouri, 63110

    Geoffrey Uy, MD, guy@wustl.edu

    Geoffrey Uy, MD

    Recruiting

  • Washington University/St. Louis Children's Hospital

    St Louis, Missouri, 63110

    Geoffrey Uy, MD, guy@wustl.edu

    Geoffrey Uy, MD

    Recruiting

  • All Children's Hospital

    St. Petersburg, Florida, 33701

    Deepakbabu Chellapandian, MD, dchella2@jhmi.edu

    Deepakbabu Chellapandian, MD

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94304

    Andrew Rezvani, MD, arezvani@stanford.edu

    Andrew Rezvani, MD

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Michael Schuster, MD, mschuster@notes.cc.sunysb.edu

    Michael Schuster, MD

    Recruiting

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612

    Active, not recruiting

  • Children's Hospital at Montefiore

    The Bronx, New York, 10467

    Mahvish Rahim, MD, mrahim@montefiore.org

    David Loeb, MD, PhD

    Recruiting

  • University of Arizona Medical Center - Tucson

    Tucson, Arizona, 85224

    Emmanuel Katsanis, MD, katsanis@peds.arizona.edu

    Emmanuel Katsanis, MD

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    David Jacobsohn, MD, dajacobs@childrensnational.org

    David Jacobsohn, MD

    Recruiting

  • University of Kansas

    Westwood, Kansas, 66205

    Joseph McGuirk, DO, jmcguirk@kumc.edu

    Joseph McGuirk, DO

    Recruiting

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

    Withdrawn

  • University of Massachusetts

    Worcester, Massachusetts, 01655

    Active, not recruiting

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

    Terminated

Other trials in United States

About this study

Official title: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Read the detailed description

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Primary Objective:

The primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

  • Assess incidence of transmission of infection
  • Assess incidence of serious infusion reaction
  • Determine 1 year overall survival after cord blood transplantation
  • Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  • Assess cumulative incidence of chronic GVHD
  • Determine platelet engraftment of >20,000 mcL and >50,000 mcL
Being tested
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Disease, Hodgkin Disease, Lymphoma, Non-Hodgkin, Autoimmune Diseases

What participants receive

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

  • A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)Drug

    A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Study groups in NCT01351545
Study groupRoleWhat they receive
Unlicensed CBUThe cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Receives: Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

What is being measured

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

  1. Neutrophil recovery of ≥500/mm3 after cord blood transplantation

    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.

    Measured: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.

  2. Neutrophil recovery of ≥500/mm3 after cord blood transplantation

    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.

    Measured: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.

Timeline

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

  1. First posted11 May 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2041 (estimated)
  4. Study completionOct 2041 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
99,999 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01351545
Sponsor's protocol ID
10-CBA
Status last verified
Feb 2026
First submitted
9 May 2011
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancies and Inherited Disorders of Metabolism, run by Center for International Blood and Marrow Transplant Research at 142 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 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.

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 Elizabeth Fosberg, B.A. (10-CBA@ndmp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neutrophil recovery of ≥500/mm3 after cord blood transplantation (time frame: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.). The study lists 2 primary outcomes in all. 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 NCT01351545.

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 6 Jul 2026.

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