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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01351545
First received: May 9, 2011
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hematologic Malignancies
Certain:
Inherited Disorders of Metabolism
Inherited Abnormalities of Erythrocyte Differentiation or Function
Inherited Abnormalities of Platelets
Disorders of the Immune System
Histiocytic Disorders
X-linked Adrenoleukodystrophy
Primary Immunodeficiency Diseases
Bone Marrow Failure
Beta-thalassemia
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Estimated Enrollment: 99999
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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

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 aim 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 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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are receiving only licensed CBUs
  • Cord blood transplant recipients at international transplant centers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351545

Contacts
Contact: Lexi Adams 612-884-8735 aadams@nmdp.org
Contact: Mandi Proue 612-617-8395 mproue@nmdp.org

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Joseph Chewning, MD       jchewning@peds.uab.edu   
Principal Investigator: Joseph Chewning, MD         
United States, Arizona
Mayo Clinic Arizona (adults) Recruiting
Phoenix, Arizona, United States, 85054
Contact: James Slack, MD       slack.james@mayo.edu   
Principal Investigator: James Slack, MD         
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Roberta Adams, MD       adams.roberta@mayo.edu   
Principal Investigator: Roberta Adams, MD         
Scottsdale Healthcare/Cancer Transplant Institute at Virginia G. Piper Cancer Center Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Jeffrey Schriber, MD    480-323-1392    JSchriber@shc.org   
Contact: Gail Sulski    (480) 323-1393    GSulski@SHC.org   
Principal Investigator: Jeffrey Schriber, MD         
University of Arizona Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85224
Contact: Andrew Yeager, MD       Ayeager@azcc.arizona.edu   
Principal Investigator: Andrew Yeager, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Chatchada Karanes, MD       ckaranes@coh.org   
Principal Investigator: Chatchada Karanes, MD         
Children's Hospital of Los Angeles Recruiting
Glendale, California, United States, 91204
Contact: Neena Kapoor, MD       nkapoor@chla.usc.edu   
Principal Investigator: Neena Kapoor, MD         
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Edward Ball, MD    858-822-6600    tball@ucsd.edu   
Contact: Sue Corringham, RN    858-822-6387    scorringham@ucsd.edu   
Principal Investigator: Edward Ball, MD         
Scripps Green Hospital Recruiting
LaJolla, California, United States, 92037
Contact: Jeffrey W Andrey, MD       andrey.jeffrey@scrippshealth.org   
Principal Investigator: Jeffrey W Andrey, MD         
Loma Linda University Cancer Center Recruiting
Loma Linda, California, United States, 92350
Contact: Joan D Morris, MG       jdmorris@llu.edu   
Principal Investigator: Joan D Morris, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Gary Schiller, MD    310-206-5755    gschiller@mednet.ucla.edu   
Contact: Shirley Fischer    310-794-3019    sfischer@mednet.ucla.edu   
Principal Investigator: Gary Schiller, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Michael Lill, MD       lillm@cshs.org   
Principal Investigator: Michael Lill, MD         
Children's Hospital and Research Center of Oakland Recruiting
Oakland, California, United States, 94609
Contact: Mark Walters, MD       mwalters@mail.cho.org   
Principal Investigator: Mark Walters, MD         
Children's Hospital of Orange County (CHOC) Recruiting
Orange, California, United States, 92868
Contact: Steven Neudorf, MD       sneudorf@choc.org   
Principal Investigator: Steven Neidorf, MD         
Sutter Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Michael Carroll, MD       carrolmp@sutterhealth.org   
Principal Investigator: Michael Carroll, MD         
UC Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Carol Richman, MD    916-734-3772    carol.richman@ucdmc.ucdavis.edu   
Contact: Deborah Stewart    (916) 734-4384    deborahi.stewart@ucdmc.ucdavis.edu   
Principal Investigator: Carol Richman, MD         
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Eric Anderson, MD       eanderson@rchsd.org   
Principal Investigator: Eric Anderson, MD         
UCSF (adults) Recruiting
San Francisco, California, United States, 94143
Contact: Thomas Martin, MD    415-353-9365    tmartin@medicine.ucsf.edu   
Contact: Lisa Dunn    415-353-3220    Lisa.Dunn@ucsfmedctr.org   
Principal Investigator: Thomas Martin, MD         
UCSF (peds) Recruiting
San Francisco, California, United States, 94143
Contact: Chris Dvorak, MD       Dvorakc@peds.ucsf.edu   
Principal Investigator: Chris Dvorak, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94304
Contact: Sandhya Kharbanda, MD       ksandhya@stanford.edu   
Principal Investigator: Sandhya Kharbanda, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Jonathan Gutman, MD       jonathan.gutman@ucdenver.edu   
Principal Investigator: Jonathan Gutman, MD         
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Ralph Quinones, MD       Quinones.Ralph@tchden.org   
Principal Investigator: Ralph Quinones, MD         
Presbyterian St. Luke's/Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Peter McSweeney, MD       peter.mcsweeney@healthonecares.com   
Principal Investigator: Peter McSweeney, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: S. Deborah Chirnomas, MD, MPH       deborah.chirnomas@yale.edu   
Contact: Moira Whitley       moira.whitley@yale.edu   
Principal Investigator: S. Deborah Chirnomas, MD, MPH         
United States, Delaware
Nemours - Alfred I. duPont Hospital for Children Recruiting
Brandywine, Delaware, United States, 19803
Contact: E. Anders Kolb, MD       eakolb@nemours.org   
Principal Investigator: E. Anders Kolb, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington DC, District of Columbia, United States, 20010
Contact: David Jacobsohn, MD       dajacobs@childrensnational.org   
Principal Investigator: David Jacobsohn, MD         
United States, Florida
University of Florida Shands Medical Center Recruiting
Gainesville, Florida, United States, 32610
Contact: John R Wingard, MD    352-273-8022    wingajr@ufl.edu   
Contact: Joe Stokes, RN, BS    352-273-6845    Joe.stokes@medicine.ufl.edu   
Principal Investigator: John R Wingard, MD         
Mayo Clinic - Jacksonville (adults) Recruiting
Jacksonville, Florida, United States, 32224
Contact: Vivek Roy, MD       roy.vivek@mayo.edu   
Principal Investigator: Vivek Roy, MD         
Nemours Children's Hospital - Mayo Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Michael Joyce, MD       mjoyce@nemours.org   
Principal Investigator: Michael Joyce, MD         
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
Contact: Guillermo De Angulo, MD    786-624-3829    Guillermo.DeAngulo@mch.com   
Principal Investigator: Kamar Godder, MD         
University of Miami (adult) Recruiting
Miami, Florida, United States, 33136
Contact: Krishna Komanduri, MD    305-243-6355      
Principal Investigator: Krishna Komanduri, MD         
University of Miami (peds) Recruiting
Miami, Florida, United States, 33136
Contact: Martin Andreansky, MD       mandreansky@med.maimi.edu   
Principal Investigator: Martin Andreansky, MD         
Florida Hospital Cancer Institute Terminated
Orlando, Florida, United States, 32804
Florida Center for Cellular Therapy (adults only) Recruiting
Orlando, Florida, United States, 32804
Contact: Melhem Solh, MD       melhem.solh.md@flhosp.org   
Principal Investigator: Melhem Solh, MD         
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Aleksandra Petrovic, MD       Aleksandra.Petrovic@allkids.org   
Principal Investigator: Aleksandra Petrovic, MD         
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Marcie Riches Tomblyn, MD       marcie.tomblyn@moffitt.org   
Principal Investigator: Marcie Riches Tomblyn, MD         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ann Haight, MD       Ann.haight@choa.org   
Principal Investigator: Ann Haight, MD         
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott Solomon, MD       ssolomon@bmtga.com   
Principal Investigator: Scott Solomon, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD       ewaller@emory.edu   
Principal Investigator: Edmund Waller, MD         
United States, Hawaii
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Randal Wada, MD       randalw@hawaii.edu   
Principal Investigator: Randal Wada, MD         
United States, Illinois
Indiana Blood & Marrow Transplantation Recruiting
Beech Grove, Illinois, United States, 46107
Contact: Luke Akard, MD       lakard@ibmtindy.com   
Principal Investigator: Luke Akard, MD         
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60614
Contact: Reggie Duerst, MD       rduerst@childrensmemorial.org   
Principal Investigator: Reggie Duerst, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Hongtao Liu, MD       hliu2@medicine.bsd.uchicago.edu   
Principal Investigator: Hongtao Liu, MD         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Olga Frankfurt, MD       o-frankfurt@northwestern.edu   
Principal Investigator: Olga Frankfurt, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: John Maciejewski, MD       john_maciejewski@rush.edu   
Principal Investigator: John Maciejewski, MD         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Damiano Rondelli, MD       drond@uic.edu   
Principal Investigator: Damiano Rondelli, MD         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Patrick Stiff, MD       pstiff@lumc.edu   
Principal Investigator: Patrick Stiff, MD         
Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Istvan Redei, MD       Istvan.redei@ctca-hope.com   
Principal Investigator: Istvan Redei, MD         
United States, Indiana
Indiana University Bone Marrow and SCT Program Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sherif Farag, MD       ssfarag@iupui.edu   
Principal Investigator: Sherif Farag, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Margarida Silverman, MD       margarida-silverman@uiowa.edu   
Principal Investigator: Margarida Silverman, MD         
United States, Kansas
University of Kansas Recruiting
Westwood, Kansas, United States, 66205
Contact: Joseph McGuirk, DO       jmcguirk@kumc.edu   
Principal Investigator: Joseph McGuirk, DO         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Zartash Gul, MD       zgu224@uky.edu   
Contact: Nancy Johnson       nkjohn2@uky.edu   
Principal Investigator: Zartash Gul, MD         
University of Louisville Hospital - James Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Cesar Rodriguez, MD       c0rodr04@louisville.edu   
Principal Investigator: Cesar Rodriguez, MD         
United States, Louisiana
Children's Hospital of New Orleans/LSUHSC Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie Yu, MD    504-896-9740    lyu@lsuhsc.edu   
Contact: Margaret Meyers    (504) 896-2818    mmeyers@chnola.org   
Principal Investigator: Lolie Yu, MD         
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Hana Safa, MD       hsafah@tulane.edu   
Principal Investigator: Hana Safa, MD         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Allen Chen, MD, PhD       allenchen@jhmi.edu   
Contact: Duane Herbel       dherbel1@jhmi.edu   
Principal Investigator: Allen Chen, MD, PhD         
Greenebaum Cancer Center - University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Saul Yanovich, MD       syanovich@umm.edu   
Principal Investigator: Saul Yanovich, MD         
NIH/NCI Terminated
Bethesda, Maryland, United States, 20892
Nih/Nhlbi Recruiting
Bethesda, Maryland, United States, 20892
Contact: Richard Childs, MD       childsr@nih.gov   
Principal Investigator: Richard Childs, MD         
Nih/Niaid Recruiting
Bethesda, Maryland, United States, 20892-1456
Contact: Elizabeth Kang, MD       ekang@niaid.nih.gov   
Principal Investigator: Elizabeth Kang, MD         
United States, Massachusetts
Beth Israel Deaconess Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Avigan, MD       davigan@bidmc.harvard.edu   
Principal Investigator: David Avigan, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Karen Ballen, MD       kballen@partners.org   
Principal Investigator: Karen Ballen, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Corey Cutler, MD       cscutler@partners.org   
Principal Investigator: Cory Cutler, MD         
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Andreas Klein, MD    617-636-8884    aklein2@tuftsmedicalcenter.org   
Contact: Jodi Jensen, RN    617-636-5558    jjensen@tuftsmedicalcenter.org   
Principal Investigator: Andreas Klein, MD         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Rajneesh Nath, MC       rajneesh.nath@umassmemorial.org   
Principal Investigator: Rajneesh Nath, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Daniel Couriel, MD       dcouriel@umich.edu   
Principal Investigator: Daniel Couriel, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Nalini Janakiraman, MD       njanaki1@hfhs.org   
Principal Investigator: Nalini Janakiraman, MD         
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Voravit Ratanatharathorn, MD       ratanath@karmanos.org   
Principal Investigator: Voravit Ratanatharathorn, MD         
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Sureyya Savasan, MD       ssavasan@med.wayne.edu   
Principal Investigator: Sureyya Savasan, MD         
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Aly Abdel-Mageed, MD       aly.mageed@helendevoschildrens.org   
Principal Investigator: Aly Abdel-Mageed, MD         
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Aly Abdel-Mageed, MD       aly.mageed@helendevoschildrens.org   
Principal Investigator: Aly Abdel-Mageed, MD         
Univeristy of Mississippi Medical Center Recruiting
Jackson, Michigan, United States, 39216
Contact: Carolyn Bigelow, MD       cbigelow@umc.edu   
Principal Investigator: Carolyn Bigelow, MD         
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: William Hogan, MD       hogan.william@mayo.edu   
Principal Investigator: William Hogan, MD         
United States, Missouri
Children's Mercy Hospital and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Jignesh Dalal, MD       jddalal@cmh.edu   
Principal Investigator: Jignesh Dalal, MD         
Cardinal Glennon Children's Medical Center Recruiting
St. Louis, Missouri, United States, 63104
Contact: Deepika Bhatla, MD       dbhatla@slu.edu   
Principal Investigator: Deepika Bhatla, MD         
Washington University St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Peter Westervelt, MD, PhD       pwesterv@dom.wustl.edu   
Principal Investigator: Peter Westerveldt, MD, PhD         
Washington University/St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Shalini Shenoy, MD       Shenoy@kids.wustl.edu   
Principal Investigator: Shalini Shenoy, MD         
St. Louis University Medical Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sagun Goyal, MD       sgoyal3@slu.edu   
Principal Investigator: Sagun Goyal, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-2168
Contact: Phyllis Warkenton, MD       pwarkent@unmc.edu   
Principal Investigator: Phyllis Warkenton, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Alfred Gillio, MD       agillio@humed.com   
Principal Investigator: Alfred Gillio, MD         
Robert Wood Johnson/Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Roger Strair, MD, PhD       strairrk@umdnj.edu   
Principal Investigator: Roger Strair, MD, PhD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Philip McCarthy, MD       philip.mccarthy@roswellpark.org   
Principal Investigator: Philip McCarthy, MD         
North Shore University Hospital Recruiting
Lake Sucess, New York, United States, 11042
Contact: Ruthee L Bayer, MD       rbayer@nshs.edu   
Principal Investigator: Ruthee L Bayer, MD         
Cohen Children's Medical Center of New York Recruiting
New Hyde, New York, United States, 11040
Contact: Joel Brochstein, MD       jbrochstein@nshs.edu   
Principal Investigator: Joel Brochstein, MD         
New York Medical College Recruiting
New York, New York, United States, 10595
Contact: Mitchell Cairo, MD    914-594-3640    mitchell_cairo@nymc.edu   
Principal Investigator: Mitchell Cairo, MD         
New York Presbyterian Hospital at Cornell Recruiting
New York, New York, United States, 10021
Contact: Tsiporah Shore, MD       tbs2001@med.cornell.edu   
Principal Investigator: Tsiporah Shore, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Juliet Barker, MBBS       barkerj@mskcc.org   
Principal Investigator: Juliet Barker, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Luis Isola, MD       luis.isola@mountsinai.org   
Principal Investigator: Luis Isola, MD         
Columbia University Medical Center - Morgan Stanley Children's Hospital Recruiting
New York, New York, United States, 10032
Contact: Monica Bhatia, MD       mb2476@columbia.edu   
Principal Investigator: Monica Bhatia, MD         
Strong Memorial Hospital/University of Rochester Recruiting
Rochester, New York, United States, 14642-8704
Contact: Jane Liesveld, MD       jane_liesveld@urmc.rochester.edu   
Principal Investigator: Jane Liesveld, MD         
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
Contact: Michael Schuster, MD       mschuster@notes.cc.sunysb.edu   
Principal Investigator: Michael Schuster, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kimberly Kasow, DO       kkasow@med.unc.edu   
Principal Investigator: Kimberly Kasow, DO         
Duke University Medical Center (peds) Recruiting
Durham, North Carolina, United States, 22705
Contact: Joanne Kurtzberg, MD       kurtz001@mc.duke.edu   
Principal Investigator: Joanne Kurtzberg, MD         
Duke Universoty Medical Center (adults) Recruiting
Durham, North Carolina, United States, 27705
Contact: Joanne Kurtzberg, MD       kurtz001@mc.duke.edu   
Principal Investigator: Joanne Kurtzberg, MD         
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: David Hurd, MD       dhurd@wakehealth.edu   
Principal Investigator: David Hurd, MD         
United States, Ohio
Childrens Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven Kuerbitz, MD       skuerbitz@chmca.org   
Principal Investigator: Steven Kuerbitz@chmca.org, MD         
The Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45230
Contact: E. Randolph Broun, MD       erbroun@ohcmail.com   
Principal Investigator: E. Randolph Broun, MD         
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sonata Jodele, MD       sonata.jodele@cchmc.org   
Principal Investigator: Sonata Jodele, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Hillard Lazarus, MD       hillard.lazarus@case.edu   
Principal Investigator: Hillard Lazarus, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Matt Kalaycio, MD       kalaycm@ccf.org   
Principal Investigator: Matt Kalaycio, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Jeffery Auletta, MD       jeffery.auletta@nationwidechildrens.org   
Principal Investigator: Jeffery Auletta, MD         
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Steven Devine, MD       Steven.devine@osumc.edu   
Principal Investigator: Steven Devine, MD         
United States, Oklahoma
University of Oklahoma Health Science Center Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: George Selby, MD       George-selby@ouhsc.edu   
Principal Investigator: George Selby, MD         
United States, Oregon
Oregon Health & Science University/Doernbecher Children's Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Eneida Nemecek, MD       nemeceke@ohsu.edu   
Principal Investigator: Eneida Nemecek, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Cancer Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Witold Rybka, MD       wrybka@hmc.psu.edu   
Principal Investigator: Witold Rybka, MD         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nancy Bunin, MD       buninn@email.chop.edu   
Principal Investigator: Nancy Bunin, MD         
University of Pennsylvania/Thomas Jefferson Recruiting
Pittsburg, Pennsylvania, United States, 19104
Contact: Elizabeth Hexner, MD       elizabeth.hexner@uphs.upenn.edu   
Principal Investigator: Elizabeth Hexner, MD         
Western Penn Hospital Recruiting
Pittsburg, Pennsylvania, United States, 15224
Contact: John Lister, MD       Jlister@wpahs.org   
Principal Investigator: John Lister, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Mounzer Agha, MD       aghame@upmc.edu   
Contact: Ann Welsch       welshah2@upmc.edu   
Principal Investigator: Mounzer Agha, MD         
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Rakesh Goyal, MD       rakesh.goyal@chp.edu   
Principal Investigator: Rakesh Goyal, MD         
United States, Rhode Island
Roger Williams Medical Center Recruiting
Providence, Rhode Island, United States, 02908
Contact: Todd Roberts, MD       todd.roberts@chartercare.org   
Contact: Elise Ferrara       eferrara@chartercare.org   
Principal Investigator: Todd Roberts, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robert Stuart, MD    843-792-4271    stuartrk@musc.edu   
Contact: Jessica Simons    843-792-8856    simonsjl@musc.edu   
Principal Investigator: Robert Stuart, MD         
United States, South Dakota
Avera Transplant Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Ramakrishnan Parameswaran, MD       vinod.parameswaran@avera.org   
Principal Investigator: Ramakrishnan Parameswaran, MD         
United States, Tennessee
St. Jude Childrens Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Mari Hashitate Dallas, MD       Mari.Dallas@STJUDE.ORG   
Principal Investigator: Mari Hashitate Dallas, MD         
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Haydar Frangoul, MD    615-939-1762    Haydar.frangoul@vanderbilt.edu   
Contact: Jessica Piggee, MPH    615-875-6120    Jessica.l.piggee@vanderbilt.edu   
Principal Investigator: Haydar Frangoul, MD         
VA Tennessee Valley Healthcare System Terminated
Nashville, Tennessee, United States, 37212
United States, Texas
Amarillo Blood and Marrow Transplant Program Terminated
Amarillo, Texas, United States, 79106
Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Vikas Bhushan, MD       vikas.bhushan@usoncology.com   
Principal Investigator: Vikas Bhushan, MD         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Edward Agura, MD       edward.agura@baylorhealth.edu   
Principal Investigator: Edward Agura, MD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Madhuri Vusirikala, MD       madhuri.vusirikala@utsouthwestern.edu   
Principal Investigator: Madhuri Vusirikala, MD         
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Victor Aquino, MD       Victor.aquino@utsouthwestern.edu   
Principal Investigator: Victor Aquino, MD         
Cook Children's Hospital Recruiting
Fort Worth, Texas, United States, 76104
Contact: Gretchen Eames, MD       gretchen.eames@cookchildrens.org   
Principal Investigator: Gretchen Eames, MD         
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth Shpall, MD       eshpall@mdanderson.org   
Principal Investigator: Elizabeth Shpall, MD         
Texas Children's Hospital - Baylor Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Robert Krance, MD    832-824-4661    rakrance@txch.org   
Contact: Marlin Dinu    832-824-4881    mxdinu@txch.org   
Principal Investigator: Robert Krance, MD         
Southwest Cancer Treatment & Research Center Recruiting
Lubbock, Texas, United States, 79415
Contact: Everardo Cobos, MD       everardo.cobos@ttuhsc.edu   
Principal Investigator: Everardo Cobos, MD         
Methodist Healthcare System of San Antonio/Texas Transplant Institute Recruiting
San Antonio, Texas, United States, 78229
Contact: Carlos Bachier, MD       carlos.bachier@mhshealth.com   
Principal Investigator: Carlos Bachier, MD         
United States, Utah
Intermountain Blood and Marrow Transplant Program Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Finn Bo Petersen, MD       finn.petersen@imail.org   
Principal Investigator: Finn Bo Petersen, MD         
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Michael Boyer, MD       michael.boyer@hsc.utah.edu   
Principal Investigator: Michael Boyer, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Tammy Kindwall-Keller, MD       tlk5de@virginia.edu   
Principal Investigator: Tammy Kindwall-Keller, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23227
Contact: John McCarty, MD    804-828-4596    jmccarty@vcu.edu   
Contact: Kathy Candler    804-828-7432    kcandler@vcu.edu   
Principal Investigator: John McCarty, MD         
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Ann Woolfrey, MD       awoolfre@fhcrc.org   
Principal Investigator: Ann Woolfrey, MD         
VA Puget Sound HCS Recruiting
Seattle, Washington, United States, 98108
Contact: Thomas Chauncey, MD       Thomas.Chauncey@va.gov   
Principal Investigator: Thomas Chauncey, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506-8110
Contact: Michael Craig, MD       craigm@wvuhealthcare.com   
Principal Investigator: Michael Craig, MD         
United States, Wisconsin
University of Wisconsin - Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Walter Longo, MD       wll@medicine.wisc.edu   
Principal Investigator: Walter Longo, MD         
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: David Margolis, MD       dmargoli@mcw.edu   
Principal Investigator: David Margolis, MD         
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Parameswaran Hari, MD    414-805-4600    phari@mcw.edu   
Contact: Leigh Ann Laczkowski    414-805-8378    llaczkow@mcw.edu   
Principal Investigator: Parameswaran Hari, MD         
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
Study Chair: John Miller, MD, PhD NMDP/CIBMTR
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01351545     History of Changes
Other Study ID Numbers: 10-CBA
Study First Received: May 9, 2011
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Beta-Thalassemia
Neoplasms
Immunologic Deficiency Syndromes
Pancytopenia
Thalassemia
Adrenoleukodystrophy
Hematologic Neoplasms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Immune System Diseases
Hereditary Central Nervous System Demyelinating Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Peroxisomal Disorders
Leukoencephalopathies
Demyelinating Diseases
Mental Retardation, X-Linked
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System

ClinicalTrials.gov processed this record on July 22, 2014