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

This study is currently recruiting participants.
Verified April 2013 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: April 23, 2013
Last verified: April 2013
History of Changes
  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
Hematological Malignancies
Certain Lysosomal Storage and Peroxisomal Enzyme Deficiency Disorders
Hurler Syndrome (MPS I)
Krabbe Disease (Globoid Leukodystrophy)
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:

U.S. FDA Resources

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 graft rejection
  • 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
  • Determine CBU-derived engraftment
  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:

  • Patients with FDA-specified indications: Hematological malignancies, Certain lysosomal storage and peroxisomal enzyme deficiency disorders (Hurler syndrome (MPS I), Krabbe Disease (Globoid Leukodystrophy),and X-linked Adrenoleukodystrophy), Primary immunodeficiency diseases, Bone marrow failure, and Beta-thalassemia
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351545

  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 Universoty 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: Carolynn Richman, MD     916-734-3772     carol.richman@ucdmc.ucdavis.edu    
Contact: Deborah Stewart     (916) 734-4384     deborahi.stewart@ucdmc.ucdavis.edu    
Principal Investigator: Carolynn 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 Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: S. Deborah Chirnomas, MD, MPH         deborah.chirnomas@yale.edu    
Contact: Joanna Hilburn         joanna.hilburn@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 Active, not recruiting
Miami, Florida, United States, 33155
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
Contact: Martin Andreansky, MD         mandreansky@med.maimi.edu    
Principal Investigator: Martin Andreansky, MD            
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Melhem Solh, MD         melhem.solh.md@flhosp.org    
Principal Investigator: Melhem Sohl, MD            
Florida Center for Cellular Therapy 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 Tomblyn, MD         marcie.tomblyn@moffitt.org    
Principal Investigator: Marcie 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         tbear@cc.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            
Children's Memorial Hospital 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
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: Henry Fung, MD         henry_fung@rush.edu    
Principal Investigator: Henry Fung, MD            
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States
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 Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Dianna Howard, MD         dshowa0@email.uky.edu    
Principal Investigator: Dianna Howard, MD            
University of Louisville Hospital - James Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Herzig, MD         herzig@louisville.edu    
Principal Investigator: Robert Herzig, 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            
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: WWilliam 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            
St. Louis University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sagun Goyal, MD         sgoyal3@slu.edu    
Principal Investigator: Steven Pincus, MD, PhD            
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            
St. Louis Children's Recruiting
St. Louis, Missouri, United States, 63110
Contact: Shalini Shenoy, MD         Shenoy@kids.wustl.edu    
Principal Investigator: Shalini Shenoy, 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            
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 Active, not recruiting
New Brunswick, New Jersey, United States, 08901
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 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            
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            
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            
Levine Children's Hospital/Carolinas Medical Center Not yet recruiting
Charlotte, North Carolina, United States
Contact: Howard Grodman, MD         howard.grodman@carolinashealthcare.org    
Principal Investigator: Howard Grodman, MD            
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            
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sonata Jodele, MD         sonata.jodele@cchmc.org    
Principal Investigator: Sonata Jodele, MD            
The Jewish Hospital Recruiting
Cincinnati, Ohio, United States, 45230
Contact: E. Randolph Broun, MD         erbroun@ohcmail.com    
Principal Investigator: E. Randolph Broun, MD            
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Matt Kalaycio, MD         kalaycm@ccf.org    
Principal Investigator: Matt Kalaycio, 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            
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            
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Sandeep Soni, MD         sandeep.soni@nationwidechildrens.org    
Principal Investigator: Sandeep Soni, 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            
West 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 Terminated
Providence, Rhode Island, United States, 02908
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            
Vanderbilt Veterans Hospital Recruiting
Nashville, Tennessee, United States, 37212
Contact: Wichai Chinratanalab, MD     615-873-6373     Wichai.Chinratanalab@va.gov    
Contact: Rita Lynch     615-873-6373     rita.lynch@va.gov    
Principal Investigator: Wichai Chinratanalab, MD            
United States, Texas
Amarillo Blood and Marrow Transplant Program Recruiting
Amarillo, Texas, United States, 79106
Contact: Seah Lim, MD         seah.lim@usoncology.com    
Principal Investigator: Seah Lim, MD            
Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Robert B Berryman, MD         Robert.berryman@usoncology.com    
Principal Investigator: Robert B Berryman, MD            
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Edward Agura, MD         edward.agura@baylorhealth.edu    
Principal Investigator: Edward Agura, 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            
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            
Zachary and Elizabeth M Fisher Bome Marrow Transplant Unit Not yet recruiting
Fork Sam Houston, Texas, United States, 78234-6200
Contact: Michael Osswald, MD         michael.osswald@amedd.army.mil    
Principal Investigator: Michael Osswald, 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            
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 Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Mary J Laughlin, MD         mjl5g@virginia.edu    
Principal Investigator: Mary J Laughlin, 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
Seattle Cancer Care Alliance 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
  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: April 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Beta-Thalassemia
Neoplasms
Leukodystrophy, Globoid Cell
Immunologic Deficiency Syndromes
Pancytopenia
Thalassemia
Mucopolysaccharidosis I
Adrenoleukodystrophy
Hematologic Neoplasms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Hereditary Central Nervous System Demyelinating Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Leukoencephalopathies
Demyelinating Diseases
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013