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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Center for International Blood and Marrow Transplant Research
Study ID
NCT01351545
Status
Recruiting

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML or ANLL)
  • Autoimmune Diseases
  • Chronic Myelogenous Leukemia (CML)
  • Disorders of the Immune System
  • Hematologic Malignancies
  • Histiocytic Disorders
  • Hodgkin Lymphoma
  • Inherited Abnormalities of Erythrocyte Differentiation or Function
  • Inherited Abnormalities of Platelets
  • Inherited Disorders of Metabolism
  • Multiple Myeloma/ Plasma Cell Disorder (PCD)
  • Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
  • Non-hodgkin Lymphoma
  • Other Acute Leukemia
  • Other Leukemia
  • Severe Aplastic Anemia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Feb 2026
Primary completion
Oct 31, 2041
Completion
Oct 31, 2041

Study Design

Enrollment
99,999 participants (estimated)

Arms

  • Arm: Unlicensed CBU
    The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.

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. ]

Central Contacts

Locations (142)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Joseph Chewning, MD
Joseph Chewning, MD (PRINCIPAL_INVESTIGATOR)
Banner MD Anderson Cancer CenterGilbertArizona85234
Matthew Ulrickson, MD
480-256-3223
Matthew Ulrickson, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Arizona (adults)PhoenixArizona85054-
Phoenix Children's HospitalPhoenixArizona85016
Dana Salzberg, MD
602-546-0920
Dana Salzberg, MD (PRINCIPAL_INVESTIGATOR)
University of Arizona Medical Center - TucsonTucsonArizona85224
Emmanuel Katsanis, MD
Emmanuel Katsanis, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's HospitalLittle RockArkansas72202
Jason Farrar, MD
City of HopeDuarteCalifornia91010
Monzr Al Malki, MD
Monzr Al Malki, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Los AngelesGlendaleCalifornia91204
Neena Kapoor, MD
Neena Kapoor, MD (PRINCIPAL_INVESTIGATOR)
Scripps Green HospitalLa JollaCalifornia92037
James R Mason, MD
James R Mason, MD (PRINCIPAL_INVESTIGATOR)
University of California San DiegoLa JollaCalifornia92093
Kaitlyn Dykes, MD
8588226600
Kaitlyn Dykes, MD (PRINCIPAL_INVESTIGATOR)
Loma Linda University Cancer CenterLoma LindaCalifornia92350
Hisham Abdel-Azim, MD
Hisham Abdel-Azim, MD (PRINCIPAL_INVESTIGATOR)
UCLALos AngelesCalifornia90095
Gary Schiller, MD
310-206-5755
Gary Schiller, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital and Research Center of OaklandOaklandCalifornia94609-
Children's Hospital of Orange County (CHOC)OrangeCalifornia92868
Rishikesh Chavan, MD
Rishikesh Chavan, MD (PRINCIPAL_INVESTIGATOR)
Sutter Medical CenterSacramentoCalifornia95816
Elias Kiwan, MD
(916) 733-4400
Elias Kiwan, MD (PRINCIPAL_INVESTIGATOR)
Rady Children's Hospital San DiegoSan DiegoCalifornia92123
Eric Anderson, MD
Eric Anderson, MD (PRINCIPAL_INVESTIGATOR)
UCSF (adults)San FranciscoCalifornia94143-
UCSF (Peds)San FranciscoCalifornia94143
Sandhya Kharbanda, MD
Sandhya Kharbanda, MD (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterStanfordCalifornia94304
Andrew Rezvani, MD
Andrew Rezvani, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Michael Verneris, MD
Michael Verneris, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado HospitalAuroraColorado80045
Jonathan Gutman, MD
Jonathan Gutman, MD (PRINCIPAL_INVESTIGATOR)
Presbyterian St. Luke's/Colorado Blood Cancer InstituteDenverColorado80218
Alireza Eghtedar, MD
Alireza Eghtedar, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06510
Aaron Flagg, MD
Aaron Flagg, MD (PRINCIPAL_INVESTIGATOR)
Nemours - Alfred I. duPont Hospital for ChildrenBrandywineDelaware19803
Emi Caywood, MD
Emi Caywood, MD (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
David Jacobsohn, MD
David Jacobsohn, MD (PRINCIPAL_INVESTIGATOR)
University of Florida Shands Medical CenterGainesvilleFlorida32610
Jordan Milner, MD
352-273-9120
Jordan Milner, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Nemours Children's Hospital - Mayo JacksonvilleJacksonvilleFlorida32207
Edward Ziga, MD
904-697-2047
Edward Ziga, MD (PRINCIPAL_INVESTIGATOR)
Niklaus Children's HospitalMiamiFlorida33155
Jorge Galvez-Silva, MD
Jorge Galvez-Silva, MD (PRINCIPAL_INVESTIGATOR)
University of Miami (adult)MiamiFlorida33136-
University of Miami (peds)MiamiFlorida33136
Edward Ziga, MD, MPH
Edward Ziga, MD, MPH (PRINCIPAL_INVESTIGATOR)
AdventHealth OrlandoOrlandoFlorida32804
Rushang Patel, MD
Rushang Patel, MD (PRINCIPAL_INVESTIGATOR)
Florida Center for Pediatric Cellular TherapyOrlandoFlorida32804
Susan Kelly, MD
Susan Kelly, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health Arnold Palmer Hospital for ChildrenOrlandoFlorida32806
Rikin Shah
321-842-9904
Rikin Shah, MD (PRINCIPAL_INVESTIGATOR)
Orlando Health Cancer Institute Bone Marrow Transplant and Cellular TherapyOrlandoFlorida32806
Yasser Khaled, MD
Yasser Khaled, MD (PRINCIPAL_INVESTIGATOR)
All Children's HospitalSt. PetersburgFlorida33701
Deepakbabu Chellapandian, MD
Deepakbabu Chellapandian, MD (PRINCIPAL_INVESTIGATOR)
H Lee Moffitt Cancer CenterTampaFlorida33612-
Children's Healthcare of AtlantaAtlantaGeorgia30322
Ann Haight, MD
Ann Haight, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322-
Northside HospitalAtlantaGeorgia30342
Scott Solomon, MD
Scott Solomon, MD (PRINCIPAL_INVESTIGATOR)
Georgia Cancer Center at Augusta University HealthAugustaGeorgia30912
Vamsi K Kota, MD
Vamsi K Kota, MD (PRINCIPAL_INVESTIGATOR)
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96813
Randal Wada, MD
Randal Wada, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60614
Sonali Chaudhury, MD
Sonali Chaudhury, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Kehinde Adekola, MD
Kehinde Adekola, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Sunita Nathan, MD
Sunita Nathan, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
James LaBelle, MD, PhD
James LaBelle, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
Damiano Rondelli, MD
Damiano Rondelli, MD (PRINCIPAL_INVESTIGATOR)
Loyola University Medical CenterMaywoodIllinois60153
Patrick Hagen, MD
Patrick Hagen, MD (PRINCIPAL_INVESTIGATOR)
Advocate Lutheran General HospitalPark RidgeIllinois60068-
Midwestern Regional Medical CenterZionIllinois60099-
Indiana Blood & Marrow TransplantationBeech GroveIndiana46107-
Indiana University/Riley Hospital for ChildrenIndianapolisIndiana46202
Jodi Skiles, MD
Jodi Skiles, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Margarida Silverman, MD
Margarida Silverman, MD (PRINCIPAL_INVESTIGATOR)
University of KansasWestwoodKansas66205
Joseph McGuirk, DO
Joseph McGuirk, DO (PRINCIPAL_INVESTIGATOR)
University of Louisville Hospital - James Brown Cancer CenterLouisvilleKentucky40202
Mohamed Hegazi, MD
Mohamed Hegazi, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of New Orleans/LSUHSCNew OrleansLouisiana70118
Lolie Yu, MD
(504) 896-9740
Lolie Yu, MD (PRINCIPAL_INVESTIGATOR)
Tulane Medical CenterNew OrleansLouisiana70112-
Greenebaum Cancer Center - University of MarylandBaltimoreMaryland21201-
Johns HopkinsBaltimoreMaryland21287
Allen Chen, MD, PhD
Allen Chen, MD, PhD (PRINCIPAL_INVESTIGATOR)
NIH/NCIBethesdaMaryland20892-
Nih/NhlbiBethesdaMaryland20892
Richard Childs, MD
Richard Childs, MD (PRINCIPAL_INVESTIGATOR)
Nih/NiaidBethesdaMaryland20892-1456
Elizabeth Kang, MD
Elizabeth Kang, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel DeaconessBostonMassachusetts02215
David Avigan, MD
David Avigan, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Corey Cutler, MD
Cory Cutler, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111
Andreas Klein, MD
617-636-8884
Andreas Klein, MD (PRINCIPAL_INVESTIGATOR)
University of MassachusettsWorcesterMassachusetts01655-
University of MichiganAnn ArborMichigan48109
Gregory Yanik, M.D. (PRINCIPAL_INVESTIGATOR)
Children's Hospital of MichiganDetroitMichigan48201
Sureyya Savasan, MD
Sureyya Savasan, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Nalini Janakiraman, MD
Nalini Janakiraman, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201-
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Troy Quigg, MD
Troy Quigg, MD (PRINCIPAL_INVESTIGATOR)
Spectrum HealthGrand RapidsMichigan49503
Aly Abdel-Mageed, MD
Aly Abdel-Mageed, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905-
Univeristy of Mississippi Medical CenterJacksonMississippi39216
Carter Milner, MD
601-984-5613
Carter Milner, MD (PRINCIPAL_INVESTIGATOR)
Children's Mercy Hospital and ClinicsKansas CityMissouri64108
Erin Hall, MD
816-302-6808
Erin Hall, MD (PRINCIPAL_INVESTIGATOR)
Cardinal Glennon Children's Medical CenterSt LouisMissouri63104
Deepika Bhatla, MD
Deepika Bhatla, MD (PRINCIPAL_INVESTIGATOR)
St. Louis University Medical CenterSt LouisMissouri63110-
Washington University St. LouisSt LouisMissouri63110
Geoffrey Uy, MD
Geoffrey Uy, MD (PRINCIPAL_INVESTIGATOR)
Washington University/St. Louis Children's HospitalSt LouisMissouri63110
Geoffrey Uy, MD
Geoffrey Uy, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198-2168
Phyllis Warkenton, MD
Phyllis Warkenton, MD (PRINCIPAL_INVESTIGATOR)
Hackensack University Medical CenterHackensackNew Jersey07601
Alfred Gillio, MD
Alfred Gillio, MD (PRINCIPAL_INVESTIGATOR)
Robert Wood Johnson/Cancer Institute of New JerseyNew BrunswickNew Jersey08901
Matthew Matasar, MD, MS
Matthew Matasar, MD, MS (PRINCIPAL_INVESTIGATOR)
Roswell Park Cancer InstituteBuffaloNew York14263
Kanwaldeep Mallhi, MD
(716) 845-2333
Kanwaldeep Mallhi, MD (PRINCIPAL_INVESTIGATOR)
North Shore University HospitalLake SucessNew York11042
Ruthee L Bayer, MD
Ruthee L Bayer, MD (PRINCIPAL_INVESTIGATOR)
Cohen Children's Medical Center of New YorkNew HydeNew York11040
Jonathan Fish, MD
Jonathan Fish, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center - Morgan Stanley Children's HospitalNew YorkNew York10032
Monica Bhatia, MD
Monica Bhatia, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065
Ann Jakubowski, MD
646-752-5174
Ann Jakubowski, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical Center - New YorkNew YorkNew York10029
Alla Keyzner, MD
Alla Keyzner, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital at CornellNew YorkNew York10021
Tsiporah Shore, MD
Tsiporah Shore, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone Medical CenterNew YorkNew York10016
Mohammad M Abdul Hay, MD
312-315-2687
Antoine Mesidor
Mohammad M Abdul Hay, MD (PRINCIPAL_INVESTIGATOR)
Westchester Medical CenterNew YorkNew York10595
Mitchell Cairo, MD
914-594-3640
Mitchell Cairo, MD (PRINCIPAL_INVESTIGATOR)
Strong Memorial Hospital/University of RochesterRochesterNew York14642-8704
Omar Aljitawi, MD
Omar Aljitawi, MD (PRINCIPAL_INVESTIGATOR)
Stony Brook University HospitalStony BrookNew York11794
Michael Schuster, MD
Michael Schuster, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital at MontefioreThe BronxNew York10467
Mahvish Rahim, MD
David Loeb, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Anson Snow, MD
984-974-1000
Anson Snow, MD (PRINCIPAL_INVESTIGATOR)
Levine Children's HospitalCharlotteNorth Carolina28203
Jeffrey Huo, MD
Michelle Hyland
Jeffrey Huo, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27705
Joanne Kurtzberg, MD
Joanne Kurtzberg, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest UniversityWinston-SalemNorth Carolina27157-
Childrens Hospital Medical Center of AkronAkronOhio44308
Megan Sampson, MD
Megan Sampson, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's HospitalCincinnatiOhio45229
Stella Davies, MD
Stella Davies, MD (PRINCIPAL_INVESTIGATOR)
The Jewish HospitalCincinnatiOhio45230-
Cleveland ClinicClevelandOhio44195
Claudio Brunstein, MD
(216) 445-0910
Claudio Brunstein, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Case Medical CenterClevelandOhio44106
Hillard Lazarus, MD
Hillard Lazarus, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Rolla Abu-Arja, MD
Rolla Abu-Arja, MD (PRINCIPAL_INVESTIGATOR)
The Arthur G. James Cancer Hospital/The Ohio State University Medical CenterColumbusOhio43210
Sumithira Vasu, MD
Sumithira Vasu, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Science CenterOklahoma CityOklahoma73103
Adam Asch, MD
Adam Asch, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science University/Doernbecher Children's HospitalPortlandOregon97239
Eneida Nemecek, MD
Eneida Nemecek, MD (PRINCIPAL_INVESTIGATOR)
Penn State Milton S. Hershey Cancer CenterHersheyPennsylvania17033
Shin Mineishi, MD
Shin Mineishi, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Timothy Olson, MD
267-426-5516
Timothy Olson, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PittsburghPittsburghPennsylvania15224
Paul Szabolcs, MD
Paul Szabolcs, MD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania/Thomas JeffersonPittsburghPennsylvania19104
Elizabeth Hexner, MD
Elizabeth Hexner, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Alison Sehgal, MD
Alison Sehgal, MD (PRINCIPAL_INVESTIGATOR)
West Penn HospitalPittsburghPennsylvania15224
Prerna Mewawalla, MD
412-578-4484
Prerna Mewawalla, MD (PRINCIPAL_INVESTIGATOR)
Roger Williams Medical CenterProvidenceRhode Island02908-
Medical University of South CarolinaCharlestonSouth Carolina29425
Michelle Hudspeth, MD
843-792-2957
Michelle Hudspeth, MD (PRINCIPAL_INVESTIGATOR)
Avera Transplant InstituteSioux FallsSouth Dakota57105
Waqas Jehangir, MD, FACP
Waqas Jehangir, MD, FACP (PRINCIPAL_INVESTIGATOR)
Methodist Healthcare Blood and Marrow Transplant CenterMemphisTennessee38104-
St. Jude Childrens Research HospitalMemphisTennessee38105
Renee Madden, MD
Renee Madden, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon BMT ProgramNashvilleTennessee37203-
VA Tennessee Valley Healthcare SystemNashvilleTennessee37212-
Vanderbilt UniversityNashvilleTennessee37232
Michael Byrne, MD
Michael Byrne, MD (PRINCIPAL_INVESTIGATOR)
Amarillo Blood and Marrow Transplant ProgramAmarilloTexas79106-
Children's Medical Center DallasDallasTexas75235
Victor Aquino, MD
Victor Aquino, MD (PRINCIPAL_INVESTIGATOR)
Medical City DallasDallasTexas75230
Vikas Bhushan, MD
Vikas Bhushan, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390-
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)Fort Sam HoustonTexas78234
Gilbert Ancira, MD
210-916-4808
Gilbert Ancira, MD (PRINCIPAL_INVESTIGATOR)
Cook Children's HospitalFort WorthTexas76104
Gretchen Eames, MD
Gretchen Eames, MD (PRINCIPAL_INVESTIGATOR)
M.D. Anderson Cancer CenterHoustonTexas77030
Elizabeth Shpall, MD
Elizabeth Shpall, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Hospital - Baylor Medical CenterHoustonTexas77030
George Carrum, MD
832-824-7695
George Carrum, MD (PRINCIPAL_INVESTIGATOR)
Southwest Cancer Treatment & Research CenterLubbockTexas79415-
Methodist Healthcare System of San Antonio/Texas Transplant InstituteSan AntonioTexas78229
Jose Cruz, MD
Jose Cruz, MD (PRINCIPAL_INVESTIGATOR)
The Children's Hospital of San AntonioSan AntonioTexas78207
Martin Andreansky, MD, PhD
Mark Schambura
Martin Andreansky, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Ahmad Rayes, MD
Ahmad Rayes, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22908
Karen Ballen, MD
Karen Ballen, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth UniversityRichmondVirginia23227
John McCarty, MD
804-828-4596
John McCarty, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research CenterSeattleWashington98109
Ann Dahlberg, MD
Ann Dahlberg, MD (PRINCIPAL_INVESTIGATOR)
VA Puget Sound HCSSeattleWashington98108-
West Virginia UniversityMorgantownWest Virginia26506-8110
Lauren Veltri, MD
Lauren Veltri, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin - MadisonMadisonWisconsin53792
Kenneth DeSantes, MD
Kenneth Desantes, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of WisconsinMilwaukeeWisconsin53226
David Margolis, MD
David Margolis, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226-

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