Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
New York Blood Center
Study ID
NCT01656603
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Infusion Reactions

Eligibility Criteria

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

Interventions

  • unlicensed CBU — BIOLOGICAL
    infusion of unlicensed cord blood units

Study Details

This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.

Key Dates

Start date
Feb 29, 2012
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
9,999 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: unlicensed CBU
    The Principal Investigators will be the transplant physicians at participating US transplant centers

Primary Outcome Measure

Incidence of infusion-related reactions [ Time Frame: within 48 hours of infusion ]

Central Contacts

Locations (71)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233
Loretta Parker, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic ArizonaPhoenixArizona85054-
Phoenix Children's HospitalPhoenixArizona85016
Roberta H. Adams, MD (PRINCIPAL_INVESTIGATOR)
University of Arizona Medical CenterTucsonArizona85724-
City of HopeDuarteCalifornia91010
Monzr Al Malki, MD (PRINCIPAL_INVESTIGATOR)
UCSD Moores Cancer CenterLa JollaCalifornia92093
Edward Ball, MD (PRINCIPAL_INVESTIGATOR)
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
UCLA HealthcareLos AngelesCalifornia90095-
Rady Children's HospitalSan DiegoCalifornia92123
Eric J Anderson, MD (PRINCIPAL_INVESTIGATOR)
Stanford Health CareStanfordCalifornia94305
Andrew Rezvani, MD (PRINCIPAL_INVESTIGATOR)
The Children's Hospital of ColoradoAuroraColorado80045
Michael Verneris, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado HospitalAuroraColorado80045
Jonathan Gutman, MD (PRINCIPAL_INVESTIGATOR)
Presbyterian / St. Luke's Medical CenterDenverColorado80218
Alireza Eghtedar, MD (PRINCIPAL_INVESTIGATOR)
Alfred I. DuPont Hospital for ChildrenWilmingtonDelaware19901
Emi Caywood, MD (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
David A. Jacobsohn, MD (PRINCIPAL_INVESTIGATOR)
Nemour's Children's Clinic and HospitalJacksonvilleFlorida32207
Edward D Ziga, MD (PRINCIPAL_INVESTIGATOR)
University of Miami Health System Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
University of Miami/Jackson Memorial HospitalMiamiFlorida33136
Edward D. Ziga, MD (PRINCIPAL_INVESTIGATOR)
Florida Hospital, Florida Center for Cellular TherapyOrlandoFlorida32804
Rushang D. Patel, MD (PRINCIPAL_INVESTIGATOR)
All Children's Hospital, John Hopkins MedicineSt. PetersburgFlorida33701
Deepakbabu Chellapandian, MD (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of AtlantaAtlantaGeorgia30322
Ann Haight, MD (PRINCIPAL_INVESTIGATOR)
Northside HosptalAtlantaGeorgia30242
Scott R Solomon, MD (PRINCIPAL_INVESTIGATOR)
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Sonali Chaudhuri, MD (PRINCIPAL_INVESTIGATOR)
Northwestern Memorial HospitalChicagoIllinois60611
Kehinde Adekola, MD (PRINCIPAL_INVESTIGATOR)
Loyola University Medical CenterMaywoodIllinois60153-
Midwestern Regional Medical CenterZionIllinois60099-
Indiana UniversityIndianapolisIndiana46204
Jodi Lynn S. Skiles, MD (PRINCIPAL_INVESTIGATOR)
James Graham Brown Cancer CenterLouisvilleKentucky40102
Mohamed Hegazi, MD (PRINCIPAL_INVESTIGATOR)
National Institutes of HealthBethesdaMaryland20892
Richard Childs, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
David Avigan, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstistuteBostonMassachusetts02215
Corey Cutler, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Yi-Bin Chen, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of MichiganDetroitMichigan48201
Roland Chu, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Health SystemDetroitMichigan48202
Edward Peres, MD (PRINCIPAL_INVESTIGATOR)
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Troy Quigg, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905-
University of Mississippi Medical CenterJacksonMississippi39216
Carolyn L. Bigelow, MD (PRINCIPAL_INVESTIGATOR)
Barnes-Jewish Hospital at University of Washington / Sireman Cancer CenterSt LouisMissouri63110
Geoffrey Uy, MD (PRINCIPAL_INVESTIGATOR)
St. Louis University HospitalSt LouisMissouri63110
Sagun Goyal, MD (PRINCIPAL_INVESTIGATOR)
The Nebraska Medical CenterOmahaNebraska68198
Sachit Patel, MD
Sachit Patel, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health - North Shore University HospitalLake SuccessNew York10042
Ruthee-Lu Bayer, MD (PRINCIPAL_INVESTIGATOR)
Cohen Children's Medical Center of NYNew Hyde ParkNew York11042
Joel A Brochstein, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10067
Ioannis Politikos, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Alla Keyzner, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian Hospital WCMCNew YorkNew York10021
Tsiporah Shore, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical CenterRochesterNew York14642
Omar Aljitawi, MD (PRINCIPAL_INVESTIGATOR)
Akron Children's HospitalAkronOhio44308
Megan Sampson, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Stella Davies, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Craig Sauter, MD (PRINCIPAL_INVESTIGATOR)
Seidman Cancer CenterClevelandOhio44106
Brenda Cooper, MD (PRINCIPAL_INVESTIGATOR)
Arthur G. James Cancer HospitalColumbusOhio43210
Sumithara Vasu, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Hemalatha Rangarajan, MD (PRINCIPAL_INVESTIGATOR)
Stephenson Oklahoma Cancer CenterOklahoma CityOklahoma73104
George Selby, MD (PRINCIPAL_INVESTIGATOR)
Southwestern Regional Medical CenterTulsaOklahoma74133-
Doernbecher Children's Hospital / Oregon Health & Science UniversityPortlandOregon97239-
Penn State Health / Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Robert Greiner, MD
Robert Greiner, MD (PRINCIPAL_INVESTIGATOR)
Abramson Cancer Center of the University of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104
Elizabeth Hexner, 19104 (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Tim Olson, MD (PRINCIPAL_INVESTIGATOR)
Children's Hopsital of Pittsburgh of UPMCPittsburghPennsylvania15224
Paul Szabolcs, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Jennifer Jaroscak, MD (PRINCIPAL_INVESTIGATOR)
St Jude Children's Research CenterMemphisTennessee38105
Renee Madden, MD (PRINCIPAL_INVESTIGATOR)
Children's Medical Center of DallasDallasTexas75390-9063
Victor Aquino, MD (PRINCIPAL_INVESTIGATOR)
Cook Children's Medical CenterFort WorthTexas76104
Gretchen M Eames, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's Cancer CenterHoustonTexas77030
Robert Krance, MD (PRINCIPAL_INVESTIGATOR)
Methodist Hospital / Texas Transplant InstituteSan AntonioTexas78229-
University of VirginiaCharlottesvilleVirginia22905
Karen Ballen, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
John McCarty, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer Research Center / Seattle Cancer Care AllianceSeattleWashington98109
Ann Dahlberg, MD (PRINCIPAL_INVESTIGATOR)
West Virginia University Hospitals IncMorgantownWest Virginia26506
Kelly Ross, MD
Kelly Ross, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792
Christian Capitini, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of WisconsinMilwaukeeWisconsin53226
David A Margolis, MD (PRINCIPAL_INVESTIGATOR)

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