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This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
The primary aim of this study is to examine the safety of administration of the unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (HPC-CORD BLOOD) products in a multi-institution setting. Therefore, the study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP CBU.
Definitions of Infusion-related adverse reactions:
Mild - Moderate: reactions during or after the infusion of the cord blood (CB) product that require some medical intervention but do not affect the overall patient status or outcome.
Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unlicensed CBU | Experimental | The Principal Investigators will be the transplant physicians at participating US transplant centers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unlicensed CBU | Biological | infusion of unlicensed cord blood units |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infusion-related reactions | The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. The study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP cord blood units. | within 48 hours of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| engraftment | This outcome will evaluate engraftment of unlicensed cord blood units | six months after transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorothy Sung | Contact | 718-706-5202 | dsung@nybc.org | |
| National Cord Blood Program, New York Blood Center (General) | Contact | 917-710-9143 | ncbp@nybc.org |
| Name | Affiliation | Role |
|---|---|---|
| Eric Gehrie, MD | New York Blood Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Label | URL |
|---|---|
| New York Blood Center's National Cord Blood Program Website | View source |
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| Phoenix Children's Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
|
| Mayo Clinic Arizona | Completed | Phoenix | Arizona | 85054 | United States |
| University of Arizona Medical Center | Completed | Tucson | Arizona | 85724 | United States |
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
|
| UCSD Moores Cancer Center | Recruiting | La Jolla | California | 92093 | United States |
|
| Cedars Sinai Medical Center | Completed | Los Angeles | California | 90048 | United States |
| UCLA Healthcare | Completed | Los Angeles | California | 90095 | United States |
| Rady Children's Hospital | Recruiting | San Diego | California | 92123 | United States |
|
| Stanford Health Care | Recruiting | Stanford | California | 94305 | United States |
|
| The Children's Hospital of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
|
| University of Colorado Hospital | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Presbyterian / St. Luke's Medical Center | Recruiting | Denver | Colorado | 80218 | United States |
|
| Alfred I. DuPont Hospital for Children | Recruiting | Wilmington | Delaware | 19901 | United States |
|
| Children's National Medical Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Nemour's Children's Clinic and Hospital | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| University of Miami Health System Sylvester Comprehensive Cancer Center | Completed | Miami | Florida | 33136 | United States |
| University of Miami/Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136 | United States |
|
| Florida Hospital, Florida Center for Cellular Therapy | Recruiting | Orlando | Florida | 32804 | United States |
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| All Children's Hospital, John Hopkins Medicine | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| Northside Hosptal | Recruiting | Atlanta | Georgia | 30242 | United States |
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| Children's Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Loyola University Medical Center | Completed | Maywood | Illinois | 60153 | United States |
| Midwestern Regional Medical Center | Completed | Zion | Illinois | 60099 | United States |
| Indiana University | Recruiting | Indianapolis | Indiana | 46204 | United States |
|
| James Graham Brown Cancer Center | Recruiting | Louisville | Kentucky | 40102 | United States |
|
| National Institutes of Health | Recruiting | Bethesda | Maryland | 20892 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Dana Farber Cancer Instistute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| Children's Hospital of Michigan | Recruiting | Detroit | Michigan | 48201 | United States |
|
| Henry Ford Health System | Recruiting | Detroit | Michigan | 48202 | United States |
|
| Helen DeVos Children's Hospital | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| Mayo Clinic Rochester | Completed | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
|
| Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center | Recruiting | St Louis | Missouri | 63110 | United States |
|
| St. Louis University Hospital | Recruiting | St Louis | Missouri | 63110 | United States |
|
| The Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
|
| Northwell Health - North Shore University Hospital | Recruiting | Lake Success | New York | 10042 | United States |
|
| Cohen Children's Medical Center of NY | Recruiting | New Hyde Park | New York | 11042 | United States |
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| New York Presbyterian Hospital WCMC | Recruiting | New York | New York | 10021 | United States |
|
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
|
| Memorial Sloan-Kettering Cancer Center | Recruiting | New York | New York | 10067 | United States |
|
| University of Rochester Medical Center | Recruiting | Rochester | New York | 14642 | United States |
|
| Akron Children's Hospital | Recruiting | Akron | Ohio | 44308 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Seidman Cancer Center | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43205 | United States |
|
| Arthur G. James Cancer Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
|
| Stephenson Oklahoma Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Southwestern Regional Medical Center | Completed | Tulsa | Oklahoma | 74133 | United States |
| Doernbecher Children's Hospital / Oregon Health & Science University | Completed | Portland | Oregon | 97239 | United States |
| Penn State Health / Penn State Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Abramson Cancer Center of the University of Pennsylvania Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Children's Hopsital of Pittsburgh of UPMC | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| St Jude Children's Research Center | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Children's Medical Center of Dallas | Recruiting | Dallas | Texas | 75390-9063 | United States |
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| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Texas Children's Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Methodist Hospital / Texas Transplant Institute | Completed | San Antonio | Texas | 78229 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22905 | United States |
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| Virginia Commonwealth University Massey Cancer Center | Recruiting | Richmond | Virginia | 23298 | United States |
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| Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance | Recruiting | Seattle | Washington | 98109 | United States |
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| West Virginia University Hospitals Inc | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| University of Wisconsin Hospital and Clinics | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Children's Hospital of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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