Infusion Reactions Clinical Trial
Official title:
A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
| Verified date | March 2024 |
| Source | New York Blood Center |
| Contact | Dorothy Sung |
| Phone | 718-706-5202 |
| dsung[@]nybc.org | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
| Status | Recruiting |
| Enrollment | 9999 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: 1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. 2. Patients: Patients of any age and either gender 3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units) Exclusion Criteria: 1. Patients who are receiving licensed cord blood products (only) 2. Patients who are receiving unlicensed cord blood products from other banks (only) 3. Patients who are transplanted at non-US transplant centers 4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Akron Children's Hospital | Akron | Ohio |
| United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
| United States | Northside Hosptal | Atlanta | Georgia |
| United States | The Children's Hospital of Colorado | Aurora | Colorado |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | National Institutes of Health | Bethesda | Maryland |
| United States | Children's of Alabama | Birmingham | Alabama |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Dana Farber Cancer Instistute | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Seidman Cancer Center | Cleveland | Ohio |
| United States | Arthur G. James Cancer Hospital | Columbus | Ohio |
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | Children's Medical Center of Dallas | Dallas | Texas |
| United States | Presbyterian / St. Luke's Medical Center | Denver | Colorado |
| United States | Children's Hospital of Michigan | Detroit | Michigan |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | City of Hope | Duarte | California |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | Helen DeVos Children's Hospital | Grand Rapids | Michigan |
| United States | Penn State Health / Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Texas Children's Cancer Center | Houston | Texas |
| United States | Indiana University | Indianapolis | Indiana |
| United States | University of Mississippi Medical Center | Jackson | Mississippi |
| United States | Nemour's Children's Clinic and Hospital | Jacksonville | Florida |
| United States | UCSD Moores Cancer Center | La Jolla | California |
| United States | Northwell Health - North Shore University Hospital | Lake Success | New York |
| United States | Cedars Sinai Medical Center | Los Angeles | California |
| United States | UCLA Healthcare | Los Angeles | California |
| United States | James Graham Brown Cancer Center | Louisville | Kentucky |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | St Jude Children's Research Center | Memphis | Tennessee |
| United States | University of Miami Health System Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | University of Miami/Jackson Memorial Hospital | Miami | Florida |
| United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
| United States | West Virginia University Hospitals Inc | Morgantown | West Virginia |
| United States | Cohen Children's Medical Center of NY | New Hyde Park | New York |
| United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
| United States | Mount Sinai Hospital | New York | New York |
| United States | New York Presbyterian Hospital WCMC | New York | New York |
| United States | Stephenson Oklahoma Cancer Center | Oklahoma City | Oklahoma |
| United States | The Nebraska Medical Center | Omaha | Nebraska |
| United States | Florida Hospital, Florida Center for Cellular Therapy | Orlando | Florida |
| United States | Abramson Cancer Center of the University of Pennsylvania Medical Center | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | Phoenix Children's Hospital | Phoenix | Arizona |
| United States | Children's Hopsital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
| United States | Doernbecher Children's Hospital / Oregon Health & Science University | Portland | Oregon |
| United States | Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center | Saint Louis | Missouri |
| United States | St. Louis University Hospital | Saint Louis | Missouri |
| United States | All Children's Hospital, John Hopkins Medicine | Saint Petersburg | Florida |
| United States | Methodist Hospital / Texas Transplant Institute | San Antonio | Texas |
| United States | Rady Children's Hospital | San Diego | California |
| United States | Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Stanford Health Care | Stanford | California |
| United States | University of Arizona Medical Center | Tucson | Arizona |
| United States | Southwestern Regional Medical Center | Tulsa | Oklahoma |
| United States | Children's National Medical Center | Washington | District of Columbia |
| United States | Alfred I. DuPont Hospital for Children | Wilmington | Delaware |
| United States | Midwestern Regional Medical Center | Zion | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| New York Blood Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | engraftment | This outcome will evaluate engraftment of unlicensed cord blood units | six months after transplant |