Recruiting

Phase 2

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

Sponsor:

New York Blood Center

Code:

NCT01656603

Conditions

Infusion Reactions

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

unlicensed CBU

Study Details

Brief summary:

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

Conditions

Infusion Reactions

Study ID

NCT01656603

Start date

Feb, 2012

Status verified date

Apr, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

9999 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: unlicensed CBU

The Principal Investigators will be the transplant physicians at participating US transplant centers

Interventions

unlicensed CBU

infusion of unlicensed cord blood units

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dorothy Sung

718-706-5202 dsung@nybc.org

National Cord Blood Program, New York Blood Center (General)

917-710-9143 ncbp@nybc.org

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Principal Investigator:

Loretta Parker, MD

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Roberta H. Adams, MD

City of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Monzr Al Malki, MD

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Principal Investigator:

Edward Ball, MD

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Principal Investigator:

Eric J Anderson, MD

Stanford Health Care

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Andrew Rezvani, MD

The Children's Hospital of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Michael Verneris, MD

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Jonathan Gutman, MD

Presbyterian / St. Luke's Medical Center

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Alireza Eghtedar, MD

Alfred I. DuPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19901

Principal Investigator:

Emi Caywood, MD

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

David A. Jacobsohn, MD

Nemour's Children's Clinic and Hospital

Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator:

Edward D Ziga, MD

University of Miami/Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Edward D. Ziga, MD

Florida Hospital, Florida Center for Cellular Therapy

Recruiting

Orlando, Florida, United States, 32804

Principal Investigator:

Rushang D. Patel, MD

All Children's Hospital, John Hopkins Medicine

Recruiting

St. Petersburg, Florida, United States, 33701

Principal Investigator:

Deepakbabu Chellapandian, MD

Northside Hosptal

Recruiting

Atlanta, Georgia, United States, 30242

Principal Investigator:

Scott R Solomon, MD

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Ann Haight, MD

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Sonali Chaudhuri, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Kehinde Adekola, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46204

Principal Investigator:

Jodi Lynn S. Skiles, MD

James Graham Brown Cancer Center

Recruiting

Louisville, Kentucky, United States, 40102

Principal Investigator:

Mohamed Hegazi, MD

National Institutes of Health

Recruiting

Bethesda, Maryland, United States, 20892

Principal Investigator:

Richard Childs, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Yi-Bin Chen, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

David Avigan, MD

Dana Farber Cancer Instistute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Corey Cutler, MD

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Roland Chu, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator:

Edward Peres, MD

Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Troy Quigg, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator:

Carolyn L. Bigelow, MD

Barnes-Jewish Hospital at University of Washington / Sireman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Geoffrey Uy, MD

St. Louis University Hospital

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Sagun Goyal, MD

The Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Principal Investigator:

Sachit Patel, MD

Northwell Health - North Shore University Hospital

Recruiting

Lake Success, New York, United States, 10042

Principal Investigator:

Ruthee-Lu Bayer, MD

Cohen Children's Medical Center of NY

Recruiting

New Hyde Park, New York, United States, 11042

Principal Investigator:

Joel A Brochstein, MD

New York Presbyterian Hospital WCMC

Recruiting

New York, New York, United States, 10021

Principal Investigator:

Tsiporah Shore, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Alla Keyzner, MD

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10067

Principal Investigator:

Ioannis Politikos, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Principal Investigator:

Omar Aljitawi, MD

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Principal Investigator:

Megan Sampson, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Principal Investigator:

Stella Davies, MD

Seidman Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Brenda Cooper, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Craig Sauter, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Principal Investigator:

Hemalatha Rangarajan, MD

Arthur G. James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Sumithara Vasu, MD

Stephenson Oklahoma Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

George Selby, MD

Penn State Health / Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator:

Robert Greiner, MD

Abramson Cancer Center of the University of Pennsylvania Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Elizabeth Hexner, 19104

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Tim Olson, MD

Children's Hopsital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator:

Paul Szabolcs, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Jennifer Jaroscak, MD

St Jude Children's Research Center

Recruiting

Memphis, Tennessee, United States, 38105

Principal Investigator:

Renee Madden, MD

Children's Medical Center of Dallas

Recruiting

Dallas, Texas, United States, 75390-9063

Principal Investigator:

Victor Aquino, MD

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator:

Gretchen M Eames, MD

Texas Children's Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Robert Krance, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22905

Principal Investigator:

Karen Ballen, MD

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator:

John McCarty, MD

Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance

Recruiting

Seattle, Washington, United States, 98109

Principal Investigator:

Ann Dahlberg, MD

West Virginia University Hospitals Inc

Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator:

Kelly Ross, MD

University of Wisconsin Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

Christian Capitini, MD

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

David A Margolis, MD

More Information

Sponsor

New York Blood Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

cord blood
transplantation
stem cells
adverse event

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by New York Blood Center on 2026-04-13.