Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation



Status:Recruiting
Healthy:No
Age Range:Any
Updated:11/3/2018
Start Date:February 2012
End Date:December 2020
Contact:Andromachi Scaradavou, MD
Email:ascaradavou@nybloodcenter.org
Phone:718-706-5207

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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

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 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 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).

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.)
We found this trial at
60
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Stella Davies, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Principal Investigator: Steven Kuerbitz, MD
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Karen Ballen, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: David Avigan, MD
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Hemalatha Rangarajan, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Sherif S. Farag, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Carolyn L. Bigelow, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Michael Lill, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1611 Northwest 12th Avenue
Miami, Florida 33136
Principal Investigator: Martin Andreasky, MD
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Nancy Bunin, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Principal Investigator: John McCarty, MD
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: E. Anders Kolb, MD
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Atlanta, Georgia 30242
Principal Investigator: Scott R Solomon, MD
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Principal Investigator: Ann Haight, MD
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Ralph Quinones, MD
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Jonathan Gutman, MD
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Bethesda, Maryland 20892
Principal Investigator: Richard Childs, MD
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Birmingham, Alabama 35233
Principal Investigator: Joseph Chewing, MD
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Boston, Massachusetts 02215
Principal Investigator: Corey Cutler, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jennifer Jaroscak, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Tamila Kindwall-Keller, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Sonali Chaudhuri, MD
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Olga Frankfurt, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland, Ohio 44106
Principal Investigator: Brenda Cooper, MD
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Navneet Majhail, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43210
Principal Investigator: Sumithara Vasu, MD
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Principal Investigator: Victor Aquino, MD
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Detroit, Michigan 48202
Principal Investigator: Edward Peres, MD
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Duarte, California 91010
Principal Investigator: Chatchada Karanes, MD
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Gretchen M Eames, MD
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Grand Rapids, Michigan 49503
Principal Investigator: Aly Abdel-Mageed, MD
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Houston, Texas 77030
Principal Investigator: Robert Krance, MD
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Jacksonville, Florida 32207
Principal Investigator: Michael Joyce, MD
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La Jolla, California 92093
Principal Investigator: Edward Ball, MD
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
Principal Investigator: William Tse, MD
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Mark Juckett, MD
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick J. Stiff, MD
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Memphis, Tennessee 38105
Principal Investigator: Mari Dallas, MD
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Miami, Florida 33136
Principal Investigator: Lazaros Lekakis, MD
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: David A Margolis, MD
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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New Hyde Park, New York 11040
Principal Investigator: Indira Sahdev, MD
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New York, New York 10021
Principal Investigator: Koen van Besien, MD
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Juliet Barker, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10029
Principal Investigator: Luis M. Isola, MD
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Oklahoma City, Oklahoma 73104
Principal Investigator: George Selby, MD
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Orlando, Florida 32804
Principal Investigator: Shahram Mori, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Elizabeth Hexner, 19104
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Roberta H. Adams, MD
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Pittsburgh, Pennsylvania 15224
Principal Investigator: Mark Vander Lugt, MD
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Rochester, Minnesota 55905
Principal Investigator: William J. Hogan, MD
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660 South Euclid Avenue
Saint Louis, Missouri 63110
Principal Investigator: Peter Westervelt, MD
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3635 Vista Avenue
Saint Louis, Missouri 63110
Principal Investigator: Sagun Goyal, MD
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501 6th Avenue South
Saint Petersburg, Florida 33701
Principal Investigator: Aleksandra Petrovic, MD
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San Antonio, Texas 78229
Principal Investigator: Robert Sanders, MD
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San Diego, California 92123
Principal Investigator: Eric J Anderson, MD
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Seattle, Washington 98109
Principal Investigator: Ann Woolfrey, MD
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Tucson, Arizona 85724
Principal Investigator: Emmanuel Katsanis, MD
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: David A. Jacobsohn, MD
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Zion, Illinois 60099
Principal Investigator: Istvan Redei, MD
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