A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)



Status:Recruiting
Conditions:Blood Cancer, Infectious Disease, HIV / AIDS, Lymphoma, Lymphoma, Women's Studies, Anemia, Endocrine, Hematology, Metabolic
Therapuetic Areas:Endocrinology, Hematology, Immunology / Infectious Diseases, Oncology, Pharmacology / Toxicology, Reproductive
Healthy:No
Age Range:Any
Updated:3/27/2019
Start Date:October 2011
Contact:Alisha Mussetter
Email:amussett@NMDP.ORG
Phone:763-406-4863

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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S.
transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

Primary Objective:

The primary objective of this study is to examine the incidence of neutrophil recovery of
≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are
not Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

- Assess incidence of transmission of infection

- Assess incidence of serious infusion reaction

- Determine 1 year overall survival after cord blood transplantation

- Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and
grades III to IV

- Assess cumulative incidence of chronic GVHD

- Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Inclusion Criteria:

- Disorders affecting the hematopoietic system that are inherited, acquired, or result
from myeloablative treatment

- Signed informed consent (and signed assent, if applicable) obtained prior to study
enrollment

- Pediatric and adult patients of any age

Exclusion Criteria:

- Patients who are receiving only licensed CBUs

- Cord blood transplant recipients at international transplant centers

- Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)

- Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
We found this trial at
144
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Saint Louis, Missouri 63104
Principal Investigator: Deepika Bhatla, MD
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Joseph Chewning, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Yi-Bin Chen, MD
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Andreas Klein, MD
Phone: 617-636-8884
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Philip McCarthy, MD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Kimberly Kasow, DO
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: John Cunningham, MD
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Navneet Majhail, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Jeffery Auletta, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
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Phone: 305-663-6851
Miami Children's Hospital Welcome to Miami Children
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
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747 52nd St
Oakland, California 94609
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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3020 Childrens way
San Diego, California 92123
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
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Akron, Ohio 44308
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Edmund Waller, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
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598 Telfair Street
Augusta, Georgia 30912
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13123 E 16th Ave
Aurora, Colorado 80045
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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Baltimore, Maryland 21201
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Baltimore, Maryland 21218
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Beech Grove, Indiana 46107
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Bethesda, Maryland 20892
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Bethesda, Maryland 20892
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Bethesda, Maryland 20892
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Boston, Massachusetts 02215
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Brandywine, Delaware 19803
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Bronx, New York 10467
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Robert Stuart, MD
Phone: 843-792-4271
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Charlotte, North Carolina 28204
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Charlottesville, Virginia 22903
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225 E Chicago Ave
Chicago, Illinois 60611
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251 E Huron St
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1653 W. Congress Parkway
Chicago, Illinois 60612
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2035 W Taylor St
Chicago, Illinois
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Cincinnati, Ohio 45229
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Cincinnati, Ohio 45236
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Cleveland, Ohio 44194
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Columbus, Ohio 43210
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Dallas, Texas 75230
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1935 Medical District Dr
Dallas, Texas 75235
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1801 Inwood Rd
Dallas, Texas 75390
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Denver, Colorado 80218
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Detroit, Michigan 48201
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3901 Beaubien St
Detroit, Michigan 48201
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Detroit, Michigan 48202
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Fort Sam Houston, Texas 78234
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Fort Worth, Texas 76104
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Gainesville, Florida 32610
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Gilbert, Arizona 85234
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Glendale, California 91204
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Grand Rapids, Michigan 49503
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Grand Rapids, Michigan 49503
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30 Prospect Ave
Hackensack, New Jersey 07601
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Hershey, Pennsylvania 17033
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1319 Punahou St
Honolulu, Hawaii 96826
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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884 Lakeland Drive
Jackson, Mississippi 39216
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Jacksonville, Florida 32207
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Jacksonville, Florida 32216
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Kansas City, Missouri 64108
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9500 Gilman Dr
La Jolla, California 92093
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Principal Investigator: Edward Ball, MD
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La Jolla, California 92037
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Lake Success, New York 11042
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Lexington, Kentucky
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Principal Investigator: Gerhard Hildebrandt, MD
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Loma Linda, California 92354
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Gary Schiller, MD
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Madison, Wisconsin 53706
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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Memphis, Tennessee 38104
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Miami, Florida 33136
Principal Investigator: Krishna Komanduri, MD
Phone: 305-243-6355
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Miami, Florida
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: David Margolis, MD
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Morgantown, West Virginia 26506
(304) 293-0111
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Nashville, Tennessee 37212
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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New Brunswick, New Jersey 08901
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70112
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New York, New York 10021
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New York, New York 10032
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