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
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Houston, Texas 77030
Principal Investigator: Robert Krance, MD
Phone: 832-824-4661
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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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
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Phone: 617-636-8884
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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Chapel Hill, North Carolina 27599
(919) 962-2211
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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3500 Gaston Avenue
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
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8700 Beverly Blvd # 8211
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262 Danny Thomas Pl
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3100 SW 62nd Ave
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1 Gustave L Levy Pl # 271
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747 52nd St
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South 34th Street
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201 Presidents Circle
Salt Lake City, Utah 84108
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3020 Childrens way
San Diego, California 92123
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1100 Fairview Avenue North
Seattle, Washington 98109
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Akron, Ohio 44308
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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
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
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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
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Baltimore, Maryland 21201
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Beech Grove, Indiana 46107
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Boston, Massachusetts 02215
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450 Brookline Ave
Boston, Massachusetts 2215
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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
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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
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2035 W Taylor St
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1935 Medical District Dr
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1801 Inwood Rd
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Denver, Colorado 80218
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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
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Fort Sam Houston, Texas 78234
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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
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884 Lakeland Drive
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9500 Gilman Dr
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Los Angeles, California 90095
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2160 South 1st Avenue
Maywood, Illinois 60153
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Memphis, Tennessee 38104
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
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Morgantown, West Virginia 26506
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2201 West End Ave
Nashville, Tennessee 37232
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New Brunswick, New Jersey 08901
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20 York St, N20 York St,
New Haven, Connecticut 06520
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