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:2/17/2019
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
sites
1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Randal Wada, MD
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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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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Boston, MA
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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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Boston, MA
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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
University of Chicago One of the world's premier academic and research institutions, the University of...
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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
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Margarida Silverman, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Ronald Paquette, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Renee Madden, MD
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Principal Investigator: Kamar Godder, MD
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
Principal Investigator: Amir Steinberg, MD
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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747 52nd St
Oakland, California 94609
(510) 428-3000
Principal Investigator: Mark Walters, MD
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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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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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Michael Boyer, MD
University of Utah Research is a major component in the life of the U benefiting...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Eric Anderson, MD
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Ann Dahlberg, MD
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Akron, Ohio 44308
Principal Investigator: Steven Kuerbitz@chmca.org, MD
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Gregory Yanik, M.D.
University of Michigan The University of Michigan was founded in 1817 as one of the...
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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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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
Principal Investigator: Scott Solomon, MD
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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598 Telfair Street
Augusta, Georgia 30912
Principal Investigator: Claude Sportes, MD
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Ralph Quinones, MD
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Jonathan Gutman, MD
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Baltimore, Maryland 21201
Principal Investigator: Aaron Rapoport, MD
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Baltimore, Maryland 21218
(410) 516-8000
Principal Investigator: Allen Chen, MD, PhD
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Beech Grove, Indiana 46107
Principal Investigator: Luke Akard, MD
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Bethesda, Maryland 20892
Principal Investigator: Elizabeth Kang, MD
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Bethesda, Maryland 20892
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Bethesda, Maryland 20892
Principal Investigator: Richard Childs, MD
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Boston, Massachusetts 02215
Principal Investigator: David Avigan, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Cory Cutler, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brandywine, Delaware 19803
Principal Investigator: Emi Caywood, MD
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Bronx, New York 10467
Principal Investigator: David Loeb, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Robert Stuart, MD
Phone: 843-792-4271
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Jeffrey Huo, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Tammy Kindwall-Keller, MD
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Reggie Duerst, 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
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Principal Investigator: Olga Frankfurt, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Sunita Nathan, MD
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Damiano Rondelli, MD
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Cincinnati, Ohio 45229
Principal Investigator: Stella Davies, MD
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Cincinnati, Ohio 45236
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Cleveland, Ohio 44194
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Columbus, Ohio 43210
Principal Investigator: Sumithira Vasu, MD
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Dallas, Texas 75230
Principal Investigator: Vikas Bhushan, 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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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Madhuri Vusirikala, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Denver, Colorado 80218
Principal Investigator: Peter McSweeney, MD
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Detroit, Michigan 48201
Principal Investigator: Voravit Ratanatharathorn, MD
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Sureyya Savasan, MD
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, Michigan 48202
Principal Investigator: Nalini Janakiraman, MD
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Duarte, California 91010
Principal Investigator: Chatchada Karanes, MD
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Joanne Kurtzberg, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fort Sam Houston, Texas 78234
Principal Investigator: Russell Baur, MD
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Fort Worth, Texas 76104
Principal Investigator: Gretchen Eames, MD
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Gainesville, Florida 32610
Principal Investigator: John R Wingard, MD
Phone: 352-273-8022
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Gilbert, Arizona 85234
Principal Investigator: Rajneesh Nath, MD
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Glendale, California 91204
Principal Investigator: Neena Kapoor, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Aly Abdel-Mageed, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Aly Abdel-Mageed, MD
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Alfred Gillio, MD
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Hershey, Pennsylvania 17033
Principal Investigator: Witold Rybka, MD
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Houston, Texas 77030
Principal Investigator: Elizabeth Shpall, MD
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Houston, Texas 77030
Principal Investigator: Robert Krance, MD
Phone: 832-824-4661
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Indianapolis, Indiana 46202
Principal Investigator: Sherif Farag, MD
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884 Lakeland Drive
Jackson, Mississippi 39216
Principal Investigator: Carolyn Bigelow, MD
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Jacksonville, Florida 32207
Principal Investigator: Michael Joyce, MD
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Jacksonville, Florida 32216
Principal Investigator: Vivek Roy, MD
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Kansas City, Missouri 64108
Principal Investigator: Rakesh Goyal, MD
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Edward Ball, MD
Phone: 858-822-6600
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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La Jolla, California 92037
Principal Investigator: Jeffrey W Andrey, MD
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Lake Success, New York 11042
Principal Investigator: Ruthee L Bayer, MD
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Gerhard Hildebrandt, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Loma Linda, California 92354
Principal Investigator: Rishikesh Chavan, MD
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Gary Schiller, MD
Phone: 310-206-5755
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Louisville, Kentucky 40202
Principal Investigator: William Tse, MD
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Lubbock, Texas 79415
Principal Investigator: Nicholas D'Cunha, MD
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Mark Juckett, MD
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Patrick Stiff, MD
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Memphis, Tennessee 38104
Principal Investigator: Yasser Khaled, MD
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Miami, Florida 33136
Principal Investigator: Krishna Komanduri, MD
Phone: 305-243-6355
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Miami, Florida
Principal Investigator: Martin Andreansky, MD
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: David Margolis, MD
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Parameswaran Hari, MD
Phone: 414-805-4600
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Michael Craig, MD
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Nashville, Tennessee 37212
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Michael Byrne, MD
Phone: 615-936-8422
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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
Principal Investigator: Michael Kent, MD
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New Hyde Park, New York 11040
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New Orleans, Louisiana 70112
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New Orleans, Louisiana 70118
Principal Investigator: Lolie Yu, MD
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New York, New York 10021
Principal Investigator: Koen van Besien, MD
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New York, New York 10032
Principal Investigator: Monica Bhatia, MD
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New York, New York 10595
Principal Investigator: Mitchell Cairo, MD
Phone: 914-594-3640
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