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

Lisa Erickson, MPH - 10-CBA@ndmp.org

McCarty, John, M.
NCT01351545
HM13913
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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
DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Rushang Patel, MD - (rushang.patel.md@adventhealth.com)
Advocate Lutheran General Hospital Park Ridge, Illinois
All Children's Hospital St. Petersburg, Florida Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu)
Amarillo Blood and Marrow Transplant Program Amarillo, Texas
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Sonali Chaudhury, MD - (schaudhury@luriechildrens.org)
Arkansas Children's Hospital Little Rock, Arkansas Jason Farrar, MD - (JEFarrar@uams.edu)
Avera Transplant Institute Sioux Falls, South Dakota Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org)
Banner MD Anderson Cancer Center Gilbert, Arizona September Mitchell, RN - (september.mitchell@bannerhealth.com) Rajneesh Nath, MD - (rajneesh.nath@bannerhealth.com)
Beth Israel Deaconess Boston, Connecticut
Cardinal Glennon Children's Medical Center St Louis, Missouri Deepika Bhatla, MD - (dbhatla@slu.edu)
Children's Healthcare of Atlanta Atlanta, Georgia Ann Haight, MD - (Ann.haight@choa.org)
Children's Hospital Colorado Aurora, Colorado Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU)
Children's Hospital and Research Center of Oakland Oakland, California Mark Walters, MD - (mwalters@mail.cho.org)
Children's Hospital at Montefiore The Bronx, New York Mahvish Rahim, MD - (mrahim@montefiore.org)
Children's Hospital of Los Angeles Los Angeles, California Neena Kapoor, MD - (nkapoor@chla.usc.edu)
Children's Hospital of Michigan Detroit, Michigan Sureyya Savasan, MD - (ssavasan@med.wayne.edu)
Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana Lolie Yu, MD - (lyu@lsuhsc.edu)
Children's Hospital of Orange County (CHOC) Orange, California Rishikesh Chavan, MD - (rishikesh.chavan@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Nancy Bunin, MD - (buninn@email.chop.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Paul Szabolcs, MD - (Paul.szabolcs@chp.edu)
Children's Hospital of Wisconsin Milwaukee, Wisconsin David Margolis, MD - (dmargoli@mcw.edu)
Children's Medical Center Dallas Dallas, Texas Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu)
Children's Mercy Hospital and Clinics Kansas City, Missouri
Children's National Medical Center Washington D.C., District of Columbia David Jacobsohn, MD - (dajacobs@childrensnational.org)
Childrens Hospital Medical Center of Akron Akron, Ohio Megan Sampson, MD - (msampson@akronchildrens.org)
Cincinnati Children's Hospital Cincinnati, Ohio Stella Davies, MD - (stella.davies@cchmc.org)
City of Hope Duarte, California Monzr Al Malki, MD - (malmalki@coh.org)
Cleveland Clinic Cleveland, Ohio Craig Sauter, MD - (sauterc@ccf.org)
Cohen Children's Medical Center of New York New Hyde Park, New York Jonathan Fish, MD - (jfish1@nshs.edu)
Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York Monica Bhatia, MD - (mb2476@columbia.edu)
Cook Children's Hospital Fort Worth, Texas Gretchen Eames, MD - (gretchen.eames@cookchildrens.org)
Dana Farber Cancer Institute Boston, Massachusetts Corey Cutler, MD - (cscutler@partners.org)
Duke University Medical Center Durham, North Carolina Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu)
Emory University Hospital Atlanta, Georgia
Florida Center for Pediatric Cellular Therapy Orlando, Florida Susan Kelly, MD - (susan.kelly.md@flhosp.org)
Fred Hutchinson Cancer Research Center Seattle, Washington Ann Dahlberg, MD - (adahlber@fredhutch.org)
Greenebaum Cancer Center - University of Maryland Baltimore, Maryland
H Lee Moffitt Cancer Center Tampa, Florida
Hackensack University Medical Center Hackensack, New Jersey Alfred Gillio, MD - (agillio@humed.com)
Helen DeVos Children's Hospital Grand Rapids, Michigan Troy Quigg, MD - (troy.quigg@spectrumhealth.org)
Henry Ford Health System Jackson, Michigan Nalini Janakiraman, MD - (njanaki1@hfhs.org)
Indiana Blood & Marrow Transplantation Beech Grove, Indiana Luke Akard, MD - (lakard@ibmtindy.com)
Indiana University/Riley Hospital for Children Indianapolis, Indiana Jodi Skiles, MD - (jskiles@iu.edu)
Johns Hopkins Baltimore, Maryland Allen Chen, MD, PhD - (allenchen@jhmi.edu)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii Randal Wada, MD - (randalw@hawaii.edu)
Karmanos Cancer Institute Detroit, Michigan
Levine Children's Hospital Charlotte, North Carolina Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org)
Loma Linda University Cancer Center Loma Linda, California Hisham Abdel-Azim, MD - (habdelazim@llu.edu)
Loyola University Medical Center Maywood, Illinois Patrick Stiff, MD - (pstiff@lumc.edu)
M.D. Anderson Cancer Center Houston, Texas Elizabeth Shpall, MD - (eshpall@mdanderson.org)
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Jacksonville Jacksonville, Florida Vivek Roy, MD - (roy.vivek@mayo.edu)
Mayo Clinic Arizona (adults) Phoenix, Arizona James Slack, MD - (slack.james@mayo.edu)
Mayo Clinic Rochester Rochester, Minnesota
Medical City Dallas Dallas, Texas Vikas Bhushan, MD - (vikas.bhushan@usoncology.com)
Medical College of Georgia Augusta, Georgia Claude Sportes, MD - (csportes@gru.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Hamadani Mehdi, MD - (mhamadani@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Michelle Hudspeth, MD - (hudspeth@musc.edu)
Memorial Sloan-Kettering Cancer Center New York, New York Ioannis Politikos, MBBS - (politiki@mskcc.org)
Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee Fnu Kaweeta, MD - (fnu.kaweeta@mlh.org) Joshua Boss, RN - (fnu.kaweeta@westclinic.com)
Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com)
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Medical Center Miami Beach, Florida Alla Keyzner, MD - (alla.keyzner@mssm.edu)
NIH/NCI Bethesda, Maryland
Nationwide Children's Hospital Columbus, Ohio Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org)
Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware Emi Caywood, MD - (ecaywood@nemours.org)
Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida Michael Joyce, MD - (mjoyce@nemours.org)
New York Presbyterian Hospital at Cornell New York, New York Tsiporah Shore, MD - (tbs2001@med.cornell.edu)
New York University Langone Medical Center New York, New York A. Samer Al-Homsi, MD - (Samer.Al-Homsi@nyumc.org) Kelli Cole - (Kelli.cole@nyumc.org)
Nih/Nhlbi Bethesda, Maryland Richard Childs, MD - (childsr@nih.gov)
Nih/Niaid Bethesda, Maryland Elizabeth Kang, MD - (ekang@niaid.nih.gov)
Niklaus Children's Hospital Miami, Florida Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org)
North Shore University Hospital Manhasset, New York Ruthee L Bayer, MD - (rbayer@nshs.edu)
Northside Hospital Atlanta, Georgia Scott Solomon, MD - (ssolomon@bmtga.com)
Northwestern Memorial Hospital Chicago, Illinois Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu)
Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon Eneida Nemecek, MD - (nemeceke@ohsu.edu)
Orlando Health Bone Marrow Transplant and Cellular Therapy Orlando, Florida Yasser Khaled, MD - (yasser.khaled@orlandohealth.com)
Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu)
Phoenix Children's Hospital Phoenix, Arizona
Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com)
Rady Children's Hospital San Diego San Diego, California Eric Anderson, MD - (eanderson@rchsd.org)
Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu)
Roger Williams Medical Center Providence, Rhode Island Todd Roberts, MD - (todd.roberts@chartercare.org)
Roswell Park Cancer Institute Buffalo, New York Philip McCarthy, MD - (philip.mccarthy@roswellpark.org)
Rush University Medical Center Chicago, Illinois
Sarah Cannon BMT Program Nashville, Tennessee
Scripps Green Hospital La Jolla, California Jeffrey W Andrey, MD - (andrey.jeffrey@scrippshealth.org)
Southwest Cancer Treatment & Research Center Lubbock, Texas
Spectrum Health Grand Rapids, Michigan Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org)
St. Jude Childrens Research Hospital Memphis, Tennessee Renee Madden, MD - (renee.madden@stjude.org)
St. Louis University Medical Center St. Louis, Missouri Sagun Goyal, MD - (sgoyal3@slu.edu)
Stanford University Medical Center Palo Alto, California Andrew Rezvani, MD - (arezvani@stanford.edu)
Stony Brook University Hospital Stony Brook, New York Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu)
Strong Memorial Hospital/University of Rochester Rochester, New York Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu)
Sutter Medical Center Sacramento, California Michael Carroll, MD - (carrolmp@sutterhealth.org)
Texas Children's Hospital - Baylor Medical Center Houston, Texas Robert Krance, MD - (rakrance@txch.org)
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio Sumithira Vasu, MD - (sumithira.vasu@osumc.edu)
The Children's Hospital of San Antonio San Antonio, Texas Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org)
The Jewish Hospital Cincinnati, Ohio
Tufts Medical Center Boston, Massachusetts Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org)
Tulane Medical Center New Orleans, Louisiana Hana Safa, MD - (hsafah@tulane.edu)
UCLA Santa Monica, California Gary Schiller, MD - (gschiller@mednet.ucla.edu)
UCSF (adults) San Francisco, California
UCSF (peds) San Francisco, California
Univeristy of Mississippi Medical Center Jackson, Mississippi Carolyn Bigelow, MD - (cbigelow@umc.edu)
University Hospitals Case Medical Center Cleveland, Ohio Hillard Lazarus, MD - (hillard.lazarus@case.edu)
University of Alabama at Birmingham Birmingham, Alabama Joseph Chewning, MD - (jchewning@peds.uab.edu)
University of Arizona Medical Center - Tucson Tucson, Arizona Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu)
University of California San Diego San Diego, California Edward Ball, MD - (tball@ucsd.edu)
University of Chicago Chicago, Illinois James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu)
University of Colorado Hospital Aurora, Colorado Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu)
University of Florida Shands Medical Center Gainesville, Florida Jordan Milner, MD - (jordan.milner@ufl.edu)
University of Illinois at Chicago Chicago, Illinois Damiano Rondelli, MD - (drond@uic.edu)
University of Iowa Iowa City, Iowa Margarida Silverman, MD - (margarida-silverman@uiowa.edu)
University of Kansas Westwood, Kansas Joseph McGuirk, DO - (jmcguirk@kumc.edu)
University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky William Tse, MD - (w0tse002@louisville.edu)
University of Massachusetts Worcester, Massachusetts Jan Cerny, MD - (Jan.Cerny@umassmemorial.org)
University of Miami (adult) Miami, Florida
University of Miami (peds) Miami, Florida
University of Michigan Ann Arbor, Michigan Jessica Yu - (jjxyu@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Phyllis Warkenton, MD - (pwarkent@unmc.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina
University of Oklahoma Health Science Center Oklahoma City, Oklahoma Adam Asch, MD - (adam-asch@ouhsc.edu)
University of Pennsylvania/Thomas Jefferson Pittsburg, Pennsylvania Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Alison Sehgal, MD - (sehgalar@upmc.edu)
University of Texas Southwestern Medical Center Dallas, Texas
University of Utah Salt Lake City, Utah Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu)
University of Virginia Charlottesville, Virginia Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu)
University of Wisconsin - Madison Madison, Wisconsin Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu)
VA Puget Sound HCS Seattle, Washington
VA Tennessee Valley Healthcare System Nashville, Tennessee
Vanderbilt University Nashville, Tennessee Michael Byrne, MD - (michael.byrne@vumc.org)
Virginia Commonwealth University Richmond, Virginia John McCarty, MD - (jmccarty@vcu.edu)
Wake Forest University Winston-Salem, North Carolina
Washington University St. Louis St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
Washington University/St. Louis Children's Hospital St Louis, Missouri Geoffrey Uy, MD - (guy@wustl.edu)
West Virginia University Morgantown, West Virginia Lauren Veltri, MD - (lveltri@hsc.wvu.edu)
Westchester Medical Center Valhalla, New York Mitchell Cairo, MD - (mitchell_cairo@nymc.edu)
Western Penn Hospital Pittsburg, Pennsylvania John Lister, MD - (Jlister@wpahs.org)
Yale New Haven Hospital New Haven, Connecticut Aaron Flagg, MD - (aron.flagg@yale.edu)
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil)

Liver Cirrhosis Network Cohort Study (LCN-C)

Crystal K Santillanes, MS - lcn@northwestern.edu

NCT05740358
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Inclusion Criteria:
* Age ≥ 18 years * Willing to provide samples at baseline * Cirrhosis Where Cirrhosis is defined as:
• At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis OR
• At least 2 of the following:
• Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past year 2. Liver stiffness: VCTE within one year prior to consent or during Screening ≥12.5 kPa or MRE within one year prior to consent or during Screening ≥5 kPa 3. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening 4. Either: FIB-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening 5. \>5 years METAVIR stage 4 fibrosis or Ishak stage 5-6
Exclusion Criteria:
* Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma * Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence * Known prior solid organ transplant or bone marrow transplant * Current participation in active medication treatment trials at the time of consent for LCN Cohort Study * Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits * Bariatric surgery in the last 180 days prior to consent * Known history of fontan procedure-associated liver disease (FALD) * Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with or prevent follow-up per protocol * Current liver-unrelated end-stage organ failures (Dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen, current known active malignancy besides non-melanomatous skin cancer or carcinoma in situ) * Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent * Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis) * In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent * Documented cardiac cirrhosis * Known recent (within the last 365 days) or present hepatic decompensation with ascites/hydrothorax (including trace ascites discovered at screening not requiring intervention), hepatic encephalopathy or variceal bleeding. If a patient has had a history of decompensation, they must have been off any medications to treat decompensation for at least 365 days. Refer to the MOP for clarifying details on evaluating eligibility for patients with a history of prior decompensation. * Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples) * Current model for end-stage liver disease (MELD-Na) cut off ≥ 15\* * Current Child-Turcotte-Pugh (CTP) B or C\* * Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR) * Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy\* * In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) \> 2X upper limit of normal (ULN) within 90 days prior to consent or during Screening\* * In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 90 days prior to consent or during Screening\* * Indicates an exclusion criterion that may depend on laboratory results and other clinical assessments to be ordered during Screening after confirming the participant is otherwise eligible. If the test was performed as standard-of-care in the 90 days prior to consent, it does not need to be re-done for eligibility.
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis, Biliary, Cirrhosis Cryptogenic, Cirrhosis Due to Hepatitis C, Cirrhosis Due to Primary Sclerosing Cholangitis, Autoimmune Hepatitis
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease, NASH, Nonalcoholic steatohepatitis
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Study Locations

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Location Contacts
Central Virginia Veterans Healthcare System Richmond, Virginia Jasmohan Bajaj - (jasmohan.bajaj@vcuhealth.org)
Cleveland Clinic Cleveland, Ohio Srinivasan Dasarathy - (DASARAS@ccf.org)
Columbia University Iriving School of Medicine New York, New York Elizabeth Verna - (ev77@cumc.columbia.edu)
Duke Liver Center Durham, North Carolina Cynthia Moylan - (cynthia.moylan@duke.edu)
Keck Medical Center of USC Los Angeles, California Norah Terrault - (norah.terrault@med.usc.edu)
LAC + USC Medical Center Los Angeles, California Norah Terrault - (norah.terrault@med.usc.edu)
Mayo Clinic Rochester, Minnesota Vijay Shah - (Shah.Vijay@mayo.edu)
New York Presbyterian/Weill Cornell New York, New York Robert Brown - (rsb2005@med.cornell.edu)
UCSF Medical Center San Francisco, California Bilal Hameed - (bilal.hameed@ucsf.edu)
UCSF/Zuckerberg San Francisco General Hospital and Trauma Center San Francisco, California Mandana Khalili - (Mandana.Khalili@ucsf.edu)
University of California San Diego NAFLD Research Center La Jolla, California Rohit Loomba - (roloomba@health.ucsd.edu)
University of Miami Health System Miami, Florida David Goldberg - (dsgoldberg@med.miami.edu)
University of Michigan Ann Arbor, Michigan Elliot Tapper - (etapper@med.umich.edu)
Virginia Commonwealth University Richmond, Virginia Arun Sanyal - (arun.sanyal@vcuhealth.org)