Navigation Links
FDA Approves New York Blood Center's HEMACORD™ for Stem Cell Transplantation
Date:11/10/2011

NEW YORK, Nov. 10, 2011 /PRNewswire-USNewswire/ -- The Food and Drug Administration has licensed HEMACORD™ (Hematopoietic Progenitor Cells-Cord, HPC-C) for allogeneic hematopoietic (blood-forming) stem cell transplantation, the first such approval of a stem cell product in the world.  

According to the Food and Drug Administration's notification to New York Blood Center (NYBC), HEMACORD™ is "indicated for use in unrelated donor hematopoietic progenitor cell transplantation procedures… in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment."  Such conditions could include patients with hematologic malignancies, primary immunodeficiency diseases, bone marrow failure, and beta-thalassemia.  HEMACORD™ is indicated for use with children.

"We are thrilled to be the first public cord blood bank with an FDA-licensed product for transplantation," said Christopher D. Hillyer, MD, President and CEO of New York Blood Center (NYBC).  Since 1996, NYBC's National Cord Blood Program (NCBP) at the Howard P. Milstein National Cord Blood Center has provided cord blood units for transplantation under an Investigational New Drug (IND) exemption from the FDA.  The mission of the NCBP is to facilitate access to cord blood as a treatment option for patients, notably those from diverse ethnic backgrounds.  

To obtain FDA licensure of HEMACORD™, all collection and manufacturing conditions of the cord blood units met FDA standards for product potency, purity and efficacy, and patient safety.  NCBP's Biologics License Application (BLA) included extensive documentation of the systems and controls used, and the validations performed to ensure compliance with FDA standards in all steps of manufacturing (collections, processing, testing, typing, cryopreservation, storage, distribution and shipping) cord blood units for clinical use. Further, it included the safety data from the transplantation of more than 4,000 cord blood grafts. In advance of the BLA submission, NCBP moved its entire manufacturing and storage resources to a state-of-the-art facility in Long Island City, New York.

"The application process has been a rigorous and educational one for all of us at the National Cord Blood Program," said Pablo Rubinstein, MD, NYBC Vice President and Program Director of NCBP.  "We have always understood that providing high quality cord blood units for clinical use requires thorough scientific and technical definitions of methods, detailed analysis of results, and hard work.  Achieving systematic compliance with FDA Good Manufacturing Practices and Good Tissue Practices offers further assurance of the consistency, potency, purity, safety and efficacy of NCBP cord blood units."

About National Cord Blood Program (NCBP):  Launched in 1992, New York Blood Center's (NYBC) National Cord Blood Program (www.ncbp.us) at the Howard P. Milstein National Cord Blood Center, was the first established umbilical cord blood bank to collect, process, test and store cord blood units and make them available for transplantation to patients in need of hematopoietic stem cell transplantation.  The NCBP has provided more than 4,200 cord blood units for transplantation worldwide since its inception.  NCBP is a public cord blood bank and accepts requests from Transplant Centers and Registries all over the world.  Cord blood units can be accessed and searched directly through NCBP's WebSearch (https://tc.placentalblood.org/).  Cord blood units can also be accessed through Bone Marrow Donors Worldwide (BMDW), the National Marrow Donor Program, or by calling 718-752-4710 or 866-767-6227.  

About New York Blood Center:  New York Blood Center (NYBC), one of the nation's largest non-profit, community-based blood centers, has been providing blood, transfusion products and services to hospitals since 1964. NYBC currently serves more than 20 million people in New York City, Long Island, the Hudson Valley, New Jersey, and parts of Connecticut and Pennsylvania.  NYBC is also home to the Lindsley F. Kimball Research Institute and the National Cord Blood Program at the Howard P. Milstein National Cord Blood Center, the world's largest public cord blood bank.  NYBC provides medical services and programs (Clinical, Transfusion, and Hemophilia Services) through our medical professionals along with consultative services in transfusion medicine. Please visit us on Facebook at www.Facebook.com/newyorkbloodcenter.  Follow us on Twitter: @NY_BloodCenter.

Contact:
Christine Dingfelder
cdingfelder@nybloodcenter.org
212.835.1817 Office / 917.763.1648 Cell

PHOTOS AND VIDEO B-ROLL OF CORD BLOOD COLLECTION AND PROCESSING AVAILABLE ON REQUEST


'/>"/>
SOURCE New York Blood Center
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Consumers have ... and regulators/payers have placed more emphasis on patient ... patient support programs in the pharmaceutical industry have ... medications. Consequently, pharmaceutical companies are focusing on becoming ... are providing products and services that improve health. ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... addition of the "Structural Electronics 2015-2025: Applications, ... In-Mold Electronics, Smart ... Integrated Photovoltaics Structural electronics involves ... as load-bearing, protective structures, replacing dumb structures such ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... strategic partnership with Connance, a healthcare industry leader providing predictive analytics to ... technology combine to provide health systems, hospitals and ambulatory surgical centers with ...
(Date:6/27/2016)... ... 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best ... individuals in the United States and Canada wear eyeglasses. Once considered to be a ... and make a fashion statement. Even celebrities use glasses as a way of creating ...
(Date:6/26/2016)... Creek, Michigan (PRWEB) , ... June 26, 2016 , ... ... joined as sponsor of the 2016 Cereal Festival and World’s Longest Breakfast Table in ... in honor of the city’s history as home to some of the world’s leading ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/26/2016)... Lake Orion, Clarkston, Michigan (PRWEB) , ... June ... ... direction with respect to fertility once they have been diagnosed with endometriosis. These ... tolerable intercourse but they also require a comprehensive approach that can help for ...
Breaking Medicine News(10 mins):