Navigation Links
FDA Approves New York Blood Center's HEMACORDâ„¢ 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:12/8/2016)... KEY FINDINGS ... Patient warming and cooling devices offer several ... the risks of neurological disorders post cardiac arrests, rapid recovery ... systems can be segmented into convective warming system, surface warming ... stay at hospitals thus, lowering the healthcare costs by enhancing ...
(Date:12/8/2016)... 8, 2016 Global Interventional Radiology Market: ... global interventional radiology market analyzes the current and ... an elaborate executive summary, including a market snapshot ... sub-segments. The research is a combination of ... bulk of our research efforts along with information ...
(Date:12/8/2016)... 8, 2016 KEY FINDINGS ... of the market in 2016 and is expected to ... attributed to a large number of surgical procedures that ... largest share in the patient temperature management market.) Patient ... reducing loss of blood during surgeries, lowering the risks ...
Breaking Medicine Technology:
(Date:12/8/2016)... Ga (PRWEB) , ... December 08, 2016 , ... ... as soon after surgery as possible. With this in mind, SIGVARIS has created ... (DVT or blood clot) during bed rest and provide the benefits of graduated ...
(Date:12/8/2016)... ... December 08, 2016 , ... Dickinson Insurance and Financial Services, ... Little Rock, has initiated a charity drive to provide support and funding to ... Senior Hunger, Arkansas ranks first in senior hunger statewide, third in child hunger, ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... serve communities in and around the greater Phoenix metropolitan region, is announcing a ... , The mission of the Homeless Youth Connection is to promote community awareness ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... financial consulting services to residential and commercial clients in the northern Alabama and ... for Nobis Works. , Since 1977, Nobis Works has built a network of ...
(Date:12/7/2016)... ... December 07, 2016 , ... ... will have the unique opportunity to get hands-on experience in an emergency medical ... an immersive experience to gain invaluable, real-life medical skills that are critical success ...
Breaking Medicine News(10 mins):