Study Tests Blood Stem Cells to Boost Immune System
A new method of increasing blood stem cells could one day promote quicker recovery of immune system function in patients who've undergone chemotherapy or bone marrow transplant for leukemia and other cancers.

Stem Cells Could Treat Diabetes
An early-stage study in mice shows potential of adult blood in yielding insulin-producing stem cells.

Benitec Commences HIV Study In Humans In Los Angeles
The Directors of Benitec are delighted to announce the commencement of Benitec's first HIV human clinical trial in collaboration with City of Hope, a biomedical research and treatment center located just outside Los Angeles.

Aethlon Medical Announces Approval of Clinical Study
Aethlon Medical, Inc. has announced that it has received approval to initiate clinical testing of the Hemopurifier(R) in human studies to be conducted at the Fortis Hospital in Delhi, India.

Fresenius Says New Study Confirms High-flux Dialyzers Increase Survival Chances
Fresenius Medical Care AG said a new study confirms that patients suffering from chronic kidney disease have higher survival chances if they are treated with high-flux dialyzers - like those produced by Fresenius Medical Care - rather than low-flux dialyzers.

Immucor's Echo Cleared by FDA for Marketing in U.S.
Immucor, Inc. has announced that the U.S. Food and Drug Administration has cleared Galileo Echo for marketing in the United States as of June 14, 2007.

Cerner Receives FDA Clearance for Cerner Bridge Transfusion Administration and Specimen Collections
Cerner Corp. has announced that Cerner Bridge(TM) Transfusion Administration and Specimen Collections software solution has received U.S. Food and Drug Administration (FDA) 510(k) pre-market notification clearance.

Blood Banks Must Recruit Immigrant Donors to Address Potential Supply Imbalance
A potentially dangerous imbalance in the blood supply could deplete available stock of O-positive blood. It is linked to a variance between the number of Type O donations and the increasing number of transfusions, primarily within Hispanic populations which are predominantly O-positive.

Blood Donors Angry Over Profits
A number of blood donors have called on the blood collection agency Sanquin to be more open about its commercial activities. In particular they want to know how much money the company makes from donated blood.

The Bloodgen Project: Improving The Blood Supply
The era in which standard serology tests divided populations into two basic blood groups, ABO and Rh, may soon be a thing of the past. Nearly a century after blood group analysis began, new technologies for genotyping of blood offer a far more accurate picture of blood groups.

Virginia Blood Services Replacing Forms
Would-be donors will answer questions using touch-screen computers.

Malaysia May Become World's Largest Producer Of Artificial Blood
Malaysia has big potentials as a blood substitute product producer if the country agrees to obtain the technology from the United States (US).

Pentagon Seeking Manufactured Blood
The U.S. military is looking for a way to create a blood supply without relying on human blood donors.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Frequent Plateletpheresis Does Not Clinically Significantly Decrease Platelet Counts in Donors
In October 2005, the US Food and Drug Administration issued draft guidance on collecting platelets (PLTs) by automated methods. This study found that the proposed restrictions are not required to prevent thrombocytopenia in frequent PLT donors and would adversely impact the supply of apheresis PLTs.

Automated Programs for Collection of Mononuclear Cells and Progenitor Cells by Two Separators for Peripheral Blood Progenitor Cell Transplantation: Comparison by a Randomized Crossover Study
The automated programs of Amicus (Baxter Healthcare) and Spectra (software Version 6.1, Gambro BCT) apheresis machines were compared in a crossover study.

Life Therapeutics to Deliver on Vertical Integration Strategy Through Partnership with Leading Fractionator
Life Therapeutics has provided details of an agreement with Kedrion S.p.A, a leading European speciality pharmaceutical company and Italy's largest fractionator, that will enable the company to deliver on its strategy to become a vertically integrated operator.

Cerus Announces Agreement to Supply the INTERCEPT Blood System for Platelets to French National Blood Service
Cerus Corporation has announced that it has signed an initial two-year agreement with the French national blood service, Etablissement Francais du Sang (EFS), for the INTERCEPT Blood System for platelets.

Aethlon Medical Signs Cooperative Research and Development Agreement with The U.S. Army Medical Research Institute of Infectious Diseases
The focus of the agreement is to explore the therapeutic efficacy of the Aethlon Hemopurifier(R) against viral hemorrhagic fever (VHF) targets, including, but not limited to Ebola Virus, Marburg Virus, Lassa Virus, and Machupo Virus.

BioLife Solutions Announces HypoThermosol(R) Supply and License Agreement with Bioheart Inc.
The 10-year agreement includes volume based pricing and an intellectual property escrow provision which grants Bioheart access under certain conditions to BioLife’s HypoThermosol storage and preservation media when used in the production and therapeutic delivery of Bioheart’s MyoCell(R), a cellbased therapy for heart failure.

Blood Bank Partnering with Hospitals
Eight local hospitals announced that they will use LifeSouth Community Blood Centers as their primary blood supplier and jointly invest up to $3 million to help the not-for-profit company set up local facilities.

BioTime To Seek New Marketing Partners For PentaLyte
BioTime, Inc. has announced that Hospira, Inc. has declined an opportunity to commercialize PentaLyte(R) under the terms offered by BioTime.

NxStage(R) Medical Announces Agreement to Acquire Medisystems Corporation and Certain Affiliated Entities
NxStage Medical, Inc. has announced that it had entered into a definitive agreement to acquire Medisystems Corporation and certain affiliated entities for 6.5 million shares of NxStage common stock.

Talecris Biotherapeutics Buys More Plasma Collection Centers
Talecris Plasma Resources has purchased three facilities from International BioResources. Another 10 could be opened as part of the deal with International BioResources.

Renal Advantage Inc. Increases Presence in California Through Addition of Two Dialysis Centers
The two separate transactions were completed on June 1, 2007, following final regulatory approval from the California Department of Health Services.

BD Biosciences and StemCell Technologies Launch Advanced Culture Environment for hESC Research
BD Biosciences and StemCell Technologies, Inc. announced today the launch of BD Matrigel(TM) hESC-qualified Matrix and mTeSR(TM)1 Maintenance Medium. 

EKF Introduces Data Management-system for Blood Donor Centres
Based on its worldwide established Hemo_Control devices for the detection of Hemoglobin, the "Manager" models are featured additionally by a Barcode reader, internal Bluetooth interface and special management functions. 

Welsh Firm Offers Cell Storage in US
The service, provided by a Newport-based company called Lifeforce, collects and stores white immune-system blood cells from healthy individuals.

Cold Storage is a Hot Prospect as American Startup Expands to Europe
Four years after its Indianapolis founding, BioStorage Technologies has opened its first European office, raised $8.3 million among investors and aims to reach $30 million in annual sales by 2012.

Fresenius' ProServe to be Disbanded, Helios and Vamed to Report to Parent Company
Fresenius said the restructure will increase efficiency and transparency within the company and meet demand at its burgeoning hospital business.

TLCVision Completes First Sale of OccuLogix Common Stock
TLC Vision Corporation has announced that it has completed the first sale of OccuLogix, Inc. common stock pursuant to its previously announced agreement with JEGC OCC Corp.

Aethlon Medical Announces Issuance of Virus Treatment Patent
The patent, "Method for Removal of Viruses from Blood by Lectin Affinity Hemodialysis," is integral to Aethlon's intellectual property portfolio as it defines methods that allow the Aethlon Hemopurifier(R) to selectively capture a broad-spectrum of viruses from blood.

Fenwal Signs 145,000 Square Foot Lease for New Headquarters
Fenwal Blood Technologies Inc. has signed a 15-year lease for 145,000 square feet in Kemper Lakes Business Center, a four-building, 1.1-million square foot office park.

HemaCare President and CEO Resigns
HemaCare Corp. President and CEO Judi Irving resigned. Chairman Julian Steffenhagen will step in as interim CEO until a replacement is named.

NIH Establishes Working Groups to Examine Peer Review
National Institutes of Health (NIH) Director Elias A. Zerhouni, M.D., announced today the formation of two working groups - one external, the other internal - to examine the NIH peer review process, with the goal of maximizing its effectiveness.

Change in Budgetary Guidelines for Initiative for Maximizing Student Development Awards (PAR-06-553)(NOT-GM-07-110)

Change in Budgetary Guidelines for Research Initiative for Scientific Enhancement Awards (PAR-06-548) (NOT-GM-07-111)

Extension of Expiration Date and Clarification of Eligibility for Reentry Supplement (NOT-OD-07-068)

NIH/AHRQ/NIOSH Announce Change in Electronic Submission Process – Federal Holidays Excluded from Application Viewing Window (NOT-OD-07-070)

Health IT Bill Headed for Senate Action
The Senate’s Health, Education, Labor and Pensions Committee has passed the Wired for Health Care Quality Act, which promises to modernize health care by upgrading technology, reducing administrative costs and diminishing medical errors caused by lack of information.

CENTERS FOR MEDICARE AND MEDICAID SERVICES (United States of America)

National Coverage Analyses- Extracorporeal Photopheresis

National Coverage Analyses - Autologous Blood Derived Products for Chronic Non-Healing Wounds

National Coverage Analyses - Autologous Stem Cell Transplantation (AuSCT) for Amyloidosis

National Coverage Analyses- Non-Autologous Blood Derived Products for Chronic Non-Healing Wounds (1st Recon)

National Coverage Analyses - Stem Cell Transplantation (1st Recon)

Inpatient Rehabilitation Facility PPS and the 75 Percent Rule

2007 Physician Quality Reporting Initiative (PQRI): New Educational Products are Now Available

FOOD AND DRUG ADMINISTRATION (United States of America)

Licensure of Apheresis Blood Products; Public Workshop - Submit Electronic Comments

Guidance for Industry - “Computer Crossmatch” (Electronic Based Testing for the Compatibility between the Donor’s Cell Type and the Recipient’s Serum or Plasma Type)

Guidance for Industry - Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs

Questions and Answers Concerning Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - Updated

Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Final Rule

Human Tissue Task Force 2007 Report

Cellular, Tissue and Gene Therapies Advisory Committee Meeting

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act

Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-market Approval of Medical Devices

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Substantially Equivalent 510(k) Device - Galileo Echo Automated Blood Bank System - Immucor, Inc

Substantially Equivalent 510(k) Device - WB corQC - Immucor, Inc

Substantially Equivalent 510(k) Device - DAT Positive Control Cell - Immucor, Inc

Substantially Equivalent 510(k) Device - Monoclonal Control - Immucor, Inc

HEALTH CANADA (Canada)

Online Consultation on the Proposed Regulations for Whole Blood and Blood Components

CANADIAN BLOOD SERVICES (Canada)

Court Refuses Verdict in Tainted Blood Case
Superior Court judge has refused to issue a verdict in a long-standing trial in which a drug firm and several physicians stand accused of negligence for giving patients a tainted blood product. Lawyers for three of the accused doctors have alleged the Crown didn't present enough evidence to prove its case.

Rulings Clear Way for $1 Billion to Hep C Victims
Canadians infected with hepatitis C from tainted blood transfusions welcomed court rulings that clear the way for a national $1 billion compensation package.

Canadian Blood Services Awaits Regulatory Approvals Before Testing for Chagas
The United States is already testing donated blood for a tropical disease caused by a parasite in Central and South America, but it will be a while before testing can begin in Canada.

NATIONAL HEALTH SERVICE (United Kingdom)

Blood Stocks Management Scheme: Inventory Practice Survey 2006 Report: “Stock Control & Training”

Consultations Met with Protests
Hundreds of trade union members working in the NHS Blood and Transplant service have taken part in protests as plans to consolidate England's ten blood processing and testing sites into three 'super centres' move forward.

IRISH BLOOD TRANSFUSION SERVICE (Ireland)

Blood Bank Scraps Work on Controversial IT System Upgrade
Work on the controversial eProgesa computer system in the Irish Blood Transfusion Ser­vice has been scrapped. The French computer system used by the IBTS and other blood transfusion services around the world is designed to ensure the safety of blood supply systems.

AUSTRALIA NEW ZEALAND THERAPEUTIC PRODUCTS AUTHORITY (Australia and New Zealand)

Draft Order: Medical Device Standards for Medical Devices Required to be Sterile

Draft Order: Conformity Assessment Standard for Quality Management Systems and Quality Assurance Techniques for the Manufacture of Medical Devices

HEALTH MINISTRY (China)

China Faces Threat From Illegal Blood Sales
China still faces a problem with the illegal sale of blood to hospitals, years after such trade sparked an AIDS outbreak in the central province of Henan.

FOOD AND DRUG ADMINISTRATION (China)

Chinese Hospitals Used Fake Drips
Chinese investigators say nearly 60 hospitals and pharmacies in north-eastern China have been using fake blood protein in patients' drips.

STATE BLOOD TRANSFUSION COUNCIL (INDIA)

Blood Banks to be Computerised
The State Blood Transfusion Council (SBTC) is all set to roll out a plan that identifies three Mumbai hospitals’ blood banks to be developed as ‘metropolitan banks’ plus seven regional referral banks with enough storage capacity for the city’s requirements. Also, it has plans to computerise blood banks for an online blood bank management system in every district.

THE NATIONAL BLOOD SERVICE ZIMBABWE (Zimbabwe)

Zimbabwe Becomes First in Africa Awarded ISO Certificate on Blood Provision
The National Blood Service Zimbabwe was awarded an ISO 9001-2000 certificate to become the first national blood service organization to receive such an accolade in Africa.

WORLD HEALTH ORGANIZATION (International)

New Initiative to Improve Mothers' Access to Safe Blood
WHO is launching a new initiative to improve the availability and use of safe blood to save the lives of women during and after childbirth.

ASFA Educational Webinar Series - Register Today!

The first ASFA educational webinar of the 2007 webinar series, Assessments and Considerations in Pediatric Therapeutic Apheresis: All Things Great and Small, will take place on July 11, 2007.

2007 Webinar Schedule

Assessments and Considerations in Pediatric Therapeutic Apheresis: All Things Great and Small
Christine Fernandez-Roig - RN, BSN, Kellogg Cancer Care Center, IL
July 11, 2007 (12pm – 1pm ET)

The New Approach to ASFA Indications for Therapeutic Apheresis
Marisa Marques, MD - University of Alabama At Birmingham Hospital, AL and Zbigniew M. Szczepiorkowski - MD, PhD, FCAP, Darmouth- Hitchcock Medical Center, NH
July 25, 2007 (12pm – 1pm ET)

Apheresis Certification
Patricia Golden, RN, HP(ASCP) - MN and Betty Kong, MT(ASCP), HP - ARUP Blood Services, UT
August 8, 2007 (12pm – 1pm ET)

Adverse Reactions during Apheresis
Lanne Maes, MD - University of Illinois At Chicago, IL
September 5, 2007 (12pm – 1pm ET)

Lipid Apheresis
Susan Leitman, MD - National Institute of Health Medical Center, MD
October 3, 2007 (12pm – 1pm ET)

Peripheral Blood Stem Cell Collections
Sergio Torloni, MD - Mayo Clinic, AZ
November 14, 2007 (12pm – 1pm ET)

Pediatric Apheresis
Jed Gorlin, MD, MBA - Memorial Blood Center, MN
December 5, 2007 (12pm – 1pm ET)

Registration:

ASFA Member: $75/session
Non-member: $90/session
Continuing Education Credits Per Additional Attendee: $25/session

Register today by visiting http://www.apheresis.org/asfa_webinars/index.cfm.

Apheresis RN
Loyola University Health System

Medical Science Liaison
Johnson & Johnson

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