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Apheresis News Volume 2.05

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and free, monthly e-newsletter dedicated to the latest information affecting apheresis.
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June 06, 2007  // Volume 2.05
TOP STORY

Blood from Precancerous Donors Safe, Suggests Study
Blood transfusions from donors with undiagnosed cancer do not seem to increase the risk of cancer in recipients.

Extracorporeal Photopheresis May Be Effective in Treating Crohn’s Disease
Results from an international multi-center Phase II clinical trial suggest that extracorporeal photopheresis may be effective in treating patients with clinically active (OR symptomatic) Crohn’s disease who cannot tolerate or are refractory to immunosuppressants and/or anti-TNF agents.

SCIENCE

Scientists Create 'Plastic' Blood
Scientists have developed an artificial plastic blood which could act as a substitute in emergencies.

Elusive 'Ambulance' Cells are Created
The cells that help build the body's supply of blood and arteries have been created from human embryonic stem cells in substantial numbers for the first time. In theory, hemangioblasts could create large numbers of "universal donor" blood cells for transfusions in emergencies.

Blood Test May Improve Success of Bone Marrow Transplants
A simple blood test could mean the difference between life and death for bone marrow transplant recipients.

Gel Derived from a Patient's Own Blood May Help Promote Wound Healing
A preliminary study suggests that topical application of a gel made from platelets in healthy individuals’ own blood may help wounds heal more quickly and completely

Nephros to Initiate U.S. Clinical Trials
The Company recently received unconditional approval for its Investigational Device Exemption application from the Food and Drug Administration to begin a human clinical trial of the Company's OLpur(TM) H2H(TM) Hemodiafiltration Module and OLpur(TM) MD220 Hemodiafilter.

Aethlon Medical Releases Dengue Treatment Data
Aethlon Medical, Inc. has announced that researchers at the National Institute of Virology (NIV) in India have documented that the Aethlon Hemopurifier(R) is highly efficient in capturing infectious dengue virus.

Northfield Laboratories Reports Results of Pivotal Phase III Trauma Study
Northfield Laboratories, Inc. has reported results of its pivotal Phase III trauma trial with PolyHeme(R), its human hemoglobin-based oxygen-carrying red blood cell substitute.

Positive Statistical Analysis from Synthetic Blood's Oxycyte Traumatic Brain Injury Trial Indicates Achievement of Primary Endpoint
In line with preliminary study results announced in December 2006, statistical results confirmed that the primary endpoint of increasing patients' oxygen tension levels compared with baseline was met.

INTERCEPT Plasma Gains Registration in French Official Journal
As a result of this publication, French blood centers are authorized to prepare and sell plasma treated with the INTERCEPT Blood System.

FDA Approves Gen-Probe Blood-screening System
Gen-Probe Incorporated has announced that the U.S. Food and Drug Administration (FDA) has approved the Company's PROCLEIX(R) TIGRIS(R) system, the first fully automated molecular diagnostics instrument, for use with the PROCLEIX ULTRIO(R) assay.

Double Win for Hospital's Blood Tracking Project
A wireless blood tracking system designed to improve the delivery and administration of transfusions has helped John Radcliffe Hospital in Oxford secure a double win in a recent innovations award.

Hospital to Test Blood Transfusion Guidelines
Mayday Hospital in Croydon has been chosen to pilot a new electronic blood tracking system based on specifications that could set a national standard for managing blood transfusions.

Red Cross Goes Diskless
After a successful pilot, the 40,000-strong Red Cross Society in Australia will protect client medical and banking information using diskless notebooks as its preferred frontline mobile computing platform.

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Extracorporeal Photochemotherapy (ECP) in Treatment of Patients with c-GVHD and CTCL
The researchers evaluated the immunomodulatory and clinical effect of 279 extracorporeal photochemotherapy (ECP) procedures which were performed in six patients with chronic extensive GVHD and in two patients with CTCL (cutaneous T-cell lymphoma)/Mycosis fungoides.

Comparison of the Fenwal Amicus and Fresenius Com.Tec Cell Separators for Autologous Peripheral Blood Progenitor Cell Collection
This study was undertaken to evaluate blood cell separators with respect to separation results and content of the harvest.

BUSINESS

Agreement Signed to Sell Gambro Healthcare
Gambro Holding AB, jointly owned by Investor (49%) and EQT (51%), has signed an agreement to sell Gambro Healthcare to the private equity firm Bridgepoint. Gambro Healthcare operates 155 dialysis clinics in 15 countries.

JEGC OCC Corp. Agrees to Purchase Ownership Stake in OccuLogix, Inc. from TLC Vision Corporation
The Purchased Shares represent approximately 36% of the outstanding shares of common stock of OccuLogix based on information provided by OccuLogix.

Azani Medical Spa Introduces NeoStem's Adult Stem Cell Collection and Banking Services to Eastern PA and Western NJ
Azani Medical Spa has announced an agreement with the New York City-based biotechnology services company NeoStem, Inc. to become the first facility in Eastern Pennsylvania and Western New Jersey to offer adult stem cell collection and long-term storage services to the public.

DomaniCell Supports National Children’s Health Fund
DomaniCell, LLC has announced its support of the Children’s Health Fund (CHF) by participating in the CHF 20th anniversary gala dinner.

Grifols Signs Deal to Run Four New US Blood Plasma Centres, Invests 13 Million USD
Grifols SA said it has signed an agreement with an unnamed company to manage four new blood plasma centres in the US on an initial investment of 13 million USD.

Zenotech Plans Plasma Facility
Hyderabad-Based Zenotech Laboratories is looking at setting up a plasma fractionation facility at an investment of $20-25 million.

United Biotech Enters In-licensing Agreement
Drug maker United Biotech has enterd into an in-licensing deal with Italy's Kerdion to manufacture and market the company's plasma derivatives in India.

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.

Bio-Rad Signs Definitive Agreement to Acquire DiaMed
Bio-Rad Laboratories has agreed to pay $390 million for DiaMed, which makes and sells reagents and technology for blood typing and screening.

Unilife, MedPro Safety Sign Deal for Blood Collection Device
Australia-based Unilife Medical Solutions Ltd. has signed a $20 million agreement with Kentucky-based MedPro Safety Products to develop new blood collection devices that have automatic safety features aimed at preventing unintentional needle sticks.

Immucor Settles Class Action Lawsuit
Immucor, Inc. has reported it has entered into an agreement to settle the previously reported class action lawsuits against the company and certain of its current and former directors and officers consolidated as In re Immucor, Inc. Securities Litigation in the United States District Court for the Northern District of Georgia.

Blood Transfusion Institute Gets New CEO
The Institute for Transfusion Medicine, one of the largest providers of blood product collection and distribution in the country, has named its new president and chief executive officer.

Immucor CFO Resigning at End of August
Blood-testing equipment maker Immucor Inc. has said that chief financial officer Patrick Waddy will resign Aug. 31.

FUNDING & PROGRAMS

Jobs to Careers
Jobs to Careers will support projects that involve emerging or existing partnerships of at least one health or health care employer and at least one educational institution (e.g., a community college) that provides academic credit or an industry-recognized credential.

NIH Announces Changes to eRA Commons, Particularly the Electronic Streamlined Non-competing Award Process (eSNAP) Function

A Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24) (RFA-CA-07-506)

REGULATORY

Bush Signs Red Cross Bill
President Bush signed a bill into law Friday that overhauls the way the American Red Cross governs itself and streamlines its leadership in an effort to avoid the type of problems that beset its response to Hurricane Katrina.

Death Spurs Donor Registry Plea
Rep. Peter Koutoujian (D-Newton) has filed a bill that would require hospitals to report cases of TRALI to a Department of Public Health registry.


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

Erythropoiesis Stimulating Agents (ESAs) for Non-renal Disease Indications

Clinical Trial Policy

CMS Proposes Payment Reforms for Inpatient Hospital Services in 2008

Uniform Billing (UB-04) Implementation – UB-92 Replacement

Update to Information Regarding Medicare Payment and Coding for Drugs and Bologicals

Medicare Part B Drug Coding and Payment Refinements

Physician Quality Reporting Initiative (PQRI) Coding & Reporting Principles

Proper Use of Modifier “-59”

Clarification of Skilled Nursing Facility (SNF) No Payment Billing

Emergency Update to the 2007 Medicare Physician Fee Schedule Database (MPFSDB)

MLN Matters


FOOD AND DRUG ADMINISTRATION (United States of America)

FDA Workshop on Licensure of Apheresis Blood Products

FDA Policy on Blood Donations from Men Who Have Sex with Other Men

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products

Potential Variant Creutzfeldt-Jakob Disease (vCJD) Risk From US Licensed Plasma-Derived Factor VIII (PdFVIII, Antihemophilic Factor) Products

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue- Based Products: Establishment Registration and Listing; Form Food and Drug Administration 3356; Eligibility Determination for Donors; and Current Good Tissue Practice

Substantially Equivalent 510(k) Device - ElDorado Donor Doc 1.0.0 - Wyndgate Technologies

Supplement Approval: Antihemophilic Factor/von Willebrand Factor Complex (Human) (Humate-P) - ZLB Behring L.L.C.

Cleared Biological 510(k) Device Applications - Update

Approved Biological Premarket Approval (PMA) Device Applications - Update

Providing Regulatory Submissions in Electronic Format — Receipt Date


DEPARTMENT OF HEALTH (Ireland)

Concern Over New Human Tissue and Cells Regulations
The Irish Fertility Society has written to the Department of Health and the Irish Medicines Board to highlight its concerns with the implementation of the new human tissue and cells regulations.


MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (Scottland)

Troubled Scottish Blood Bank Reopens
NHS Highland voluntary suspended blood bank services at Caithness last October after an inspection by the authority highlighted deficiencies in staff training records, quality assurance documents, the calibration and maintenance of equipment and environmental issues.


HEALTH MINISTRY (Russia)

Russian Officials Bar Export of Blood Samples, Courier Services Say
Customs officials have banned exports of blood samples and other biological materials from Russia, a decision that experts said could lead to the deaths of patients in need of bone marrow transplants and other treatment.


THERAPEUTIC GOODS ADMINISTRATION (Australia)

Medical Device Incident Reporting and Investigation Scheme (IRIS) Article Index 

Medical Device Incident Report Statistics 


FOOD AND DRUG ADMINISTRATION (China)

China Tackling Tainted Blood Products Industry
China's drug watchdog said quality supervisors would be dispatched to all of the country's blood manufacturers to ensure products were free of diseases like HIV and hepatitis.


WORLD HEALTH ORGANIZATION (International)

World Blood Donor Day 2007 Dedicated To Safe Blood For Safe Motherhood
World Blood Donor Day, celebrated every year on 14 June, will this year focus on the role of safe blood transfusions in preventing maternal deaths.

ASFA

Order the Fourth Special Issue of the Journal of Clinical Apheresis today!

The highlight of the Fourth Special Issue is the introduction of the comprehensive Fact Sheet format designed to summarize and condense the available medical literature pertaining to the treatment of a disease by apheresis into a succinct, practical, and evidence-based reference for apheresis medicine professionals. Each Fact Sheet outlines:

  • Assigned ASFA category
  • Disease incidence
  • Number of patients reported to have been treated
  • Types of reports appearing in the medical literature
  • Level of evidence for therapeutic apheresis use
  • General disease description and treatment
  • Rationale for apheresis
  • Recommended apheresis regimen
  • Parameters for discontinuation

The Fourth Special Issue is available for purchase through the ASFA website at www.apheresis.org.


Special Offer

ASFA is now offering you the opportunity to place a bulk order for the Fourth Special Issue at discounted rates! (Regular Price: $75/copy)

  • $70/copy when you purchase 20- 50 copies
  • $65/copy when you purchase 51-100 copies
  • $60/copy when you purchase over 100 copies

As an added bonus, for each copy of the Fourth Special Issue that you purchase, you will receive a complimentary print copy of the ASFA publication, Therapeutic Apheresis: A Guide to Billing and Securing Appropriate Reimbursement (2nd Edition). Together, these will serve as invaluable resources for your staff and clients, allowing them to update themselves on the medical literature pertaining to the use of therapeutic apheresis and to bill appropriately for apheresis procedures!

Please click on the link below to place a bulk order for the Fourth Special Issue of the Journal of Clinical Apheresis: Clinical Applications of Therapeutic Apheresis today!http://www.apheresis.org/~DOCUMENTS/ASFA_Journal_Bulk_Order_Form.pdf

For further information, contact:
Ashka Wirk, BSc, MBA
Executive Director
American Society for Apheresis
375 West 5th Avenue, Suite 201
Vancouver, BC, Canada V5Y 1J
T 604.484.2851
E asfa@apheresis.org
www.apheresis.org

JOB OPPORTUNITIES

Apheresis RN
VCU Health System

Clinical Nurses - Apheresis (Full Time & Per Diem)
Mount Sinai Medical Center

Clinical Nurse Manager - Donor Room/Apheresis Service (Full Time)
Mount Sinai Medical Center

FEATURED EVENT
FDA Workshop on Licensure of Apheresis Blood Products
Event Date: August 15, 2007
Event Location: Bethesda, Maryland
ANNOUNCEMENTS

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  3. Inclusion on the American Society for Apheresis website, receiving more than 400 unique visits daily, all from individuals with an interest in the field of apheresis.

This unique recruiting opportunity is available for only $500 per career posting.

Click here to begin recruiting today!

This newsletter is intended to be a useful and timely reference for those working or interested in apheresis. Because of the constantly changing nature of the Internet, some of the website links included herein may change without notice.
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