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Apheresis News Volume 2.14

Apheresis News facilitates the exchange of information and resources between members of the global apheresis community by providing a website portal and free, bi-monthly e-newsletter dedicated to the latest information affecting apheresis.

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November 07, 2007  // Volume 2.14
TOP STORY
OccuLogix Suspends RHEO(TM) System Clinical Development Program
OccuLogix, Inc. today announced that following a comprehensive review of the respective costs and development time-lines associated with the products in its portfolio, and in light of the Company's current financial position, its Board of Directors and management have indefinitely suspended its RHEOTM System clinical development program in Dry Age-Related Macular Degeneration.
SCIENCE

New Peritoneal Dialysis Diagnostic Discovered
Thanks to a discovery by scientists at Robarts Research Institute and The University of Western Ontario, patients undergoing peritoneal dialysis may soon be able to worry less about the risks of infection and lessen their hospital stays.

Device To Capture And Treat Cells In Blood Stream?
MIT and University of Rochester researchers report important advances toward a therapeutic device that has the potential to capture cells as they flow through the blood stream and treat them.

Regenetech Achieves a 60-Fold Increase of Adult Stem Cells Through Its cellXpansion™ Process
Regenetech, Inc., the adult stem cell company which has built upon NASA licensed technology, announced that the Company has significantly augmented its cell multiplication capabilities for CD34+38- peripheral blood progenitor cells (adult stem cells).

Leukocyte Reduction Seen as Significant Advance in Transfusion Medicine, Experts Urge Universal Adoption
Experts called on government and medical organizations involved in blood transfusion to "reverse one of the most serious public health policy errors in the history of transfusion therapy in the United States."

Baxter Adds Recombinant Protein to Specialty Therapeutics Portfolio
The development of recombinant ADAMTS13, a bio-engineered version of a naturally occurring enzyme that plays a critical role in blood coagulation, will strengthen Baxter’s pre-clinical research and development pipeline for specialty therapeutics targeting rare diseases.

Renal Solutions, Inc. Announces FDA 510(k) Clearance of New Design of the Allient(R) Sorbent Hemodialysis System for Chronic and Acute Hemodialysis
Renal Solutions, Inc., the exclusive provider of advanced sorbent hemodialysis products and services for treatment of patients with renal failure, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its newly enhanced Allient(R) Sorbent Hemodialysis System in chronic and acute hemodialysis applications.

US Blood Donations Testing Positive For Chagas' Disease
In the ten months since FDA licensed the first blood-screening test for Chagas' disease, some 241 blood donations in the United States have tested positive,

Female Plasma May Not Be As Harmful As Once Thought
As the national blood banking community considers limiting the use plasma from female donors because of a rare but potentially catastrophic lung condition, researchers from Duke University Medical Center have shown that this policy change might be premature.

Aethlon Medical Initiates Human Clinical Studies
Aethlon Medical, Inc., a pioneer in developing medical devices to treat infectious disease, announced today that it has initiated clinical testing the Aethlon Hemopurifier(R) in human studies being conducted at the Fortis Hospital in Delhi, India.


ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Rapid and Effective CD3 T-cell Depletion With a Magnetic Cell Sorting Program to Produce Peripheral Blood Progenitor Cell Products for Haploidentical Transplantation in Children and Adults

How We Approach An Apheresis Request for a Category III, Category IV, or Noncategorized Indication

Peripheral Blood Progenitor Cell Mobilization With Intermediate-Dose Cyclophosphamide, Sequential Granulocyte-Macrophage–Colony-Stimulating Factor and Granulocyte–Colony-Stimulating Factor, and Scheduled Commencement of Leukapheresis in 225 Patients Undergoing Autologous Transplantation

Warm Storage of Whole Blood for 72 Hours

BUSINESS

FTC Requests Immucor Documents in Probe
Blood-testing equipment maker Immucor Inc. said the Federal Trade Commission has requested certain documents and information related to three acquisitions the company made from 1996 to 1999, and its pricing activities since then.

Progenitor Cell Therapy Adds Development and Manufacturing Expertise
Progenitor Cell Therapy, LLC announced the addition of Ms. Marta Schilling as its Director of Manufacturing Operations (West Coast). Marta Schilling is a cellular therapy specialist with over 20 years of experience spanning corporate research, development, clinical trials, customer training and support, and cGMP cell therapy manufacturing.

Haemonetics Expands Its Blood Management Leadership with Acquisition of Haemoscope Business Unit
Haemonetics Corporation, a global blood management solutions company, and Haemoscope Corporation, a privately held blood diagnostic company, announced a definitive agreement whereby Haemonetics will acquire Haemoscope's TEG® Thrombelastograph® Hemostasis Analyzer business for $44 million cash.

Arbios Announces SEPET(TM) Manufacturing Agreement With NxStage Medical
Arbios Systems, Inc. announced that it has entered into an exclusive manufacturing agreement with NxStage Medical, Inc., whereby NxStage will manufacture the SEPET(TM) Liver Assist Device developed by Arbios for use in treating liver failure. Arbios is currently seeking permission from the US Food and Drug Administration to begin a controlled pivotal clinical trial for SEPET(TM).

Pall Launches New Products to Increase Supply of Safe Blood
In addition to increasing safety and availability of blood, Pall’s new technologies enable more efficient use of blood components by putting an end to wasting valuable and limited donations without increasing hospital or blood center costs.

Boston Scientific to Cut 2,300 Jobs, Restructure
Boston Scientific Corp said on it would cut about 2,300 jobs, or about 9 percent of its workforce, and restructure or sell several business units as part of its efforts to reduce operating expenses.

NeoStem Spotlights Projected Multibillion-Dollar Adult Stem Cell Therapeutics Market in Latest Investor Video
Industry analysts predict that the adult stem cell industry will generate approximately $8.5 billion by 2016, should these therapies come to market as and when expected.

FUNDING & PROGRAMS
2008 NIH Director's Pioneer Award Program (DP1) (RFA-RM-08-013)
REGULATORY

FOOD AND DRUG ADMINISTRATION (United States of America)

Blood Establishment Computer System Validation in the User’s Facility

ISBT Label Checklist for Licensed Establishments

CENTRES FOR MEDICARE AND MEDICAID SERVICES (Unites States of America)

Decision Memo for Clinical Trial Policy (CAG-00071R2)

ASFA

Abstract Submission Site Now Open

The online site for submitting abstracts for presentation at the ASFA 2008 Annual Meeting is now open.

Physicians, scientists, and allied health professionals are encouraged to submit abstracts on all aspects of apheresis, including research, clinical, educational, or administrative topics/projects.

Abstracts will be considered for presentation in one of the following formats:
• Oral: A 10-minute oral presentation by an author plus 5 minutes for questions.
• Poster: A visual display. An author must be present. Posters will be displayed for the entire conference.

Abstracts are welcome from both ASFA members and non-members. There is no limit to the number of abstracts that an individual may submit.

Abstracts should be submitted only if an author intends to attend the meeting and present the abstract if accepted. Those presenting abstracts will be responsible for their own travel and meeting expenses. The rules applying to abstracts are indicated on the Abstract Submission System and must be followed. All abstracts will be published in the Journal of Clinical Apheresis.

BEST ABSTRACT AWARDS - Open to ASFA Members and Non-members

ASFA is pleased to offer Best Abstract Awards in the following categories. To be eligible for these awards, the applicant must be the first author and the author who will present the abstract. The following awards are open to both ASFA members and non-members:

• $1500 ASFA Donor Apheresis Best Abstract Award
• $1500 ASFA Gastroenterology Best Abstract Award
• $1500 ASFA Hematology Best Abstract Award supported by THERAKOS
• $1500 ASFA Nephrology Best Abstract Award
• $1500 ASFA Neurology Best Abstract Award
• $1500 ASFA Ophthalmology Best Abstract Award
• $1500 ASFA Rheumatology Best Abstract Award
• $1500 ASFA Transplantation Best Abstract Award

ALLIED HEALTH AND JUNIOR INVESTIGATOR AWARDS – Open to ASFA Members Only

ASFA also presents two prestigious awards reserved for ASFA members only. To be eligible for the following awards, one must be the first author, the author who will present the abstract, and an ASFA member:

• $1500 ASFA Allied Health Award
• $1500 ASFA Junior Investigator Award

The recipients of all of the above awards will be selected by the ASFA Abstracts Committee. ASFA may reject abstracts that are considered inappropriate for any reason. Abstracts, once submitted, cannot be withdrawn from publication.

Abstracts must be submitted via the online Abstract Submission System at www.apheresis.org/Abstracts/. Instructions for submission will be available on the Abstract Submission System, which will open on September 10, 2007. Abstracts will NOT be accepted by email, mail, or fax.

Abstract Submission Deadline: December 10, 2007 (11:59pm PT)

Click Here to Submit an Abstract

JOB OPPORTUNITIES
Apheresis Manager
Florida's Blood Centers
FEATURED EVENT
American Society of Hematology Annual Meeting and Exposition
Event Date: December 8-11, 2007
Event Location: Atlanta, Georgia
ANNOUNCEMENTS

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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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