Volume 8.26 | Jul 9

Volume 8.26, July 9, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Engineered Blood Vessels Function like Native Tissue: Blood vessels that have been tissue-engineered from bone marrow adult stem cells may in the future serve as a patient’s own source of new blood vessels following a coronary bypass or other procedures that require vessel replacement.
Article

Science

Fat Kills Cancer: Turning Stem Cells Taken from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
Researchers in Slovakia have been able to derive mesenchymal stem cells from human adipose, or fat, tissue and engineer them into “suicide genes” that seek out and destroy tumors like tiny homing missiles.
Article

Researchers Use Adult Stem Cells to Create Soft Tissue
A Columbia research team aims to create long-lasting soft tissue implants from mesenchymal stem cells harvested from the patient’s own bone marrow or adipose tissue.
Article

Cloned Sperm Created in the Lab
Cloning sperm could enable men with very low sperm counts to become fathers.
Article

Insight into Neural Stem Cells has Implications for Designing Therapies
Scientists have discovered that adult neural stem cells, which exist in the brain throughout life, are not a single, homogeneous group. Instead, they are a diverse group of cells, each capable of giving rise to specific types of neurons.
Article

Opexa Advances Monocyte Derived Islet Technology to Proof of Principle in stz-induced NOD/SCID Mice
Two recent presentations covered research from Opexa’s innovative adult stem cell program regarding the development of adult monocyte-derived islets, as beta-cell replacement therapy for diabetes mellitus.
Article

Stem Cell Transplants from Unrelated Donors Effective for Younger Patients with AML with Adverse Cytogenetics
Researchers affiliated with the International Blood and Marrow Transplant Registry have reported that stem cell transplants from unrelated donors are equally effective for patients with acute myeloid leukemia with favorable, intermediate and unfavorable cytogenetics who were 60 years of age or younger.
Article

Stem Cell Procedure Successfully Treats Amyloidosis Patients
Researchers from the Stem Cell Transplant Program and the Amyloid Treatment and Research Program at Boston University Medical Center (BUMC) have found that tandem cycles of high-dose chemotherapy and blood stem cell transplantation can help treat patients with immunoglobulin-light chain (AL) Amyloidosis who did not respond to initial treatment with this method.
Article

Injectable Filler Product Said to Abolish Anti-ageing Concerns
A suspension of human dermal fibroblasts in cell storage medium, the Vavelta facial rejuvenation product was introduced this week at the UK’s largest medical aesthetic conference.
Article

The Perfect Match: Bone Marrow Donation
New techniques make joining a registry and donating marrow easier and less painful.
Article

FDA Delay In Cancer Therapy Is Attacked
The debate over Provenge illustrates the highly charged atmosphere that often surrounds new treatments as the desperation of deathly ill patients increasingly converges with the high-stakes intensity of biotech investing in the anything-goes forum of the Internet.
Article

Seeking Hope in Chinese Stem Cells
The treatments may not work or even be safe, but dozens make the trek each month.
Article

ABSTRACTS, REVIEWS AND SPECIAL REPORTS

Concise Review: No Breakthroughs for Human Mesenchymal and Embryonic Stem Cell Culture: Conditioned Medium, Feeder Layer, or Feeder-Free; Medium with Fetal Calf Serum, Human Serum, or Enriched Plasma; Serum-Free, Serum Replacement Nonconditioned Medium, or Ad Hoc Formula? All That Glitters Is Not Gold!
Although clinical studies have already started, many questions remain unsolved, and concomitantly even more evidence on suitable and safe off-the-shelf products (mainly xeno-free) for embryonic and mesenchymal stem cells is cropping up, even though there should be no rush to enter the clinical stage while the underlying basic research is still not so solid.
Abstract

Cancer Vaccines: Moving Beyond Current Paradigms
Although no therapeutic cancer vaccine has to date been approved by the Food and Drug Administration, several new paradigms are emerging from recent clinical findings both in the use of combination therapy approaches and, perhaps more importantly, in clinical trial design and end point analyses
Abstract

Policy

Delaware Stem Cell Bill Defeated, Likely to Return
Legislation to regulate stem cell research in Delaware was defeated in a lopsided House vote, but an amended version of the bill is expected to resurface when lawmakers return in January.
Article

Stem Cells ‘to Boost’ Risky Egg Trade
Demand for eggs for stem cell research will put vulnerable women at increased pressure to sell their ova to unscrupulous dealers, says an Australian researcher.
Article

New Regulations Needed For Patients Receiving Animal Tissue Donation 
Although few xenotransplantation procedures have been done to this time, there appears to be a lack of awareness among potential xenotransplant patients about the risk of the procedures, and the required lifetime of infectious disease monitoring that come with it.
Article

Business

Tissue Genesis Signs Exclusive Distribution and License Agreement with Vet-Stem
Tissue Genesis received a combination of equity and royalties under the agreement, and expects in the future to receive revenue from the sales to Vet-Stem of TGI 1000(TM) cell isolation systems, TGI 1000 disposables and TGI 100(TM) kits.
Article

Oxford BioMedica and Sigma-aldrich Issue Joint Licence for Lentivector Technology to Major Biotechnology Company
Oxford BioMedica and Sigma-Aldrich have announced that they have signed a joint licence agreement for the LentiVector technology with a major US-based biotechnology company, which provides the company with access to the technology for global research activities.
Article

Community Blood Services and Coriell Institute Announce Cord Blood Collection and Research Alliance
Community Blood Services and Coriell Institute for Medical Research have announced a major strategic alliance creating the largest public cord blood bank in New Jersey. The public bank will be known as the New Jersey Cord Blood Bank.
Article

Thalassemia Patients Given a Better Chance
To offer people better health care, the Thailand Centre of Excellence for Life Science has teamed up with the Thai Red Cross to develop stem cell therapy and personalised medicine to treat thalassemia patients.
Article

Austin Company Says China has Pirated its Cancer Drug
Austin-based Introgen Therapeutics Inc. says a Chinese drug is basically stolen property, rushed to market with inadequate testing and in violation of patent rights.
Article

Scientists Enter Stem Cell Patents Fight
Some high-profile scientists have jumped into the fight over the University of Wisconsin-Madison’s stem cell patents, supporting the effort to have them revoked.
Article

BC Cancer Agency Granted $5 Million for Stem Cell Research
The work at the Centre’s Terry Fox Labratory will focus on understanding leukemic stem cells, because they share many of the characteristics of normal stem cells, making them hard to find and target.
Article

BD Biosciences Announces 2007 Research Grant Program
Four grant award recipients will share a total of $100,000 in high quality BD Biosciences research reagents.
Article

Baxter Representative Joins Progenitor Cell Therapy Board of Managers
Progenitor Cell Therapy, LLC has announced the addition of Mr. Paul Estrem to its Board of Managers. Mr. Estrem will replace Mr. Victor W. Schmitt as Baxter’s representative on the PCT Board.
Article

ViaCell Names John F. Thero Chief Financial Officer
ViaCell, Inc. has announced the appointment of John F. Thero as the Company’s Senior Vice President, Finance and Chief Financial Officer.
Article

Living Cell Technologies Enhances U.S. Capabilities: Appoints The Channel Group to Lead Commercial and Capital Markets Initiatives
Living Cell Technologies Limited has announced the appointment of Robert J. Beckman, Dr. Allan R. Goldberg and Philip N. Sussman, Managing Partners of The Channel Group, LLC, a New York based life science venture development and management firm, to the board of directors of Living Cell’s U.S. subsidiary LCT BioPharma Inc.
Article

NIH

Request for Information (RFI): NIH System to Support Biomedical and Behavioral Research and Peer Review (NOT-OD-07-074)
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CBER

Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
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Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
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Licensed Products and Establishments List – Update
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Questions and Answers Concerning Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) – Updated
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Questions and Answers Concerning the Current Good Tissue Practice (CGTP) Final Rule – Updated
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Questions and Answers Concerning the Donor Eligibility Final Rule and Guidance – Updated
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Regulatory

FOOD AND DRUG ADMINISTRATION (Untited States of America)

Request for Nominations for Voting Members on Public Advisory Panels or Committees
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Draft Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability
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THERAPEUTIC GOODS ADMINISTRATION

Important Notice – TGA Fees and Charges 2007-2008
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Therapeutic Goods Administration Business Plan 2007-2008
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AUSTRALIA NEW ZEALAND THERAPEUTIC PRODUCTS AUTHORITY (Australia and New Zealand)

ANZTPA Project E-newsletter Number 3, July 2007
Link

ISCT

7th Annual Somatic Cell Therapy Symposium
September 26-28, 2007
Hyatt Regency Bethesda, Maryland

Registration now open!  Click here to register.

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.
Link



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