Volume 8.17 | May 7

Volume 8.17, May 7, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Gene Therapy For Childhood Blindness In First Clinical Trial: The first clinical trial to test a revolutionary treatment for blindness in children has been announced by researchers at University College London.


Stem Cell Propagation And Neurogenesis Can Now Be Studied In Cell Culture
Researchers are now able to study stem cells from the brains of adult mice and their neurogenesis in long-term cell cultures. Researchers have developed a new method which allows them to generate exactly those neurons from stem cells in cell culture as those that would develop in the living brain.

When Smell Cells Fail They Call in Stem Cell Reserves
Hopkins researchers have identified a backup supply of stem cells that can repair the most severe damage to the nerves responsible for our sense of smell. These reservists normally lie around and do nothing, but when neighboring cells die, the scientists say, the stem cells jump into action.

Adult Stem/progenitor Cells Repair Of Damaged Brain, Pancreas, Kidney Cells Newly Understood
New studies are shedding light on the previously mysterious mechanism through which even relatively small amounts of stem/progenitor cells taken from a patient’s own bone marrow enhance repair of damaged tissues.

Nanotechnology May Be Used to Regenerate Tissues, Organs
Research at Northwestern University has shown that a combination of nanotechnology and biology may enable damaged tissues and organs to heal themselves.

Schepens Scientists Identify Key To Integrating Transplanted Nerve Cells Into Injured Tissue
Scientists at the Schepens Eye Research Institute have identified a key mechanism for successfully transplanting tissue into the adult central nervous system.

Faster-Healing Artificial Skin
In work that has implications for those with severe burns, researchers have demonstrated in mice a new way to encourage skin regeneration.

Ceregene Presents Interim Phase 1 Clinical Data Of CERE-110 For The Treatment Of Alzheimer’s Disease
After one year of follow-up, the results for the six patients who received CERE-110 in the trial indicate that a single administration of the therapy was well tolerated, and an interim analysis suggested that the therapy had the potential to reduce the rate of cognitive decline and increase brain metabolism.

Aastrom Initiates Adult Stem Cell Clinical Trial for Peripheral Arterial Disease
Aastrom Biosciences, Inc. has announced that it has initiated its U.S. Phase IIb prospective, controlled, randomized, double-blind, multi-center clinical trial to treat patients suffering from peripheral arterial disease.

FDA Clearance Received for Heart Attack Stem Cell Clinical Trial
Mesoblast Limited has announced that the United States Food and Drug Administration has cleared the Investigational New Drug Submission of its US-based sister company, Angioblast Systems Inc., to commence a Phase 2 clinical trial of its allogeneic, or ‘off-the- shelf’, adult stem cells for patients with heart attacks.

Stem Cell Therapy Used in Cosmetic Surgery
A Vienna based cosmetic surgeon is the first to use stem cell technology in Europe.

Breakthrough to Aid Bone Marrow Patients
A joint project between Brisbane’s Mater Medical Research Institute and Sydney’s Westmead Hospital Bone Marrow Transplant Unit has developed a simple blood test that can tell which patients will develop life-threatening complications.

South Korean Team Cleared in Cloned Wolf Probe
South Korean scientists, whose reputation has been tainted by fraudulent stem cell studies, committed errors in a paper on producing the world’s first cloned grey wolves but did not manipulate data.


Enriched Monolayer Precursor Cell Cultures from Micro-Dissected Adult Mouse Dentate Gyrus Yield Functional Granule Cell-Like Neurons
In this study, researchers report the conditions required to generate adult murine dentate gyrus precursor cell cultures and to analyze functional properties of precursor cells and their differentiated granule cell-like progeny in vitro.

Contribution of Olfactory Neural Stem Cells to Tissue Maintenance and Regeneration
The researchers’ data supports a new model of adult neurogenesis in which distinct cell populations mediate normal neuronal turnover and neuronal replacement upon traumatic injury.


California Stem Cell Agency Temporarily Replaces Departed Leader
The California Institute for Regenerative Medicine named Lori Hoffman acting president and Arlene Chiu its interim chief scientific officer.

State Stem Cell Institute to Gather Public Input
The public will help California’s stem cell institute determine who should get a piece of the $220 million grant money set aside for the construction of new stem cell research labs.

Missouri Stem Cell Measure Defeated
A resolution that would have allowed voters to essentially overturn a recently passed amendment protecting embryonic stem cell research was voted down in the House Rules Committee.

Oregon Bill Would Support Stem Cell Research
Oregon would join a half-dozen states in helping fund stem cell research under a bill set for debate next week in the state House of Representatives.

Historic Cloning Law Passed in Victoria
Historic legislation to allow therapeutic cloning for stem cell production passed the Upper House of the state’s parliament in a historic conscience vote, 23 votes to 16.


Advanced Cell Technology and Wisconsin Alumni Research Foundation Announce Commercial License Agreement
The expanded agreement grants Advanced Cell rights to the commercial use of human embryonic stem cells to develop human therapies, with the exception of neuronal, pancreatic beta cells, and cardiac applications, and enables the marketing of a broad array of research products.

Ruling Could Aid Challenge to University of Wisconsin Stem Cell Patents
A Supreme Court ruling this week could make it more difficult for a Wisconsin foundation to defend key embryonic stem cell patents against challenges by two groups.

Blood Insurance
BioBanc USA is storing its healthy clients’ white blood cells for future use, when they are older and their immune systems are struggling.

StemCyte, Inc. Releases Its 500th Cord Blood Stem Cell Shipment For Transplant
StemCyte, Inc. recently released its 500th cord blood stem cell shipment for transplant.

Cord Blood Registry(R) Releases an Increasing Number of Stem Cell Samples to Treat a Broad Range of Medical Conditions
Cord Blood Registry(R) has announced that it has released a total of five stem cell samples in the first quarter of the year for transplant or infusion.

Millipore Announces New Chief Financial Officer
Millipore Corporation has announced that Charles Wagner has been appointed to succeed Kathleen Allen as the Company’s Chief Financial Officer.


NIH Announces Changes to eRA Commons, Particularly the Electronic Streamlined Non-competing Award Process (eSNAP) Function (NOT-OD-07-064)

Clarification on Page Limits and Budget Submissions for Bioengineering Research Partnerships (PAR-07-352) (NOT-EB-07-007)


Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P): Alphabetical List of Registered Establishments – Updated

SOPP 8401: Administrative Processing of Biologics License Application (BLA) – Updated

All new CBER information can be reached from the What’s New page at What’s New Page


FOOD AND DRUG ADMINISTRATION (Untited States of America)

Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop; Request for Comments


Panel Submits Stem Cell Guidelines to Health Ministry of India
A government panel has been set up to frame the stem cell guidelines in a bid to regulate the research activity in this emerging sector in India, has submitted the final guidelines to the Health Ministry.


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Profiled Journal

Current Issue: Volume 16, No. 1


Factors Influencing the Loss of ?-Cell Mass in Islet Transplantation
Juliet A. Emamaullee and A. M. James Shapiro

Original Contributions

Detection of Microbial Contamination During Human Islet Isolation
Tatsuya Kin, Shawn Rosichuk, A. M. James Shapiro, and Jonathan R. T. Lakey

Transient Beneficial Effects of Exendin-4 Treatment on the Function of Microencapsulated Mouse Pancreatic Islets
Sara Bohman, Ida Waern, Arne Andersson, and Aileen King

Resolution of Severe Atopic Dermatitis After Tacrolimus Withdrawal
Gaston M. Ponte, David A. Baidal, Paolo Romanelli, Raquel N. Faradji, Raffaella Poggioli, Pablo Cure, Tatiana Froud, Gennaro Selvaggi, Antonello Pileggi, Camillo Ricordi, and Rodolfo Alejandro

Transplantation of Cultured Adult Porcine Full-Thickness Retina
Karl Engelsberg and Fredrik Ghosh

Induction of Neurotrophin Expression Via Human Adult Mesenchymal Stem Cells: Implication for Cell Therapy in Neurodegenerative Diseases
Federica Pisati, Patrizia Bossolasco, Mirella Meregalli, Lidia Cova, Marzia Belicchi, Manuela Gavina, Chiara Marchesi, Cinzia Calzarossa, Davide Soligo, Giorgio Lambertenghi-Deliliers, Nereo Bresolin, Vincenzo Silani, Yvan Torrente, and Elio Polli

Plasma as a Scaffold for Regeneration of Neural Precursor Cells After Transplantation Into Rats With Spinal Cord Injury
Mitsuko Takenaga, Yuki Ohta, Yukie Tokura, Akemi Hamaguchi, Noboru Suzuki, Masaya Nakamura, Hideyuki Okano, and Rie Igarashi

Long-Term Maintenance of the Drug Transport Activity in Cyropreservation of Microencapsulated Rat Hepatocytes
Tomotake Koizumi, Takeshi Aoki, Yasuna Kobayashi, Daisuke Yasuda, Yoshihiko Izumida, Zhenghao Jin, Nobukazu Nishino, Yoshinori Shimizu, Hirohisa Kato, Noriyuki Murai, Takashi Niiya, Yuta Enami, Keitaro Mitamura, Toshinori Yamamoto, and Mitsuo Kusano

Tea Polyphenol Inhibits Allostimulation in Mixed Lymphocyte Culture
Jong-yoon Kim, Tatsuo Kina, Yasuhiro Iwanaga, Hirofumi Noguchi, Kazuaki Matsumura, and Suong-hyu Hyon

Functional and Phenotypic Alteration of Intrasplenic Lymphocytes Affected by Mesenchymal Stem Cells in a Murine Allosplenocyte Transfusion Model
Hong Li, Zi-Kuan Guo, Xiu-Sen Li, Chun-Mei Hou, Pei-Hsien Tang, and Ning Mao


Cell Transplantation publishes original, peer-reviewed research and review articles on the subject of cell transplantation and its application to human diseases. To ensure high-quality contributions from all areas of transplantation, separate section editors and editorial boards have been established. Articles deal with a wide range of topics including physiological, medical, preclinical, tissue engineering, and device-oriented aspects of transplantation of nervous system, endocrine, growth factor-secreting, bone marrow, epithelial, endothelial, and genetically engineered cells, among others. Basic clinical studies and immunological research papers are also featured. To provide complete coverage of this revolutionary field, Cell Transplantation will report on relevant technological advances, and ethical and regulatory considerations of cell transplants.

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