Volume 9.02 | Jan 21

Cell Therapy News 9.02, January 21, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Major Advancement Towards Creating Patient-Specific and Disease-Specific Stem Cells For Therapeutic Use: Stemagen has announced it has become the first in the world to create, and meticulously document, a cloned human embryo using somatic cell nuclear transfer (SCNT).


Personalized Medicine through Genomic Analysis and Molecular Diagnostics
March 31, 2008, Boston, Massachusetts
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Identification Of A Novel Neural Stem Cell Type
Researchers from the Sloan-Kettering Institute, led by Dr. Lorenz Studer, have discovered a novel type of neural stem cell, which has a broader differentiation potential than previously identified neural stem cells.

Stem Cells Modified to Home in Where They’re Needed
U.S. researchers have found a way to modify the surface of stem cells to direct them to where they’re needed, an advance that may prove useful in many areas of stem cell therapy.

Stem Cell Research Aims to Tackle Parkinson’s Disease
Scientists in Sweden are developing new ways to grow brain cells in the laboratory that could one day be used to treat patients with Parkinson’s disease.

Study Gives Insight Into Hair Growth
Researchers at USC have identified a new mechanism that controls the activation of stem cells during hair regeneration.

Researchers Create New Rat Heart in Lab
The researchers removed all the cells from a dead rat heart, leaving the valves and outer structure as scaffolding for new heart cells injected from newborn rats. Within two weeks, the new cells formed a new beating heart that conducted electrical impulses and pumped a small amount of blood.

Gene Therapy Technique: Water Droplets Produced By Electrospray Render Cells Permeable To External DNA
Japanese researchers have now developed a method which could represent a true alternative to conventional processes. The cells are “bombarded” with water droplets produced and accelerated by electrospray.

Pigs Raise Hopes for Blindness Cure
Pioneering transplants to restore the sight of people affected by the leading cause of blindness in the Western world could start in three years, after successful human cell implants in pigs.

Aastrom Announces First Patient Treatment With Autologous Stem Cell Therapy for Heart Failure
Aastrom Biosciences, Inc. has announced that the first patient has been treated with the Company’s autologous stem cell therapy for dilated cardiomyopathy.

StemCells, Inc. Provides Batten’s Clinical Trial Update
StemCells, Inc. has provided an update on the Company’s Phase I clinical trial of its proprietary HuCNS-SC(R) product candidate.

Gene Therapy Implants for Tendons
Freeze-dried implants loaded with gene therapy solution are being developed which may help repair injured and difficult-to-treat tendons.

Gene Therapy Cancers Prompt Design of Safer Virus
The announcement last month that a fifth child who received gene therapy for an immune system disease has developed leukemia was the latest blow to the field of gene therapy. But there’s new hope: The U.K. team running the trial reports this week that a safer formulation of the treatment can cure the disease in mice and should also work in people.

Nucleonics Initiates Hepatitis B Clinical Trial with Expressed Interfering RNA Therapeutic
Nucleonics, Inc. has announced that the company has begun treating patients in a Phase 1 human safety study of its experimental treatment for chronic Hepatitis B virus infection, NUC B1000.

Isolagen Inc. Completes Injections of Isolagen Therapy(TM) in Phase III Wrinkle and Phase II Full Face Studies
Isolagen(TM), Inc. has announced that injections have been completed in the pivotal Phase III multi-center, double-blind, randomized, placebo-controlled clinical trials evaluating the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles (Studies IT-A-005 and IT-A-006).

Interim Analysis Supports Continuation of Cell Genesys’ VITAL-1 Phase 3 Clinical Trial of GVAX Immunotherapy for Prostate Cancer
Cell Genesys, Inc. has announced that the Independent Data Monitoring Committee for VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, has completed a pre-planned interim analysis and has recommended that the study continue.


Human Embryonic Stem Cell-derived Cardiomyocytes Survive and Mature in the Mouse Heart and Transiently Improve Function After Myocardial Infarction
Researchers show the results of the first long-term (12 weeks) analysis of the fate of HESC-derived cardiomyocytes transplanted intramyocardially into healthy, immunocompromised (NOD-SCID) mice and in NOD-SCID mice that had undergone myocardial infarction.

Development of a Clinical Model for Ex Vivo Expansion of Multiple Populations of Effector Cells for Adoptive Cellular Therapy
The goal of these experiments was to develop a good manufacturing practice (GMP) method for expanding clinical-grade activated effector cells that mediate tumor cell killing through various mechanisms that could be infused into patients following high-dose chemotherapy and autologous stem cell transplant.


Cell Therapy Business Development Leader
Portland, OR (Invitrogen)

Irvine, CA (Global Biopharmaceutical Company)

Biomedical Equipment Technician
Los Angeles, CA (Cedars-Sinai Medical Center)

Quality Manager
Singapore (Singapore Cord Blood Bank)


Hybrid Embryo Research Approved
Stem cell scientist, Dr Lyle Armstrong has been given permission to use animal eggs in research which aims to lead to the development of new therapies for debilitating human conditions such as Parkinson’s Disease and strokes.

UK House of Lords Rejects Ban on Hybrid-Embryo Research
The vote came after an amendment to the Human Fertilisation and Embryology Bill was put forward in the House of Lords. But the motion was defeated by 268 votes to 96. When the legislation comes into force, scientists will be able to keep hybrid embryos alive for 14 days, but not implant them into a womb.

South Australian Ministers of Parliament are Being Lobbied to Reject Legislation Allowing Cloning of Human Embryos for Medical Research
The South Australian Parliament will be the first in the world to vote on the issue since the discovery, announced in November, of the creation of embryonic stem cells without using human eggs or embryos.

Lawmakers to Again consider Money for Stem Cell Research
Lawmakers will push to spend state money on embryonic stem cell research again this year now that a citizens initiative on the issue appears unlikely to get on the November ballot.

Stem Cell Agency to Offer $41M in Awards
An independent oversight committee with the state’s stem cell agency approved a measure Jan. 17 that will provide additional grant money to 14 young scientists pursuing stem cell research.


Plasticell Acquires Rights to Six Human Embryonic Stem Cell Lines
Plasticell has entered into an agreement with Axordia Ltd to exploit and market a panel of six human embryonic stem cell lines.

Regenetech Signs cellXpansion(TM) License with Korea Stem Cell Bank
Regenetech(R), Inc. is pleased to announce that it has signed a license covering the Republic of Korea for its proprietary stem cell expansion technology, cellXpansion(TM), with Korea Stem Cell Bank Co., Ltd.

Forticell in Stem Cell Collaboration with Korea’s CJ Corporation
Forticell Bioscience Inc. has signed a material transfer and technology evaluation agreement with South Korea’s CJ Corporation, which will use the company’s Fibrin MicroBeads technology for the extraction and expansion of mesenchymal-type stem cells from human umbilical cord blood.

International Stem Cell Corporation to Provide Corneal Epithelial Cells Differentiated from Its Parthenogenetic Stem Cells for Use in Photorefractive Keratectomy FDA Clinical Trials
International Stem Cell has announced that it will be providing corneal epithelial cells, derived from its Parthenogenetic stem cells and human keratinocytes, for use in Federal Drug Administration clinical trials aimed at creating a tissue transplant technology to improve photorefractive keratectomy.

PharmaCell Receives Official Licence as Registered Tissue Establishment
On December 11th, 2007 PharmaCell received news from the Dutch Health Care Authorities that it is now recognised as Registered Tissue Establishment.

LifeCell Gets AABB Accreditation News 
LifeCell has become the first and only cord blood stem cell bank in India to have AABB accreditation.

Dendreon Receives European Patent Covering PROVENGE(R) and Company’s ACI Platform Technology
Dendreon Corporation has announced that the company has been granted a broad European patent covering the company’s lead product candidate PROVENGE(R).

CryoLife Faces a $110M Suit, Pledges Vigorous Defense
CryoLife Inc. is once again being sued for allegedly providing contaminated cadaver tissue for a knee surgery.

Arteriocyte Receives $509,000 Grant from Cleveland Clinic’s Global Cardiovascular Innovation Center
The funding, received as part of a $60 million Third Frontier award to the Cleveland Clinic-led Global Cardiovascular Innovation Center initiative, will allow Arteriocyte to initiate Phase II clinical evaluation of its lead stem cell product to be used in chronic coronary ischemia.

Lifecell Plans for an IPO by July 2008
Lifecell is planning for an initial public offering within the next six months to expand its operations in the areas of stem cell therapy research and cord blood banking.


NIH Administrative Revisions for Human Pluripotent Stem Cell (hPSC) Research Using Non-Embryonic Sources (NOT-NS-08-013)

Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-08-035)

Request for Information (RFI): Notice of Request for Information on Cancer and Normal Tissue Acquisition and Processing Variables (NOT-CA-08-002)

Alzheimer’s Disease Research Centers (P50) (RFA-AG-09-001)


Human Cells, Tissues, and Cellular and Tissue-Based Products – CFR Correction

Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices; Proposed Rule



FDA Aims To Establish Overseas Staff Posts, Starting In China
FDA is considering posting staff overseas to perform inspections and foster relationships with foreign government counterparts and industry.

Food and Drug Administration’s Transition to the Federal Dockets Management System

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

Advisory Committees; Tentative Schedule of Meetings for 2008

Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices


Closer Ties On Medicines Safety Between European And Canadian Regulatory Authorities
The regulatory experts from the European Union and Canada will from now on be able to exchange confidential information about the authorisation and safety of medicines.

Committee Document – Biologicals & Vaccines Expert Advisory Group Summary Minutes (December 3, 2007)


14th ISCT Annual Meeting

May 17-20, 2008
Downtown Miami, Florida

Abstract Submission and Early Registration Deadline: January 31, 2008

Full details at: http://www.celltherapysociety.org

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