Volume 9.25 | Jun 30

Cell Therapy News 9.25, June 30, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

New Source of Heart Stem Cells Discovered: Researchers at Children’s Hospital Boston are continuing to document the heart’s earliest origins. Now, they have pinpointed a new, previously unrecognized group of stem cells that give rise to cardiomyocytes, or heart muscle cells. These stem cells, located in the surface of the heart, or epicardium, advance the hope of being able to regenerate injured heart tissue.

Nerve Cells Derived from Embryonic Stem Cells and Transplanted into Mice May Lead to Improved Brain Treatments: Scientists at the Burnham Institute for Medical Research have, for the first time, genetically programmed embryonic stem cells to become nerve cells when transplanted into the brain. The research, an important step toward developing new treatments for stroke, Alzheimer’s, Parkinson’s and other neurological conditions showed that mice afflicted by stroke showed tangible therapeutic improvement following transplantation of these cells. None of the mice formed tumors, which had been a major setback in prior attempts at stem cell transplantation.


HepaLife Develops New Liver Stem Cell Lines for Bioartificial Liver Device
HepaLife Technologies, Inc., recently announced the development of two new derivative cell lines from the Company’s patented PICM-19 liver stem cells for use in HepaLife’s first-of-its-kind bioartificial liver device currently under development for the treatment of human liver failure.

Canadian Scientists Deliver on Promise of Stem Cell Therapy for Lung Disease 
Two Quebecers suffering from pulmonary hypertension, a rare but debilitating lung disease, were treated in Montreal with their own gene-modified stem cells.  This experimental treatment was administered at the Jewish General Hospital’s Centre for Pulmonary Vascular Disease.

UGA Research May Lead to Safer, More Effective Gene Therapy
The potential of gene therapy has long been hampered by the risks associated with using viruses as vectors to deliver healthy genes, but a new University of Georgia study helps bring scientists closer to a safe and efficient gene delivery method that doesn’t involve viruses.

Umbilical Cord Blood Cell Transplants May Help ALS Patients
A study at the University of South Florida has shown that transplants of mononuclear human umbilical cord blood cells may help patients suffering from Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease. A disease in which the motor neurons in the spinal cord and brain degenerate, ALS leaves its victims with progressive muscle weakness, paralysis and, finally, respiratory failure three to five years after diagnosis.

Ronin Provides Alternate Pathway to Pristine Embryonic Stem Cells
Like the masterless samurai for whom it is named, the protein Ronin chooses an independent path, maintaining embryonic stem cells in their undifferentiated state and playing essential roles in genesis of embryos and their development.

Scientists Discover How An Injured Embryo Can Regenerate Itself
How exactly is the half embryo able to maintain its tissues and organs in the correct proportions despite being smaller than a normal sized embryo? Present research from scientist Prof. Naama Barkai and her colleagues developed a mathematical model to describe interactions that occur within genetic networks of an embryo.

Stem Cell Treatment in Clinical Trial at Texas Heart Institute at St. Luke’s
Scientists at the Texas Heart Institute at St. Luke’s Episcopal Hospital will use special stem cells to treat heart attack patients in the first clinical trial of its kind. Stem cells from healthy donors will be grown in cultures and injected into patients’ hearts.

Living Cell Technologies Confirms Insulin Delivery from Implants in Diabetes Clinical Trial
Living Cell Technologies Limited recently reported that patients in the DiabeCell phase I/IIa diabetes clinical trial had porcine insulin in their blood samples providing additional scientific confirmation that implants of DiabeCell actively produce insulin and directly contribute to clinical benefit. 

Genta Updates Progress of its Phase 3 Trial of Genasense in Patients with Advanced Melanoma
Genta Incorporated announced the presentation of a progress update from an ongoing Phase 3 trial of Genasense (oblimersen sodium) Injection, the Company’s lead oncology product, in patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta’s prior randomized trial of Genasense combined with dacarbazine in patients identified by a biomarker who have not previously received chemotherapy.


Regenerative Effect of Neural-Induced Human Mesenchymal Stromal Cells in Rat Models of Parkinson’s Disease
Human bone marrow multipotent mesenchymal stromal cells, because of their capacity of multipotency, may provide an unlimited cell source for cell replacement therapy. The purpose of this study was to assess the developmental potential of hMSC to replace the midbrain dopamine neurons selectively lost in Parkinson’s disease.

Bone Marrow Mesenchymal Stem Cell Transplantation Improves Ovarian Function and Structure in Rats with Chemotherapy-Induced Ovarian Damage
Many investigations have reported that mesenchymal stem cell transplantation can ameliorate the structure and function of injured tissues. The purpose of this study was to explore the therapeutic potency of MSC transplantation for chemotherapy-induced ovarian damage.

A Novel Method for Generating Xeno-Free Human Feeder Cells for Human Embryonic Stem Cell Culture
Long-term cultures of human embryonic stem cells require a feeder layer for maintaining cells in an undifferentiated state and increasing karyotype stability. We demonstrate that animal-free HFFs do not enter senescence within 55 passages when cultured in animal-free conditions. This methodology offers alternative and completely animal-free conditions for hES cell culture, thus maintaining hES cell morphology, pluripotency, karyotype stability, and expression of pluripotency markers.

iPS Cells: A More Critical Review
Over the past 20 months, reports claiming the generation of induced pluripotent stem cells with characteristics identical to those of embryonic stem cells from nonembryonic tissue have captured great attention in both the scientific community and the general public.  This review calls into question the validity of many claims made in these reports-claims that have led to the rapid and premature acceptance of using iPS cells as a viable alternative to using normal stem cells for regenerative therapy.


GMP Facility Quality Assurance

Product Manager

Lead Clinical Laboratory Scientist

Adult Stem Cell Biology Researcher

Operations Manager

Market Development Manager – Americas

Field Applications Specialist

Product Development Associate

Human Application Laboratory Opportunities


Private Funding Proposed for Stem Cell Grants
New Jersey assemblyman Neil M. Cohen, D-Union, proposed a measure this week to set up a fund into which banks or investment firms could deposit $500 million for stem cell research grants. If the researchers don’t repay the loans, lenders would be entitled to state tax credits.

Few Issues To Make it On Ballot
Michigan voters, who once faced a daunting list of potential ballot questions this November, may decide only a handful of issues after all. This constitutional amendment would strike the ban on embryonic stem cell research, which is now restricted to existing stem cell lines imported from other states. Backers say Michigan’s strict laws put this state at a disadvantage for important biomedical research and jobs associated with it.


Preparing For (and Avoiding) the Courtroom
Intellectual property is often the most valued asset of biotech firms, especially startups. Two IP lawyers offer guidance on avoiding suits altogether, when to settle them and when to fight.

Pfizer Provides Early Funding for Stem Cell Biotech
EyeCyte, Inc., an early stage stem/progenitor cell-based ophthalmology research and development company, recently announced that it has secured its Series A funding through an agreement with Pfizer. The financing will fund the company into 2010 and will be primarily used to drive product development of the company’s initial clinical target, diabetic retinopathy.

Invitrogen Partners With International Regulome Consortium to Advance Stem Cell Research for the Development of Life Saving Therapies
The International Regulome Consortium announced recently it has signed a non-binding letter of intent with Invitrogen Corporation to develop tools for stem cell research that will aid in the development of new therapies for some of the world’s most debilitating diseases. The agreement was signed here recently at the annual meeting of the Biotechnology Industry Organization.

BioTime, Inc. and Embryome Sciences, Inc. Sign Agreement With International Stem Cell Corporation to Provide Unique Human Stem Cell Lines for Research Use
BioTime, Inc., and BioTime’s wholly-owned subsidiary Embryome Sciences, Inc., have signed a manufacturing and distribution agreement with International Stem Cell Corporation through its wholly-owned subsidiary Lifeline Cell Technology to jointly produce and distribute hundreds of new standardized human and animal stem cell lines, along with corresponding data and reagents. The mutual goal is to provide the “picks and shovels” for scientists mining the stem cell field for therapeutics in the emerging field of regenerative medicine and pharmaceutical drug discovery.

ReNeuron Secures £2.5 Million Financing
ReNeuron Group plc recently announces that it has secured £2.5 million of further financing from its principal existing investors by way of a subscription for a series of new Secured Loan Notes constituted by the Company.

Osiris Therapeutics receives $2 Mil for Clinical Progress of Stem Cell Therapy for Juvenile Diabetes
Osiris Therapeutics, Inc. said Wednesday that it received $2 million in milestone payments for progress made in an ongoing mid-stage trial of a stem cell therapy for type 1 diabetes.

U.S. Patent Office Issues Certificates to Uphold WARF Stem Cell Patents
The United States Patent and Trademark Office has issued Reexamination Certificates for the two most important base embryonic stem cell patents held by the Wisconsin Alumni Research Foundation.

RegeneRx Biopharmaceuticals, Inc. Receives First Patent on T Beta 4’s Ability to Repair Lung Damage Resulting from Infections and Other Disorders
RegeneRx Biopharmaceuticals, Inc. announced recently that it has received an Australian patent for the use of TB4, its derivatives, analogues and fragments, to repair pulmonary damage resulting from pulmonary microbial infections. The patent expires in 2023.

European Patent Office Hears Dispute on Human Stem Cells
A European Patent Office tribunal in Munich heard a dispute Tuesday on whether a method of growing embryonal human stem cells can be patented, but gave no date for its decision on the controversial case. US scientist James Thomson, who in 1998 was the first in the world to cultivate such stem cells, is appealing to EPO’s highest board over the refusal to grant a patent in the European Union for the so-called WARF stem cell.


Exploratory/Developmental Grant for Complementary and Alternative Medicine (CAM) Studies using Cells, Tissues, and Animal Models of Disease (R21)


Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “lookback.”



Device Recall Associated with Therapy Tissue Ablation: Ablation System – St Jude Medical – Livewire TC 402196


Personal Genomics Companies Rush to Comply with California Regulations
In the wake of consumer complaints and similar action from New York State, California last week issued warning letters to 13 providers of genetic tests to California residents. “We’re concerned about the accuracy [of the tests]. Do they even have a license? Should they be offering these tests to California residents?”