Volume 10.08 | Mar 9

Cell Therapy News 10.08, March 9, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Mount Sinai Hospital Researcher Makes Stem Cell Breakthrough: Mount Sinai Hospital’s Dr. Andras Nagy has discovered a new virus-free method of creating stem cells from a patient’s own skin.


Breakthrough Method Produces Parkinson’s Disease Patient-specific Stem Cells Free of Harmful Reprogramming Genes
Whitehead Institute researchers have developed a novel method to remove potential cancer-causing genes during the reprogramming of skin cells from Parkinson’s disease patients into an embryonic-stem-cell-like state.

Technique May Help Stem Cells Generate Solid Organs
Stem cells can thrive in segments of well-vascularized tissue temporarily removed from laboratory animals which can then be seamlessly reconnected to the animal’s circulatory system

McMaster Study Sheds Light on How Stem Cells Develop into Blood Cells
Messages sent within stem cells through a specific pathway can trigger them to specialize and develop into blood cells, according to new research from the McMaster Stem Cell and Cancer Research Institute.

University of Colorado at Boulder  Research Team Identifies Stem Cells that Repair Injured Muscles
A University of Colorado at Boulder research team has identified a type of skeletal muscle stem cell that contributes to the repair of damaged muscles in mice.

Massachusetts General Hospital to Use Genetics to Personalize Cancer Care
Cancer doctors at Massachusetts General Hospital plan within a year to read the genetic fingerprints of nearly all new patients’ tumors, a novel strategy designed to customize treatment.

Protein Complex Shown to Play Pivotal Role in Stem Cell Development in Two Stanford Studies
Scientists at the Stanford University School of Medicine have identified a protein complex important in controlling whether embryonic stem cells retain their ability to become any cell in the body.

BrainStorm’s Stem Cell Technology Demonstrates Efficacy in an Experimental Model of Parkinson’s Disease
Recent on-line publication by scientists demonstrate that human-derived adult Stem Cells may be induced to differentiate in vitro into neural-like cells and, once injected into the brain, improve impaired motor behavior in an experimental model of Parkinson’s disease.

Stem Cells Could Halt Osteoporosis, Promote Bone Growth
In a new study published researchers from the Research Institute of the McGill University Health Centre explain that tweaking mesenchymal stem cells with interferon gamma may promote bone growth.

Australian Scientists Develop Stem Cell Survival Technique
Researchers at the University of New South Wales have found a way to keep those cells alive so they can regenerate damaged tissue around them.

Pluristem Therapeutics Receives FDA Clearance to Begin First-In-Human?Placenta-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. announced recently that the US Food & Drug Administration has cleared the Company’s Investigational New Drug application to initiate a Phase I clinical trial for the treatment of Critical Limb Ischemia.

FDA Removes Clinical Hold From Aastrom Phase II IMPACT-DCM Clinical Trial
Aastrom Biosciences, Inc. recently reported that the U.S. Food and Drug Administration has removed the clinical hold from the Company’s U.S. Phase II IMPACT-DCM clinical trial and that patient enrollment would resume at the four initiated clinical sites.

Cardio3 BioSciences Treats Its First Patient with C-Cure, a Second-Generation Stem Cell Derived Therapy for Heart Failure
The patient, who was treated at the Cardiovascular Center of Aalst is participating in a Phase II/III clinical study to assess this second generation cell therapy in patients with heart failure.

TissueGene Announces Regulatory Allowance to Initiate Phase IIa Study of TG-C in South Korea for Osteoarthritis of the Knee
TissueGene, Inc. announced recently that its South Korean licensing partner Kolon Life Science, Inc. has received regulatory allowance from the Korea Food and Drug Administration (KFDA) to initiate a Phase IIa clinical trial of TissueGene-C in patients with severe osteoarthritis of the knee.


Treatment of Type 1 Diabetes with Adipose Tissue-Derived Stem Cells Expressing Pancreatic Duodenal Homeobox 1
This paper reports the derivation of insulin-producing cells from human or rat ADSC by transduction with the pancreatic duodenal homeobox 1 (Pdx1) gene.

Loss of Proliferation and Differentiation Capacity of Aged Human Periodontal Ligament Stem Cells and Rejuvenation by Exposure to the Young Extrinsic Environment
In this study, the researchers compared the proliferation and differentiation capacity of periodontal ligament stem cells obtained from young and aged donors.

Allogeneic Hematopoietic Stem-Cell Transplantation for Leukocyte Adhesion Deficiency
Allogeneic hematopoietic stem-cell transplantation offers the possibility of curative therapy, and with patient numbers at any individual center being limited, this study surveyed the transplant experience at 14 centers worldwide.

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Obama to Sign Stem Cells Order on Monday
President Barack Obama, who opposes limits on federal funding of stem cell research, will sign an executive order about stem cells on Monday, an administration official said on Friday.

Canadian Researchers Fear ‘Stagnation’ Under Tories
The Canadian Association of University Teachers, a lobby group that represents 65,000 staff at 121 colleges and universities, had planned to raise concerns over the government’s handling of research funding. But within moments, it became clear they wouldn’t get very far.

Obama Budget Greeted with Kudos Along with a Few Concerns
February was a great month for scientific research.  President Obama signed into law a stimulus package that provides over $25 billion for research – $10 billion of that for the NIH – and last week he pledged to double funding for cancer research and the NSF, starting with the 2010 budget.

Biotech Impact from Obama Plan Muted
Most of President Barack Obama’s budget will have little impact on large biotechnology companies, according to a Citi analyst, though several will have to prepare for potential competition from copies of their treatments.

Governor Of Kansas Tapped to Lead HHS
Kansas Governor Kathleen Sebelius recently accepted President Obama’s request to become his secretary of health and human services, stepping into a central role in the new administration’s ambitious effort to overhaul the nation’s health-care system.


Stemcells, Inc. to Aquire Cell-based Drug Discovery Platforms and Related Businesses of Stem Cell Sciences plc for US$4.8 Million
Stem Cell Sciences plc recently announced that it has entered into a definitive agreement with StemCells, Inc. for the sale of the Trading Subsidiaries of the Company and certain ancillary agreements, assets, properties and rights for a maximum total consideration of approximately US$4,849,000.

The California Institute for Regenerative Medicine Completes Briefing Visit to Stemedica Cell Technologies
Stemedica Cell Technologies is seeking approval from the California Department of Health to begin the production of adult stem cells for Phase I and II clinical trials at its facility in San Diego, US.

Dutch Stem Cell Company Cryo-Save Plans Expansion
Cryo-Save Group, the Netherlands-based stem cell company with a large Indian presence, plans to increase the number of stem cell donors in the country by opening more representative offices.

Genentech Gives Long-term Forecast to Rebuff Roche
Genentech Inc provided earnings and revenue growth projections for every year through 2018 as it aimed to demonstrate that the company is worth far more than Roche is willing to pay for it.

Profs Weigh Leaving Harvard over Allston Slowdown
The University’s plan to deal with the slowdown by re-assigning cellular biology laboratory space to stem cell researchers has raised concerns that basic biology research is being de-prioritized in the current financial crisis, according to several professors.

Clayton Rose Elected as HHMI Trustee
Clayton S. Rose, a Senior Lecturer at the Harvard Business School and 20-year veteran of J.P. Morgan & Co., has been elected a Trustee of the Howard Hughes Medical Institute.

Bone Biologics Wins New Patent for Recombinant Protein Process
Bone Biologics has received a US Patent Office notice of allowance of patent claims which protect a method of production for the UCB-1 recombinant protein that the company uses in the bone repair/regeneration technology in its lead product.


Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process (NOT-OD-09-054)

Delays in Grant Application Submission due to Snow Storm March 2009

Clarification to RFA-OD-09-003-Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1) (NOT-OD-09-061)


Draft Guidance for Industry – Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products— Content and Format



Is the FDA a Broken Agency?
Every few months, the Food and Drug Administration goes into fire-brigade mode, rushing to get control over another safety crisis. The agency that regulates products worth 25 cents of every dollar spent by U.S. consumers seems overwhelmed by its own mission.

Determination of Regulatory Review Period for Purposes of Patent Extension: ENDEAVOR, 9249-250 [E9-374]

Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products, 9250-251 [E9-372]

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