Volume 10.27 | Jul 20

Cell Therapy News 10.27, July 20, 2009
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Novel Stem Cell Trial Targets Heart Disease: Vanderbilt Heart and Vascular Institute recently enrolled its first patient in the FOCUS clinical trial in hopes of reversing damage to the patient’s cardiac muscle caused by heart disease. [Vanderbilt Heart and Vascular Institute, Vanderbilt University, Nashville]


Complimentary Wallchart: Guide to Hematopoietic Colonies Derived from Human Cord Blood Progenitors
Request your copy

Study Reveals Major Genetic Differences Between Blood and Tissue Cells
Research by a group of Montreal scientists calls into question one of the most basic assumptions of human genetics: that when it comes to DNA, every cell in the body is essentially identical to every other cell. [Department of Medicine, McGill University, Montreal]

Microscopic “Beads” Could Help Create “Designer” Immune Cells that Ignore Transplanted Organs
The future of organ transplantation could include microscopic beads that create “designer” immune cells to help patients tolerate their new organ. [Medical College of Georgia, Augusta]

Kids Shunned for Hair Loss Get Help from Their Own Stem Cells
Children with alopecia areata, a condition that causes extensive, sometimes complete hair loss, grew hair after being injected with stem cells drawn from their own scalp in a small study. [University of Cairo]


Correction of Murine Hemophilia a Following Nonmyeloablative Transplantation of Hematopoietic Stem Cells Engineered to Encode an Enhanced Human Factor VIII Variant Using a Safety-augmented Retroviral Vector
In this study, the researchers used the RMSinOFB vector to evaluate the efficacy of a newly bioengineered factor VIII (fVIII) variant (efVIII) toward successful treatment of murine hemophilia A. [Blood]

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Research and Development Scientist – Stem Cell Biology

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House Approves $2.99 Billion FDA Budget
The House on Thursday overwhelmingly approved a $373 million budget increase for the Food and Drug Administration, the largest boost in the agency’s history.


Connexon Creative Launches Cord Blood News
Cord Blood News is a weekly e-newsletter that keeps members of the cord blood community informed by providing the latest news from all areas of the field, including its science, research, policy, and business.

ImmunoCellular Therapeutics Retains Services of Torrey Pines Institute for Molecular Studies and Renowned Immunologist to Evaluate Lead Product Candidate
ImmunoCellular Therapeutics, Ltd. announced recently that it has retained the services of the Torrey Pines Institute for Molecular Studies in San Diego, CA, to evaluate the immunogenicity of peptides to target cancer stem cells relating to the Company’s lead product candidate ICT-121.

Yissum Licenses Stem Cell Technologies for Spinal Therapy to TheraCell, Inc.
Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., recently announced that it has licensed a novel package of stem cell related technologies to TheraCell, Inc., which will further develop and commercialize the technology for advanced regenerative medicine procedures such as spinal fusion.

Alnylam Announces Extension of RNAi Therapeutics Collaboration with Novartis
Alnylam Pharmaceuticals, Inc. announced recently that Novartis has elected to extend the company’s RNAi therapeutics collaboration for a fifth and final planned year, through October 2010.

Case Western Reserve University Receives $5M from Third Frontier Commission for the Center for Stem Cell and Regenerative Medicine
The Center for Stem Cell and Regenerative Medicine, comprised of Case Western Reserve University, Cleveland Clinic, University Hospitals, and Athersys, Inc. has received $5 million from Ohio’s Third Frontier Commission under the Research Commercialization Program.

UK to Channel EUR $21M into Regenerative Medicine
The UK’s Office for Life Sciences will invest EUR $21M into the development of stem cell therapies via its “Life Sciences Blueprint” program.

Cytori’s Celution(R) 700 System to be Regulated as a Medical Device by U.S. FDA
Cytori Therapeutics was informed by the U.S. Food and Drug Administration that the Celution(R) 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act.

Canadian Biotechnology Feels the Pinch as Funds Dry Up
Canada will lose up to 7,000 high-skilled research and development jobs within one year if short-term financing cannot be obtained, results from the most recent BIOTECanada survey show

Cellular Dynamics International In-Licenses Key Patent Portfolio for Using Stem Cell-Derived Cells in Drug Testing
Cellular Dynamics International recently announced that it has exclusively in-licensed a US-issued patent portfolio on optimizing the stem cell differentiation selection process and on using heart cells in drug testing.

Cytori Expands Patent Protection for the Celution(R) System and Uses for Adipose Derived Stem and Regenerative Cells
Cytori Therapeutics, Inc. recently received a Notice of Allowance from the U.S. Patent and Trademark Office related to uses of the Celution(R) System for the treatment of bone related disorders.

Aastrom Biosciences Receives Notification That NASDAQ to Continue Temporary Suspension of Certain Continued Listing Requirements
Aastrom Biosciences, Inc. announced that the Company received Issuer Alert #2009-004, which states that NASDAQ is continuing the temporary suspension of the rules requiring a minimum $1.00 per share closing bid price and a minimum market value of publicly held shares for approximately two additional weeks.


Status of Applications and Awards under the New NIH Guidelines for Human Stem Cell Research (NOT-OD-09-123)

Clarification, Institutional Clinical and Translational Science Award (U54), RFA-RM-09-004 (NOT-RM-09-016)

NHLBI Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral MD/PhD Fellows (F30) (PA-09-232)


2009 CBER Foreign Regulators Seminar



Guidance for Institutional Review Boards, Frequently Asked Questions-Institutional Review Board Registration; Availability

Food and Drug Administration Regulation and Licensure of Whole Blood and Blood Components, Including Source Plasma; Public Workshop; Request for Comments


Guidance on the Maintenance of Regulatory Compliance in Laboratories that Perform the Analysis or Evaluation of Clinical Trial Samples

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