Volume 8.06 | Feb 19

Volume 8.06, February 19, 2007
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Mice Cloned from Skin Cells: Healthy and viable mice that survive until adulthood have, for the first time, been cloned from adult stem cells.

Human Stem Cell Transplants Repair Rat Spinal Cords: Human nerve stem cells transplanted into rats’ damaged spinal cords have survived, grown and in some cases connected with the rats’ own spinal cord cells in a Johns Hopkins laboratory, overturning the long-held notion that spinal cords won’t allow nerve repair.


Brain Creates New Nerve Cells
Researchers have discovered a type of brain cell that continuously regenerates in humans.

Adult Stem Cells Decide the Fate of Their Daughters
Researchers found that intestinal stem cells make important decisions about their fate by communicating directly with their daughter cells, instructing them to become one of two possible cell types.

Males More Prone to Cloning
A new study shows that mouse embryos created from male adult cells were more than three times as likely to develop to term as those created from female adult cells.

New Hope For Regenerative Medicine: Hematopoietic Reconstitution With Uniparental Stem Cells
Researchers report on their success in using uniparental embryonic stem cells to replace blood stem cells in mice. Uniparental embryonic stem cells are an appealing alternative source of patient-derived embryonic stem cells, as they have several advantages over embryonic stem cell lines generated by somatic cell nuclear transfer (also known as therapeutic cloning).

Researchers Discover "Sticky" Proteins Fuse Adult Stem Cells to Cardiac Muscle, Repairing Hearts
Cardiologists are increasingly using adult stem cells in clinical trials to repair hearts following heart attacks, but no one has understood how the therapy actually works. Now, in animal experiments, researchers at The University of Texas M. D. Anderson Cancer Center have deconstructed the process, describing how the stem cells fuse with heart muscle cells to create new cells that repopulate the ailing organ.

BrainStorm Cell Therapeutics Initiates Stem Cell Safety Study in Primates for Parkinson’s Disease
The study utilizes BrainStorm’s proprietary adult stem cell technology which has shown efficacy in animal models of Parkinson’s Disease in previous pre-clinical trials. In those studies, human-bone-marrow-derived stem cells were differentiated into astrocyte-like cells (supporting cells) and transplanted into mice and rats brains. The engrafted cells survived, kept their function and significantly improved the motor symptoms of Parkinson’s Disease animal models over a long period of time.

Human Adult Stem Cells Regenerate Muscle
Italian scientists have found human adult stem cells taken from blood vessels can regenerate muscle in a mouse model of muscular dystrophy.

Doctors Try New Techniques To Regrow Human Tissue
Five soldiers at a military base in Texas are about to participate in a remarkable test to see if they can regrow portions of fingers they lost in the war in Iraq. Doctors plan to treat them with a fine powder called extracellular matrix, harvested from pig bladders.

Stem Cell Breakthrough
A first step has been made towards curing muscular dystrophy with stem cells.

Osiris Announces Top-Line Interim Results for Stem Cell Trial for Knee Repair
Osiris Therapeutics, Inc. has announced six-month interim results in its evaluation of CHONDROGEN(TM) for the regeneration of meniscus in the knee. A total of 55 patients were treated in the Phase I/II, double-blind study evaluating the safety and exploratory effectiveness of CHONDROGEN, a preparation of adult stem cells formulated for direct injection into the knee.

Aastrom’s U.S. Clinical Investigator to Report Interim Data on Long Bone Fracture Repair Trial
Aastrom Biosciences, Inc. has announced that 90% of the patients who have completed the 12 months post-treatment follow-up in the Company’s U.S. Phase I/II multi-center clinical trial evaluating the use of Tissue Repair Cells (TRCs) in the treatment of severe long bone fractures had multiple bone bridges, evidence of bone regeneration.

First Patients Undergo Surgery in Northwest Biotherapeutics’ Phase II Brain Cancer Trial
Northwest Biotherapeutics, Inc. has announced that the first two patients in its pivotal Phase II clinical trial have undergone surgery for newly diagnosed Glioblastoma multiforme (GBM), which is the first step in the preparation of the Company’s DCVax(R)-Brain treatment.

Stem Cells Used in Cosmetic Surgery
Scientists in Japan claim to be able to increase the size of a woman’s breasts using fat and stem cells.

Flawed Stem Cell Data Withdrawn
It is one of the best-known stem cell papers in the past five years, describing adult cells that seemed to hold the same promise as embryonic stem cells. Now, following inquiries by New Scientist, some of the data contained within the papers is being questioned.


Mice Cloned From Skin Cells
The researchers’ findings reveal skin as a source of readily accessible stem cells, the nuclei of which can be reprogrammed to the pluripotent state by exposure to the cytoplasm of unfertilized oocytes.

Extensive Neuronal Differentiation of Human Neural Stem Cell Grafts in Adult Rat Spinal Cord
This article reveals that restoration of spinal cord circuitry in traumatic and degenerative diseases may be more realistic than previously thought, although major challenges remain, especially with respect to the establishment of neuromuscular connections.


California Board Approves $45 Million in Stem Cell Grants
California’s stem-cell institute approved nearly $45 million in research grants to about 20 universities and other research laboratories on Friday as it awaits a state appeals court decision on whether the agency is unconstitutional.

Appeals Court Hears California Stem Cell Agency Lawsuits
A three-judge appellate court panel appeared skeptical that California’s $3 billion stem cell agency was unconstitutional or that its managers had any conflicts of interest, as lawyers backed by anti-abortion groups and tax advocates argued Wednesday.

Iowa Stem Cell Bill Squeaks Through Senate
With no votes to spare, the Iowa Senate today approved legislation that would allow medical researchers in Iowa to create embryonic stem cells through cloning.

Florida, Minnesota, Nebraska Take Actions On Human Cloning, Stem Cell Research-Related Proposals
This article highlights recent news of state actions on human cloning and stem cell research.


The Stem Cell Meeting
March 12 – 13 at San Francisco’s Mission Bay Conference Center at UCSF.
The only international business, policy and economic forum for science and business professionals working at the leading edge of stem cell and regenerative medicine development.  Cell Therapy News readers receive a special discount. To register, please go to www.thestemcellmeeting.com and click “Registration.”  Select “Special” from the Attendee Type drop down menu. Click “Register Now” and enter access code “2SCSPC”. If you have any questions, please contact registration at 800-549-1735; or [email protected].

Stem Cell Sciences and Celogos Sign a Licensing Deal on Autogenous Myoblast Transplantation For Urinary Incontinence Therapy
Under this license, Celogos has granted Stem Cell Sciences exclusive rights to commercialize in Japan therapeutic products developed under Celogos’ patent and know-how related to myoblast implantation.

ViaCell Announces ViaCyte Manufacturing Agreement with Invitrogen
ViaCell, Inc. announced it has entered into an agreement with Invitrogen to manufacture its ViaCyteSM media. ViaCyte is ViaCell’s investigational product offering for use during assisted reproductive technology. The media manufactured by Invitrogen will be used in ViaCell’s pivotal clinical trial to evaluate the cryopreservation and thawing of human oocytes.

Cell Therapeutics, Inc. Spin-off to Use Proprietary Recombinant Genetic Technology to Develop Novel Biopharmaceuticals, Follow-on Biologics and to Deliver siRNA
Cell Therapeutics, Inc. has announced that it plans to form a new spin-off company, Aequus BioPharma, Inc. to develop a Genetic Polymer(TM) technology that was created at CTI to speed the manufacture, development and commercialization of novel biopharmaceuticals including follow-on biologics or so-called biosimilars.

Bone Biologics Selects Cytovance(R) Biologics for cGMP Manufacturing of its Breakthrough Bone and Cartilage Regeneration Therapy
Cytovance(R) Biologics LLC has announced the addition of Bone Biologics, Inc. to its diverse and growing client portfolio. Bone Biologics has selected Cytovance for process development and cGMP manufacturing of its breakthrough recombinant protein for spinal fusion surgery.

Regeneration Technologies and Wright Medical Group Enter Agreement to Develop Advanced Biomaterial Implants for Foot and Ankle Surgeries
Under the agreement, Wright Medical will design and distribute the implants, while Regeneration Technologies will develop, manufacture and supply Wright’s designs.

United States and United Kingdom Stem Cell Banks to Team Up
Leaders of national embryonic stem cell banks in the United States and the United Kingdom have pledged to work together to promote research, create international standards and more efficiently distribute each other’s cells.

Cytori to Commercialize Stem Cell Therapy for Breast Reconstruction in Cancer Patients in Europe in Early 2008
Cytori Therapeutics intends to commercialize its Celution(TM) System in Europe in early 2008 for use in reconstructive surgery in breast cancer patients following a partial mastectomy (lumpectomy), in advance of the original anticipated timeline.

Copernicus to Receive Increased Support from Cystic Fibrosis Foundation Therapeutics for Further Development of its Non-Viral Gene Therapy for Cystic Fibrosis
Copernicus Therapeutics, Inc. announced today it will receive up to $5.2 million from Cystic Fibrosis Foundation Therapeutics, Inc. to support continued development of a potential gene therapy for cystic fibrosis. This continued funding is a result of satisfactory progress shown in 2006 and represents a significant increase in funding over that received in 2006.

Bioheart Plans $35 Million IPO
Bioheart Inc. has registered for a proposed initial public offering of stock with the U.S. Securities and Exchange Commission.

Advanced Cell Technology Names Noted Biotech Industry Executive Dr. Pedro Huertas, as Chief Development Officer to Manage the Clinical Development and Regulatory Approval Process for its Stem Cell-Based Therapeutic Products
Pedro Huertas, MD, PhD will be responsible for overseeing the development of the Company’s programs to create novel stem cell-based therapeutics, from the pre-clinical stage through clinical development and regulatory approval.

InNexus Biotechnology Appoints Chief Scientific Officer
InNexus Biotechnology Inc. has appointed Dr. Heinz Kohler as Chief Scientific Officer.


Delays in Grant Application Submission due to Winter Storms – February 2007 (NOT-OD-07-046)

Observations from NIH’s Targeted Site Reviews on Financial Conflict of Interest (NOT-OD-07-048)


FDA HCT/P Inspection Experience: Analysis by Area and General Update – Mary Malarkey

Quality Program, CAPA and Audits – Mary Malarkey

Embryonic Stem Cell-based Therapies: US-FDA Regulatory Expectations – Donald W. Fink, Jr., Ph.D.

The Tenth US – Japan Cellular and Gene Therapy Conference on Nanobiotechnology

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)

Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567; Correction


ISCT 2007-Register Now!
13th ISCT Annual Meeting
June 24-27, 2007
Sydney, Australia

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ISCT Membership
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Profiled Journal

Robert Weinstein, MD
Chief, Division of Transfusion Medicine, UMass Memorial Medical Center, Worcester, MA.

The Journal of Clinical Apheresis provides the world’s premier source of current information in the field of apheresis. The Journal presents work in all aspects of basic and clinical research, practical applications, emerging technologies and regulation in apheresis and related fields including hematology, nephrology, neurology, rheumatology, transplantation, cellular therapies, blood banking, transfusion medicine, and others.

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