Volume 9.03 | Jan 28

Cell Therapy News 9.03, January 28, 2008
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Therapy Eases Muscular Dystrophy: This is the first time transplanted embryonic stem cells have been shown to restore defective muscles in mice models of the wasting disease, according to the study.

Gene Therapy’s ‘Side-Effect Free Pain Relief’: Millions could benefit from the discovery of a gene therapy that can deliver the pain relief benefits of morphine-like drugs without the side effects of abuse and addiction.


VIDEO – Derivation of Human Embryonic Stem Cells by Immunosurgery

Protein that Controls Hair Growth Also Keeps Stem Cells Slumbering
New research from Rockefeller University has unveiled the protein that puts the brakes on stem cell division and shows that stem cells may not need such guarded protection to maintain their potency.

Blood’s Hydrodynamics Used To Manipulate Stem, Cancer Cells
A tiny, implantable device has pulled adult stem cells out of a living rat with a far greater purity than any present technique.

Stem Cells Finally Found in Pancreas
An international team of researchers has finally managed to locate stem cells in the pancreas – in mice, at least.

Turning On Adult Stem Cells May Help Repair Bone
The use of a drug to activate stem cells that differentiate into bone appears to cause regeneration of bone tissue and be may be a potential treatment strategy for osteoporosis, according to a new report.

Stem Cells May Gradually Replace Antirejection Drugs For Kidney Transplant Patients
A team led by Joshua Miller, MD, a researcher at Northwestern University’s Feinberg School of Medicine, is working with Northwestern Memorial Hospital’s department of organ transplantation to enroll qualifying subjects in a new research study that seeks to transplants stem cells from a kidney donor’s bone marrow into the recipient, with the hope of gradually eliminating the need for anti-rejection drugs.

Surgeons Attempt to Repair Hearts with Stem Cell Injections
British scientists have been given the go-ahead to begin potentially ground-breaking experiments using injections of stem cells to repair patients’ damaged hearts. The team hopes to repair the organs of people who have suffered the most severe heart attacks.

Researcher Transplants Stem Cells to Try to Save Patients’ Legs
A Northwestern University Feinberg School of Medicine researcher has launched the first U.S. trial in which a purified form of subjects’ own adult stem cells was transplanted into their leg muscles with severely blocked arteries to try to grow new small blood vessels and restore circulation in their legs.

Adult Stem Cell Application Effective in Treatment of Peripheric Vascular Disease
Multipotent adult progenitor stem cells extracted from bone marrow, and known as MAPCs, have proved to be effective in the regeneration of blood vessel tissue and also in muscle tissue when treating peripheric vascular disease.

Alnylam Reports Positive Phase II Data for ALN-RSV01, an RNAi Therapeutic for the Treatment of Respiratory Syncytial Virus (RSV) Infection
Top-line results show that ALN-RSV01 was safe and well tolerated and demonstrated statistically significant anti-viral activity.

Apthera Files a Phase III Special Protocol Assessment with FDA for NeuVax(TM) in Early-Stage Breast Cancer Patients
Apthera, Inc. has announced that it has submitted a Phase III clinical protocol and statistical analysis plan for registration of its lead cancer therapeutic, NeuVax(TM) to the FDA for review under a Special Protocol Assessment.

MolMed Gets Regulatory Approval to Start a Phase III Trial in Italy of its TK Therapy for High Risk Acute Leukaemia
MolMed S.p.A., a biotech company focused on novel anti-tumour therapies, announced that the AIFA, the Italian Health authority, authorised the start in Italy of a Phase III trial (TK008) of MolMed’s TK cell therapy in patients affected by high risk acute leukaemias and receiving haematopoietic stem cell transplantation from a partially compatible family donor (haplo-HSCT).

Australian Girl Switched Blood Type After Transplant
An Australian girl spontaneously changed blood groups and adopted her donor’s immune system after a liver transplant, in what doctors treating her said Thursday was the first known case of its type.

ProtoKinetix’ AAGP(TM) More Than Doubles Stem Cell Recovery
ProtoKinetix reports that repeated tests have confirmed that the addition of AAGP(TM) to the cryopreservation process more than doubles the useable inventory of these very delicate and valuable cells.


Sensory Neuron Targeting by Self-complementary AAV8 Via Lumbar Puncture for Chronic Pain
The researchers report that gene transfer by lumbar puncture may be suitable for developing gene therapy-based treatments for chronic pain.

Beta Cells Can Be Generated from Endogenous Progenitors in Injured Adult Mouse Pancreas
Guided by the expression of Neurogenin 3 (Ngn3), the earliest islet cell-specific transcription factor in embryonic development, the researchers show that beta cell progenitors can be activated in injured adult mouse pancreas and are located in the ductal lining.


Cell Therapy Business Development Leader
Portland, OR (Invitrogen)

Irvine, CA (Global Biopharmaceutical Company)


UK Ministers Will Rethink Bill that Could Block Stem Cell Experiments
Tough new consent laws that would block cloning experiments involving embryonic stem cells are to be reviewed by the Government after a protest by leading scientists.

Pig Organs OK, But Not for Dinner
Most Australians would be happy to receive a life-saving organ from a pig or a cow as long as that animal was never destined for their dinner plate, a survey shows.


Venture Capital Investments Climb
Venture capital investments in U.S. startups climbed to a six-year high of $29.4 billion in 2007, raising hope that ample money will still be available to back promising new ideas even if the staggering economy falls into a recession.

StemCells, Inc. Enters Research Collaboration with Casey Eye Institute
StemCells, Inc. has announced that it has entered into a research collaboration with the Oregon Health & Science University Casey Eye Institute to evaluate the Company’s proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) as a potential treatment for retinal degeneration, a leading cause of blindness.

GenVec Announces Manufacturing Agreement for TNFerade(TM)
GenVec, Inc. has announced that it has entered into a manufacturing development agreement with Cobra Biomanufacturing Plc for TNFerade(TM), GenVec’s lead product candidate. The agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra’s facility in Oxford, United Kingdom.

ImmuneRegen BioSciences Signs Material Transfer Agreement with Celgene Cellular Therapeutics
ImmuneRegen BioSciences has announced it has finalized a Material Transfer Agreement with Celgene Cellular Therapeutics. As part of the agreement, ImmuneRegen will ship its potential therapeutic Homspera(R) to CCT for testing.

Biovest Secures Worldwide Exclusive License to Late-Stage Technology for Elimination of Transplant Rejection
Biovest International, Inc. has announced that it has secured the worldwide, exclusive license to Revimmune(TM) for the treatment and prevention of transplant rejection including rejection following a bone marrow transplant.

International Stem Cell Corporation Chairman Adds CEO Role
International Stem Cell Corporation has announced with great regret the untimely death of its CEO, Mr. Jeff Krstich. The Chairman of the Board, Kenneth C. Aldrich has assumed the additional responsibilities of Chief Executive Officer, effective immediately.

Dr. Charles A. Sims of California Cryobank’s Family Cord Blood Services Named to National Stem Cell Advisory Council
Family Cord Blood Services has announced that its co-founder and medical director Charles A. Sims, MD, has been appointed to the Department of Health and Human Services’ Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation.

HepaLife Announces Appointment of Dr. Christopher W. Kemp, Vice President of Research & Development
Christopher W. Kemp brings three decades of experience with cell biology, bioreactors, and vaccines, key to development of HepaLife’s novel, cell-based technologies.

MicroIslet Announces Management Change and Receives Working Capital Loan
MicroIslet Inc. has announced that Jonathan R. T. Lakey, PhD is no longer the Company’s president and chief scientific officer. Dr. Lakey remains a member of the Board of Directors.

Celprogen Launches Cancer Stem Cells
Celprogen Inc. has announced that they have successfully isolated and propagated 11 major cancer stem cells.


PHS 2008-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) (PA-08-050)

PHS 2008-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42]) (PA-08-051)


Regulatory Site Visit Training Program

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

Massachusetts Biotechnology Council’s Annual Luncheon – Slide Presentation



Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys

Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees


Advanced Therapies and EU Regulatory Issues Conference
February 22, 2008, London


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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