Volume 7.47 | Dec 4

Volume 7.47, December 4, 2006
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Stem Cell Cure Hope for Back Pain: A patient’s own stem cells could soon be used to cure chronic back pain.


Second Cancer Risk Follows Stem Cell Transplants
Survivors of blood-related cancers who underwent hematopoietic stem cell transplants (HSCT) face a significant long-term risk for developing a second cancer, particularly if they were older at the time of transplant or received stem cells from a female donor.

MannKind Corporation Announces Clearance of IND for MKC1106-PP Immunotherapy in Solid Malignancies
The clearance of the IND means that the Company may now proceed with the initiation of its Phase 1 clinical trial – a multicenter, open label, clinical trial of immune response, safety and tolerability of a DNA vector with two synthetic peptides in subjects with solid malignancies, in a plasmid prime-peptide boost treatment.

Colon Cancer Vaccine Shows Promise
British researchers say they’ve developed a vaccine that stimulates the immune system to fight colorectal cancer cells.

Novel Suicide Gene Therapy Used to Treat Malignant Brain Tumors
Physicians and researchers in the Methodist Neurological Institute (NI) are studying the use of a novel combination of radiation and suicide gene therapy to treat typically stubborn malignant brain tumors.

T Cell Therapy Helpful in Metastatic Melanoma
Results of a phase I study indicate that adoptive T-cell therapy using antigen-specific CD8+ T cells prompts immune responses in some patients with metastatic melanoma.

Stem Cell Therapy International Reports the Successful Treatment of a Stroke Patient With Their Proprietary Stem Cell Transplantation Therapy
Stem Cell Therapy International, Inc. announced the successful treatment of a stroke patient from the United States with its stem cell transplantation therapy protocol conducted at one of their affiliate clinics in Kiev, Ukraine.

Study of Gene Transfer for Erectile Dysfunction Shows Promise
The first human study using gene transfer to treat erectile dysfunction (ED) shows promising results and suggests the potential for using the technology to treat overactive bladder, irritable bowel syndrome and asthma.

Northwest Biotherapeutics Receives Institutional Review Board Approval to Accrue Patients in Phase II Brain Cancer Trial
Northwest Biotherapeutics announced that it has received Institutional Review Board (IRB) and contractual approval from the Henry Ford Hospital in Detroit, Michigan to proceed with the Company’s Phase II trial of its personalized therapeutic cancer vaccine, DCVax®-Brain, in patients with newly diagnosed Glioblastoma multiforme (“GBM”).

Face Transplant Woman Can Smile
The recipient of the first partial face transplant has recovered so well she can go out without people noticing her scars, her surgeon has said.

New Rules Proposed to Catch Science Fraud
A panel of scientists and journal editors has advised the high-profile research journal Science to apply tougher standards before publishing certain research.


Phase I Study of Adoptive T-Cell Therapy Using Antigen-Specific CD8+ T Cells for the Treatment of Patients With Metastatic Melanoma
The adoptive transfer of in vitro generated tumor antigen-specific cytotoxic T lymphocytes (CTL) provides a promising approach to the immunotherapy of cancer. A phase I study was conducted to test the feasibility, safety, and survival of adoptively transferred Melan-A–specific CTL lines in melanoma patients.


Vetoed Stem Cell Bill Likely To Be Revived
House Speaker-in-waiting Nancy Pelosi expects to reintroduce a bill to increase federal funding of embryonic stem cell research in the first 100 hours of the next Congress. The bill, previously vetoed by President George W. Bush, is expected to bring heated debate, and it is uncertain whether Democrats will have enough votes to override an another presidential veto. 

Early Debate Gives Supporters of Cloning Lead
Supporters of a bill that would legalise therapeutic cloning in Australia are marginally ahead of its opponents after the first day of a long-awaited House of Representatives conscience debate.

Florida Supreme Court to Decide Fate of Stem Cell Research Funding
The Florida Supreme Court is to decide the fate of two proposed state constitutional amendments to provide or ban state funds for embryonic stem cell research. An amendment that would prohibit the funds has reached the high court less than a month after justices received an opposing amendment requiring a $20 million appropriation for the research.


Progenitor Cell Therapy Expands Contract Process Development Capacity
Progenitor Cell Therapy LLC (PCT) announced today a significant expansion of its process development contract service capabilities with the completion of new laboratory space and the addition of key staff at its Mountain View, California facility.

ImmunoCellular Therapeutics Completes Licensing Transaction for Cancer Vaccine Therapy Technology
ImmunoCellular Therapeutics, Ltd. announced today that it has entered into an exclusive, worldwide license agreement with Cedars-Sinai Medical Center covering Cedars-Sinai’s technology for cellular therapies, including dendritic cell-based vaccines for brain tumors and other cancers, as well as other neurodegenerative disorders.

ReNeuron and CellSeed Announce Collaboration Using ReNcell(TM) Liver Cell Lines
ReNeuron Group plc and CellSeed Inc have announced the signing of a collaboration agreement to develop novel, patented liver cell culture systems for drug safety screening in the pharmaceutical industry.

CHA Medical Group, Led By Kwang Yul Cha, Build South Korea’s Largest Stem Cell Institute In Pangyo Techno Valley
The institute, when completed, will be the nation’s largest stem cell institute, equipped with stem cell research, treatment and educational facilities.

MicroIslet Expands Expertise in Product Development
MicroIslet has appointed Mohammad A. El-Kalay, Ph.D. as Vice President of Research and Development, replacing Ronnda L. Bartel, Ph.D., and has added William Soo Hoo, Ph.D. to its scientific roster as Director of Cell Biology.


NIH R01 Grant Applications Go Electronic
Beginning with the February 5, 2007 standard receipt date and beyond, the National Institutes of Health (NIH) will require applicants to submit all Research Project Grant R01 applications electronically — no paper applications will be accepted.

Delays in Grant Application Submission due to Winter Storms (NOT-OD-07-023)

Correction for RFA-DK-06-004: Biomarker Development for Diabetic Complications (R21) (NOT-DK-06-024)

Notice of NIGMS’ Intent to Withdraw from PA-07-026 (Developmental Biology and Regeneration of the Liver [R01]) (NOT-GM-06-117)


Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events

Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors

All new CBER information can be reached from the What’s New page at What’s New Page



Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

Blood Products Advisory Committee; Notice of Meeting

FDA Acting Commissioner Andrew von Eschenbach’s speech at the Inaugural International Summit – “The Challenges of Regulation in the World of Molecular Medicine”

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update


Therapeutic Goods Committee 29th Meeting (September 7, 2006) Meeting Report


Call for Abstracts
On-line abstract submission for the 2007 ISCT Annual Meeting is now available through the ISCT Website. 
Submission deadline: February 16, 2007

ISCT Membership
Renew your ISCT Membership for 2007 now!
Not a member?  Visit the ISCT website to learn about the benefits of membership.

AABB-ISCT Cellular Therapy Audioconference Series

Profiled Journal

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Current Volume: Volume 8 Number 6 / December 2006

Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes basic and applied research with hematopoietic and non-hematopoietic stem cells, immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.

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