clinical trials

Tougher FDA bars seven researchers from new studies

John Carroll — Tue, 10 Jun 2008 08:40:18 -0400

So far this year a more vigilant FDA has barred seven physicians from conducting medical research work. The actions equal the number of actions taken by the agency over the past three years.

The FDA has come under increasing pressure to take action against researchers accused of fraud. Critics have maintained that the agency often takes years before moving to bar a researcher from new studies. And one of the seven barred in the first half of this year was Maria Anne Kirkman Campbell, a researcher who admitted five years ago to research fraud in a Sanofi-Aventis study. An FDA spokesperson says the agency has adopted a new, tougher time line on such actions and is in the process of hiring new staffers to beef up enforcement.

- read the report in Pharmalot

ALSO NOTED: ESC therapies in race to the clinic; Ultraviolet light used to target tumors; Scientists find chemical trigger to P

Tue, 06 Nov 2007 06:59:58 -0500

Stem Cell Research

Researchers at Geron and Advanced Cell Technology are jockeying to begin the first human clinical trials of embryonic stem cell therapies. Geron plans to file for regulatory approval by the end of this year, with ACT saying it will file its application by the middle of next year. Report

Orthopedic researchers at Jefferson Medical College have for the first time found stem cells in the intervertebral discs of the human spine, suggesting that such cells might someday be used to help repair degenerating discs and remedy lower back and neck pain. Release

According to a new study published in Circulation Research, University of Missouri-Columbia researchers say that a muscular dystrophy patient should be able to maintain a normal lifestyle if only 50 percent of the cells of their heart are healthy. Release

India's first clinical research facility for stem cells and regenerative medicine will be opened in Hyderabad by the Centre for Cellular and Molecular Biology and Nizam's Institute of Medical Sciences. Report

Carnegie Mellon University's Stefan F. Zappe is using adult neural stem cells to develop a new stem cell-based drug delivery therapy that may ultimately help treat a variety of inherited genetic disorders like Hunter syndrome. Release

Cancer Research

Colin Self and Stephen Thompson of Newcastle University have developed a technique that uses ultraviolet light to activate antibodies in a targeted attack on tumors. Report

A team of scientists at Albert Einstein College of Medicine of Yeshiva University in New York City say that knocking out the virus responsible for a number of cancers could be the most effective approach in preventing the disease. Both liver and cervical cancer are caused by viruses. And the scientists have been developing radioimmunotherapy to kill the viruses. Report

VIB scientists connected to the Katholieke Universiteit Leuven, in collaboration with the Flemish biotech company ThromboGenics, have been studying the anti-cancer action of anti-PLGF. Release

U.S. researchers have found a mechanism to predict survival in women aged 65 and older with early stage lung cancer. The new study, published on Thursday in the medical journal Cancer Research, links high levels of aromatase, an enzyme that makes estrogen from another hormone called androgen, to a more aggressive and lethal form of the cancer. Release

A drug-- 2ME2--that has shown promise in treating sarcoma, lung and brain cancers, demonstrates that the drug may also be effective in treating breast cancer, in particular the spread of breast cancer. Urszula Iwaniec, an assistant professor in the Department of Nutrition and Exercise Sciences at OSU, is the one of the authors of the study. Release

Genetics

The genome of the Abyssinian cat has been decoded, which will help advance research on some 200 human illnesses. Report

Shared genome data has been used to confirm that the SORL1 gene is linked to Alzheimer's. Report

UK scientists have discovered a genetic marker that may increase a person's susceptibility to rheumatoid arthritis. That work may highlight new targets for RA. Report

Genes linked to fruit fly sensitivity to alcohol may shed light on human drinking behavior. Report

New research published in the journal Nature revealed more than 50 genomic regions that are frequently gained or lost in lung adenocarcinoma, the most common type of lung cancer in the United States. Release

More Research

Scientists have discovered that the tuberculosis drug D-cycloserine can alleviate anxiety and counter fear when used in a combination therapy. Report

Researchers at the Saint Louis University School of Medicine have discovered the key brain chemical that causes Parkinson's disease--a "breakthrough" finding that could pave the way for new, far more effective therapies. Release

The unexplained pain experienced by patients with fibromyalgia is the result of a mismatch between sensory and motor systems, new research suggests. Release

British scientists say the nAG protein plays a critical role in spurring limb regeneration in newts, a discovery that could help advance the field of tissue regeneration. Report

A cold sore virus appears to be linked to Alzheimer's disease, a finding that could assist researchers looking for a vaccine to counter the threat. Report

Alzheimer's disease may progress more rapidly in people with high blood pressure or a form of irregular heartbeat, atrial fibrillation, according to results of a Johns Hopkins study published in Neurology. Release

Duke University Medical Center researchers have used imaging technology to identify a new marker that may help identify those at greatest risk for cognitive decline and the development of Alzheimer's disease. Release

Northwestern University researchers have shown that nanodiamonds are very effective at delivering chemotherapy drugs to cells without the negative effects associated with current drug delivery agents. Release

Influenza vaccine produced from animal cells

Mon, 16 Apr 2007 20:01:39 -0400

A scientific team at Taiwan's Vaccine Research and Development Centre spent 13 months and $1.2 million to develop a new, cell-based vaccine to target avian flu. One of the scientists said this was the first time that researchers used dog kidney cells in vaccine work. Baxter Vaccines, for example, has used green monkey kidney cells in its cell-based vaccine work. The researchers in Taiwan are building a pilot vaccine plant that will be ready by the end of the year and human clinical trials are scheduled for next year.

- check out the China Post report

ALSO: Scientists at the University of Rochester explain in a study published by the Journal of the American Medical Association how they produced an influenza vaccine in insect cells that appeared safe and effective. Recombinant DNA vaccines are already used on hepatitis B and HPV and researchers are looking to extend that to the flu and HIV. The new process would do away with the long and laborious process of using eggs to produce flu vaccine. Report

Related Articles:
The challenges of infectious disease. Report
WHO study points to threats of avian flu. Report

Growing heart valves from stem cells

Mon, 02 Apr 2007 20:01:39 -0400

Scientists in the U.K. have used stem cells harvested from bone marrow to create heart valve tissue. And they're pushing their work into animal studies this year in the hope that human clinical trials on valve transplants can begin in three years. The researchers grew the three-centimeter wide valves by exposing stem cells to chemicals, which spurred their differentiation into heart valve cells. The tissue was grown on a scaffold of collagen.

The research offers an organic alternative to the artificial heart valves that are currently used. Ultimately, the work could help point the way to creating entirely new hearts. The researchers at Imperial College London say that an organic valve is capable of changing to fit the physical needs of the patient. A valve created from stem cells would also be less likely to be rejected by the patient. Their report on the research will be published in the Philosophical Transactions of the Royal Society.

- read the CBC report on the stem cell work
- and here's the report from New Scientist

ALSO: Researchers at the University of Michigan Medical School write in the new issue of the journal Regenerative Medicine that we're drawing steadily closer to "bioengineering" entire areas of the heart, as well as heart valves and major blood vessels. Release

Related Articles:
Scientists grow new heart valves from stem cells. Report
New study to use stem cells after heart attacks. Report
Osiris reports major gains in stem cell trial. Report

Team coaxes stem cells to produce insulin

Wed, 25 Oct 2006 20:01:39 -0400

Researchers at San Diego-based Novocell have been able to turn embryonic stem cells into pancreatic cells capable of producing insulin. Their work points the way to repairing the destruction of cells that create insulin, a condition that causes type 1 diabetes. Observers of the work say they were particularly struck by the efficiency of the conversion of embryonic stem cells into pancreatic cells. Novocell Chief Scientific Officer Emmanuel Baetge told The New York Times that his team took the embryonic stem cells and manipulated them with growth factors in a way that mimicked the way the body produces pancreatic cells. That process takes up to three weeks. Novocell says it hopes to launch animal studies on the process in 2008 and begin human clinical trials a year after that.

- read the article from The New York Times
- see this report

Related Article:
Researchers at the University of Rochester and Cornell used stem cells to successfully cure Parkinson's in mice. However, 10 weeks into the study it was discovered that every one of the treated mice developed benign brain tumors. Report