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Researchers aim to bring new technologies and treatments from the bench to the bedside

Boston University : 09 June, 2006  (Technical Article)
A non-invasive test to predict a smoker
“The reason the Ignition Awards program exists is to recognize research that will someday translate into commercially available technologies, products, or treatments,” said Stanford Willie, Ph.D., executive director of the Office of Technology Development at BU. “The first batch of winning projects represent diverse and potentially life-saving applications in health and medicine and were recognized for their strong commercial potential.”

Does the Nose Know? Testing Nasal Cells for Lung Cancer Risk
Profiles of gene expression in humans have been increasingly used for diagnosing a variety of diseases, determining an individual patient’s prognosis, and for developing new therapies. Most studies of gene expression have involved surgically sampling diseased tissue which limits the potential for using these methods in large numbers of patients.

Jerome Brody, M.D., a professor at the BU School of Medicine and director of the school’s Pulmonary Center, Avrum Spira, M.D., an assistant professor of medicine, and their team have shown that gene expression patterns of airway epithelial cells, the surface cells that line the entire respiratory tract, taken during bronchscopy can be used to diagnose lung cancer. All epithelial cells, from the nose to the lung, are exposed to inhalants like cigarette smoke, ozone, and allergens.

“Previous analysis of these cells has shown that many genes that work to detoxify the harmful components of cigarette smoke and protect the lung from injury are increased in smokers, as are several tumor inducing genes, while tumor suppressing genes are decreased, even in smokers without lung cancer,” said Dr. Brody. “We have shown that by analyzing gene expression in these cells, we can derive the profile of genes that establish the diagnosis of lung cancer.”

Although bronchscopy is less invasive than a biopsy of lung tissue, it must be done in a hospital and cannot be used as a broad population survey tool. The researchers are now exploring if gene expression in epithelial cells obtained by gently brushing the inside of the nose can show how an individual has responded to toxic inhalants and whether these cells can be used to provide insight into what is happening in the lung.

Preliminary results show that many of the genes altered by smoking in the cells obtained through bronchoscopy are also changed in the cells from the nose. In addition, the gene expression profile of nasal cells from patients with pulmonary sarcoidosis, a disease thought to be caused by inhalants that can lower the amount of air the lungs can hold, are altered in a distinct pattern which may serve as a valuable diagnostic tool for this condition.

“The Ignition Award we have received from the Office of Technology Development provides the funds to develop the nasal gene expression test as a new, non-invasive tool for diagnosing pulmonary sarcoidosis, and will allow us to begin exploring the potential of the nose knowing whether a current or former smoker has or is at risk for developing lung cancer,” said Dr. Brody.

Insulin Factories: Programming Stem Cells to Release Therapeutic Hormones
Therapeutic peptide hormones, such as insulin, human growth hormone, and interferon, are traditionally administered by patient self-injection, but the discomfort and anxiety caused by needles often leads to low patient compliance and thus decreased treatment outcomes.

BU School of Medicine Professor M. Michael Wolfe, M.D. and his team are working on a new technology that may one day replace the way therapeutic peptide hormones are manufactured and delivered. The researchers are investigating the use of engineered stem cells that are implanted into the lining of the small intestine and are programmed to manufacture and release these therapies into the blood, eliminating the need for repeat injections.

According to Dr. Wolfe, the stem cells may be derived from a patient’s own bone marrow or fat tissue and can be grown for an indefinite period of time in a laboratory.

“After enough cells expressing the therapeutic peptide have been prepared, the plan is to use minimally invasive endoscopic techniques to implant them,” said Dr. Wolfe. “Once re-implanted into the patient, the cells appear to assume many of the characteristics of neighboring cells of the small intestinal lining in which they now reside.”

Dr. Wolfe says these engineered stem cells may be likened to miniature “factories” that manufacture and deliver specific peptide-based medicines. However, they differ from current treatments that employ stem cells in two important ways: since the cells are not from embryos, but rather derived from individual patients themselves, immune system rejection is impossible; and, the cells are being programmed to perform a specific task rather than being implanted with no direction.

“These differences offer significant advantages over technologies currently in development,” said Dr. Wolfe. “The Ignition Award will help us further develop this novel approach which epitomizes “concierge” medicine, an individualized approach to treating patients for the new millennium.”

Pain Relief without the Risk of Addiction
Helping patients manage chronic pain is a significant challenge for doctors. In the U.S. alone, 8 million people have cancer or have been treated for cancer in the past. Approximately 10 percent of these patients will encounter bouts with pain that are difficult to manage with conventional treatments. Additionally, people with AIDS, post-operative surgical patients, individuals with diabetic nerve damage, post herpetic neuralgia, a painful condition that affects nerve fibers and the skin, and fibromyalgia encounter severe pain on a regular basis.

This substantial need for new, non-addictive painkillers led David Farb, Ph.D., a pharmacology professor at the BU School of Medicine, and his team to investigate the use of pregnanolone hemisuccinate, a non-opioid compound derived from the natural products pregnanolone, a chemical present in the urine of pregnant women, and succinic acid, which is found in amber.

According to Dr. Farb, in preclinical animal studies, PAHS demonstrated both anesthetic and analgesic (painkilling) activity, comparable in efficacy to morphine. Sedation and general anesthesia were observed when the drug was given intravenously at higher doses. This is unique since non-sedating doses of anesthetics do not typically relieve pain.

“The objective of this Ignition Award is to determine the specific mechanism of action by which this novel compound can cause both anesthesia and pain relief,” said Dr. Farb.

“Our research thus far shows there is potential for PAHS to be used as an intravenous or injectable drug for both pain management and anesthesia,” said Dr. Farb. “We also hope to develop an oral formulation of the drug in the future. Since it is non-habit-forming, the potential impact is broad for the millions of people who suffer from acute chronic pain.”

In addition, based on studies from Dr. Farb’s laboratory, PAHS inhibits the reinstatement of cocaine self-administration and has been selected for study by the NIH Addiction Treatment Discovery Program as a potential new medication for the treatment of cocaine abuse.
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