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Palo Alto, California-based StemCells said that the U.S. Patent and Trademark Office has issued a patent with broad claims covering human neural stem cells derived from any tissue source, including embryonic, fetal, juvenile, or adult tissue. The patent is exclusively licensed to StemCells. The company said it believes any third party wishing to commercialize neural stem cells as potential therapeutics or to use them as drug screening tools will have to seek a license from the company irrespective of how they derive the cells. The company has already granted licenses to several companies and is currently considering licensing others.

 

Medicare beneficiaries have limited knowledge of their Medicare Part D outpatient prescription drug benefits, and those who are unaware of the coverage gap are less likely to report cost-coping behaviors and more likely to report that the costs of drugs created a substantial financial burden, according to researchers. According to the study, published in the Journal of the American Medical Association, many seniors have trouble understanding these benefits, and that this poor knowledge limits their ability to manage their medication needs and costs. Seniors with worse knowledge were less likely to switch to less expensive medications, and more likely to report going without basic necessities, the researchers said. The study, by investigators with Kaiser Permanente’s Center for Health Policy Studies and the Division of Research; University of California, San Francisco; and Harvard University, interviewed 1,040 Medicare Advantage Prescription Drug plan beneficiaries who had a gap in their drug coverage if they exceeded $2,250 in drug costs. In the coverage gap, also called the “doughnut hole,” these beneficiaries had to pay for the full cost of their outpatient medications.

PRE-PREGNANCY DIABETES: STUDY FINDS RATE DOUBLED IN JUST SIX YEARS
Diabetes before motherhood more than doubled in six years among teenage and adult women, according to a Kaiser Permanente study published in the journal Diabetes Care. The study is the largest and most diverse study to examine pre-pregnancy type 1 and type 2 diabetes. Researchers at Kaiser Permanente’s Department of Research & Evaluation in Pasadena looked at 175,249 women who gave birth in 11 Kaiser Permanente hospitals in Southern California between 1999 and 2005. Researchers found that there were twice as many births to women with diabetes in 2005 as there were in 1999. Fifty-two percent of the women in the study were Hispanic, 26 percent were White, 11 percent were Asian/Pacific Islanders, and 10 percent were African-American. This study found significant jumps in pre-pregnancy diabetes in every age, racial, and ethnic group. Among the most dramatic findings the researchers reported a five-fold increased in diabetes among 13- to 19-year-olds giving birth. The researchers said limiting obesity is the best way to reduce the rising incidence of type 2 diabetes in young women.

NEUROLOGY: VITAMIN D PLAYS AN IMPORTANT ROLE IN BRAIN DEVELOPMENT AND FUNCTION
In a critical review, scientists at Children’s Hospital & Research Center Oakland found there is convincing evidence linking vitamin D deficiency to brain dysfunction. The researchers said that supplementation for groups chronically low in vitamin D is warranted. Their conclusions, published in the Federation of American Societies for Experimental Biology Journal, showed that while vitamin D has an important role in the development and function of the brain, its exact effects on behavior remain unclear. Vitamin D has long been known to promote healthy bones by regulating calcium levels in the body. Lack of sufficient vitamin D in very young children results in rickets, which can be easily prevented by vitamin D supplements. Only recently the scientific community has become aware of a much broader role for vitamin D.

 

MEDICARE PART D: SICKEST PATIENTS STILL SKIPPING MEDS BECAUSE OF COST
The Medicare Part D drug benefit have made it less likely for beneficiaries to cut back on basic necessities in order to pay for medicine, but researchers at Harvard Medical School and Harvard Pilgrim Health Care find the sickest patients are still skipping medications for financial reasons. The study, published in the Journal of the American Medical Association, found encouraging signs of relief, but the researchers said the problem of unmanageable drug costs has by no means been eliminated. The study found that the rate of skipping pills and prescriptions due to cost declined from 14.1 percent of beneficiaries in 2005 to 11.5 percent in 2006. Spending less on basic needs to afford medicine declined from 11.1 percent to 7.6 percent over the same period. But the sickest patients, who skipped pills at about twice the rate of healthier patients in 2004 and 2005, experienced no improvements in pill-skipping after Part D began in 2006, even though they were less likely to cut back on basic necessities to pay for medicine after Part D.

REGENERATIVE MEDICINE: VISTAGEN COLLABORATES WITH RESEARCHERS TO ISOLATE EARLIEST ESC-DERIVED CARDIAC CELLS
South San Francisco, California-based VistaGen Therapeutics, along with a team of Canadian, American, and British researchers, have used embryonic stem cell differentiation cultures to identify, grow, and study the earliest cell destined to form the human heart. This novel cardiac stem cell is able to produce all three types of cells important to the cardiovascular system. The research, published in the journal Nature, represents another step towards generating and validating functional human heart cells at a scale and purity that is necessary for pharmaceutical discovery applications and for predictive toxicity screening of new drug candidates, the company said.

NEUROPROTECTION: INFLAMMATION TRIGGERS CELL FUSION THAT COULD PROTECT NEURONS
Chronic inflammation triggers bone marrow-derived blood cells to travel to the brain and fuse with a certain type of neuron up to 100 times more frequently than previously believed, according to researchers at Stanford University School of Medicine. After the fusion, the blood-cell nuclei begin to express previously silent, neuron-specific genes. The surprise finding in mice, published online in Nature Cell Biology, suggests that the creation of the fused cells, called heterokaryons, may possibly play a role in protecting neurons against damage and may open new doors to cell-mediated gene therapy. The bone marrow-derived cells are known as blood stem cells, or hematopoietic stem cells. They can give rise to all the blood and immune cells in the body. Although the progeny of these hematopoietic stem cells have previously been shown to fuse with a variety of other cell types in the body, this fusion occurs so infrequently that it had been thought to have little biological significance.

 

BLOOD SUPPLY SAFETY: CERUS GETS EXPANDED LABEL CLAIM FOR ITS BLOOD CLEANING SYSTEM
Concord, California-based Cerus said that European regulators have granted the company expanded label claims for use of platelets and plasma treated with the Intercept Blood System to prevent transfusion-associated graft-vs.-host disease in at-risk patients. While transfusion-associated graft-vs.-host disease is a rare disorder, prevention is critical because it is a condition with greater than 80 percent mortality and no treatment options. These expanded label claims allow blood banks in Europe to use the Intercept Blood System in place of gamma irradiation for the prevention of transfusion-associated graft-vs.-host. Intercept is the only CE-marked alternative to gamma irradiation. Transfusion-associated graft-vs.-host disease is a rare but usually fatal complication of transfusion in patients who have undergone bone marrow transplant, are immune-compromised, or have a high similarity between donor and recipient HLA haplotypes. In these patients, donor T lymphocytes mount an inflammatory immune response against the recipient's lymphoid tissue following blood transfusion, resulting in a mortality rate of 80 to 90 percent.