When personal genomics and biotech firm 23andMe was founded in Mountain View, Calif., in 2006, the hype over the genetic tests it offered directly to consumers was immediate and irresistible to many. The company promised that for a nominal fee, it could scan your saliva sample and tell you based on your genetics everything from who your ancestors were to what diseases you may be at risk of developing many years down the road. 23andMe raised more than $100 million in capital from such big-name investors as Google and Genentech. Today, the companys website boasts having close to 500,000 genotyped consumers. So it was a surprise to some observers when, on November 22, the U.S. Food & Drug Administration (FDA) sent a strongly worded letter to 23andMe CEO Anne Wojcicki demanding that the company stop marketing its test, called Personal Genome Service (PGS), until it secures authorization from the agency. The FDA contends that PGS is a medical device being pitched for the diagnosis and prevention of disease, and therefore it must obtain approval under federal law. Whenever regulators step in and try to yank a product off the market particularly when the company selling it is already well entrenched … Continue reading →

PUBLIC RELEASE DATE: 16-Dec-2013 Contact: Shaun Mason smason@mednet.ucla.edu 310-206-2805 University of California - Los Angeles Scientists from UCLA are now bringing their groundbreaking stem cell science directly to patients in two exciting new clinical trials scheduled to begin in early 2014, thanks to funding from California's stem cell agency. The new grants to researchers at UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, which total nearly $21 million, were announced Dec. 12 at a meeting of the California Institute of Regenerative Medicine (CIRM) Citizen's Oversight Committee. They are apart of the state agency's Disease Team Therapy Development III initiative. A team led by UCLA's Dr. Dennis Slamon and Dr. Zev Wainberg was awarded nearly $7 million for a clinical trial that will test a new drug targeting cancer stem cells, and UCLA's Dr. Donald Kohn received almost $14 million for a clinical trial that will focus on stem-cell gene therapy for sickle cell disease. "The CIRM support demonstrates that our multidisciplinary center is at the forefront of translating basic scientific research into new drug and cellular therapies that will revolutionize medicine," said Dr. Owen Witte, director of the UCLA Broad Stem Cell Research Center. Dennis … Continue reading →

Stem Cell Therapy: Helping the Body Heal Itself Stem cells are natures own transformers. When the body is injured, stem cells travel the scene of the accident. Some come from the bone marrow, a modest number of others, from the heart itself. Additionally, theyre not all the same. There, they may help heal damaged tissue. They do this by secreting local hormones to rescue damaged heart cells and occasionally turning into heart muscle cells themselves. Stem cells do a fairly good job. But they could do better for some reason, the heart stops signaling for heart cells after only a week or so after the damage has occurred, leaving the repair job mostly undone. The partially repaired tissue becomes a burden to the heart, forcing it to work harder and less efficiently, leading to heart failure. Initial research used a patients own stem cells, derived from the bone marrow, mainly because they were readily available and had worked in animal studies. Careful study revealed only a very modest benefit, so researchers have moved on to evaluate more promising approaches, including: No matter what you may read, stem cell therapy for damaged hearts has yet to be proven fully safe and … Continue reading →

SINGAPORE: A team of experts from Singapore's National University Hospital (NUH) has made a clinical breakthrough in their work on foetal stem cell treatment. The team is part of an international collaboration comprising researches from Karolinska Institutet, Sweden, and Taiwan. The treatment involves the injection of stem cells into a foetus while still in the mother's womb to treat various abnormalities and genetic disorders. The experts announced this after successfully treating two girls with brittle bone disease. One of them is a four year-old who was treated in Singapore. The team plans to carry out further research on the use of stem cell treatment for other prenatal abnormalities. Dr Citra Mattar, associate consultant from the Department of Obstetrics & Gynaecology at NUH, said: "Treating a foetus that's only 12 grams or 20 grams in the early part of pregnancy is likely to be much more effective when we give a certain dose of stem cell or gene therapy product; compared to treating a baby -- when it's born it's 2.5 kg, it's much bigger than the foetus. So we can use a smaller amount of product to achieve a greater result." Continued here: Foetal stem cell treatment sees success in … Continue reading →