How does one keep up with all the regenerative medicine and stem cell happenings? There is always something happening in the stem cell and regenerative medicine field ranging from science to policy matters. This post is an update on some recent stem cell happenings that I see as notable or interesting. New Pubs Direct reprogramming pub. One of the more interesting recent papers was from direct reprogramming guru Marius Wernig as his team came out with a new transdifferentiation paper that strikingly reports conversion …Read More
Alliance for Regenerative Medicine
The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of the clinics. This is the reality no matter what some of the patient advocates who promote the clinics might say. Such finalized FDA regs that unambiguously state that, for …Read More
By Student Society for Stem Cell Research at Berkeley UC Berkeley’s Student Society for Stem Cell Research (SSSCR) is proud to present its 3rd Annual Stem Cell Conference: “Culturing a Stem Cell Community” on Saturday October 17th from 9AM-5PM at the Li Ka Shing Center on the Berkeley Campus. This single-day Bay Area event is open to the public and geared towards all interested in the latest advances in stem cell research and regenerative medicine, including professionals, students, general public, and patient advocates. The …Read More
One of the hottest topics in the biomedical world in 2015 is heritable human genetic modification. There is an unsettling sense that genetically modified human germ cells and eventually GMO human beings are likely coming even if science and society are not ready for it. There are a hodgepodge of laws against human germline genetic modification, but it’s not clear that these regulations can realistically stop it from happening everywhere and they often do not apply to making GMO human germ cells. In a commentary piece …Read More
In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has requested that the FDA clarify the term “main function” for human cell and tissue products (HCT/Ps). ARM rightly points out that HCT/Ps can have more than one function. For example, adipose …Read More
Change is in the air for the California stem cell agency, CIRM. It has a new President, Randy Mills, and CIRM is soon going to be like a new agency too. I recently did an interview with Mills that illuminates some of the big changes that are imminent. I also asked him what his favorite type of stem cell is and his view of the regenerative medicine regulatory changes in Japan relative to those here with the FDA. Paul: Going from the biotech industry …Read More