January 27, 2021

The Niche

Trusted stem cell blog & resources

Alliance for Regenerative Medicine

2 min read

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

5 min read

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

2 min read

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

3 min read

One of the hottest topics in the biomedical world in 2015 is heritable human genetic modification including via germ cells. 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. …Read More

1 min read

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

9 min read

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

1 min read

By Mansee Desai UC Berkeley’s Student Society for Stem Cell Research (SSSCR) is proud to present its 2nd Annual Stem Cell Conference: “Culturing a Stem Cell Community” on Saturday October 4th from 10AM-5PM at the university’s Li Ka Shing Center. Building upon the success of last year’s conference, this year’s event features an internationally renowned line-up of speakers, a “Meet the Experts” luncheon, and a poster session. We have some great speakers including Judith Campisi, Arnold Kriegstein, David Schaffer, Irina Conboy, Danica Chen, Allan …Read More

2 min read

I just heard some very good news on the regenerative medicine front. US Senators Barbara Boxer and Mark Kirk today introduced The Regenerative Medicine Promotion Act, which would keep track of and promote regenerative medicine efforts. This is really exciting and provides hope. One of the neat things about this news is that Boxer is a California Democrat, while Kirk is an Illinois Republican so this is fantastic bipartisanship. On Boxer’s website there are some quotes that resonated strongly with me from the two …Read More

2 min read

The Board of Directors of the Coalition for the Advancement of Medical Research (CAMR) announced today that they have voted to dissolve the organization. CAMR is effectively at an end. The CAMR Board has decided, as described in an email, to “transfer its mission and its resources to an outstanding colleague organization, the Alliance for Regenerative Medicine (ARM).” The press release (PR) from CAMR does not clearly articulate a specific reason for dissolving itself. In the PR, CAMR president Amy Comstock Rick, J.D, is quoted as …Read More

11 min read

Today’s post is an interview I did with Dr. Van Bokkelen covering 10 questions. Dr. Gil Van Bokkelen is Chairman and CEO of Athersys, Inc., a company that has focused heavily on stem cells and regenerative medicine for more than a decade. For more on Dr. Van Bokkelen’s background see additional bio section at the end of this post. 1. Why stem cells? Of all the biotech areas you could have worked on, what inspired you to work on stem cells? Was there a defining moment, …Read More