January 22, 2021

The Niche

Trusted stem cell blog & resources

Michael Werner

3 min read

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much discussion today. The bill is called Cures for short and you can read the latest draft here. Cures may get a vote in Congress as early as tomorrow so this is …Read More

3 min read

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for that, especially from stem cell clinics. For instance, I am publicly opposed to the REGROW Act, a piece of legislation that would dangerously weaken oversight of experimental stem cell therapies. …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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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

1 min read

One of the best stem cell meetings each year is the World Alliance Form San Francisco (WAFSF) stem cell conference. It brings together in San Francisco many of the very best stem cell researchers from around the world doing the most cutting edge translational research. You should go! The speakers include Shinya Yamanaka, Masayo Takahashi, Michael Werner, Roman Reed, Susan Solomon, Jonathan Thomas, Edward Lanphier, Emile Nuwaysir, Hiromitsu Nakauchi, and many more top scientists. You can see the amazing program here and register here. …Read More

1 min read

If there was one stem cell meeting I would absolutely not want to miss next month in November if at all possible, it is the 2013 World Alliance Forum “Future of Stem Cells” in San Francisco. Are you going? Win free tickets to this meeting here! Unfortunately I have a conflict so I will this meeting, but perhaps you won’t have to! What’s this meeting all about? It has a remarkable array of speakers from diverse areas of the stem cell field including Shinya …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