September 25, 2020

The Niche

Knoepfler lab stem cell blog

ARM

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

3 min read

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

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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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

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