August 12, 2020

The Niche

Knoepfler lab stem cell blog

Alliance for Regenerative Medicine

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 The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation.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