September 30, 2020

The Niche

Knoepfler lab stem cell blog

MiMedx

2 min read

In the past month or two there has been a steady stream of good news in the stem cell and regenerative medicine world. Here are three examples. Fate Therapeutics announced the first US IND for an induced pluripotent stem cell (IPSC)-related product. Its cleared product, FT500, is an off-the-shelf natural killer-based cancer immunotherapy. I expect more to come in the next couple years so good news now and likely more to come. IPSC-based trials are picking up in Japan too with trials related to …Read More

3 min read

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative …Read More

3 min read

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its product acting like a “stem cell magnet.” More recently I did a 2nd post mentioning the company a few months back focusing on its contributions to former Sen. Mark Kirk, whose legislative baby the …Read More

4 min read

The money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients. Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to polls, has been the leading backer of the REGROW Act. Kirk has been more in the news of late due to extremely controversial Trump-like comments he made about his …Read More