There appears to be a big, risky loophole in the relatively new national Right To Try law. Some folks apparently anticipated this problem long ago, but I think most of us weren’t aware of it. Update: More specifically, some law and policy experts were writing about this and other potential loopholes in 2018. I recommend […]
Right To Try law has a big loophole that’s an opening for bad actors Read More »
When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years
What is stromal vascular fraction or SVF? Read More »
If a picture is worth a thousand words, how about a Facebook video from a stem cell clinic? In my view it sure tells a story with some unusual twists. I wrote last week about this Facebook video by Kristin Comella, the leader of the publicly-traded stem cell clinic firm US Stem Cell, Inc. (USRM). As
Up your nose? OMG Facebook video moments from clinic sued by DOJ Read More »
Two physicians are central to something called the SCOTS trial, Dr. Jeffrey Weiss and Steven Levy. Patients have claimed negative outcomes after participating in the trial. What’s going on here? SCOTS trial The recent NEJM paper reporting on the blinding of three patients in Florida may be just the beginning. More information has come out on negative
Dr. Jeffrey Weiss, SCOTS trial, & Patient Claims of Blindness Read More »
What were the top posts here on The Niche for the past year? I’ve listed some of them below along with some posts from 2015 that remain highly read. Some top 2016 posts 20 Nominees for Stem Cell Person of the Year 2016 Award REGROW Act is Attack on Science-Based Stem Cell Trial Oversight Will new
The Niche top posts of 2016 Read More »
Today an opinion piece that I wrote about CIRM was published in the San Francisco Chronicle. The unusual element here is that the article is critical of CIRM. More specifically I raised concerns about a recent political trend at CIRM under its new President Randy Mills lobbying for dramatically weaker stem cell regulatory oversight. The Chronicle piece was first posted
The backstory on my opinion piece in SF Chronicle critical of CIRM lobbying Read More »
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
Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited Read More »
Stem cell biotech company Bioheart ($BHRT) has had a rough 2015 so far. Could this year be a decisive, negative tipping point for the company? It has a number of clinical trials going, but from my view things seem increasingly uncertain. An oddity amongst stem cell biotechs, Bioheart and its leadership have at times seemed to toy
Bioheart on the edge in 2015? Read More »
I invited the Chief Scientific Officer (CSO) of Bioheart, Kristin Comella, to do an interview after hearing some buzz that this could be a critical time for the company and that it might have been recently visited by the FDA. Note that Comella not just Bioheart CSO, but also the primary instructor for physician training in stem
Interview with Bioheart CSO, Kristin Comella including on FDA Read More »
It’s hard to even imagine the world of investigative medicine without the wonderful resource of Clinicaltrials.gov, the global hub for clinical trial listings. I recently interviewed the Director of Clinicaltrials.gov, Dr. Deborah Zarin here, which is a fascinating read. As great as Clinicaltrials.gov is as a resource, unfortunately it faces a new, rapidly growing problem that is a serious
Clinicaltrials.gov Mission At Risk From Proliferating For-Profit Trials Read More »