Post-publication (post-pub) review is arguably one of the most innovative developments in scientific publishing in the past few years, including at the site PubPeer. An illustration of the widespread influence of post-pub review is the fact that PubMed recently started allowing readers to post comments about any paper. Post-pub review drove the rapid debunking of the […]
Will Lawsuit Against PubPeer Chill Post-Pub Review? Read More »
StemCells, Inc. is one of those stem cell-related biotech companies that we in the field hope will become a big success and help many patients in the future via stem cell technology. There are a lot of obstacles facing such companies. Some are privately held, while others such as StemCells, Inc. are publicly traded (stock
StemCells, Inc. Faces Lawsuit With Serious Allegations Read More »
ABC News just reported that the FDA is allgedly “cracking down” on the publicly traded company, MiMedx (MDXG), which sells a placental derivative touted for healing powers. The Wall Street Journal is also following the story. According to ABC News: MiMedx is a publically traded, for-profit company that takes donated human placentas — solicited via a website featuring
MiMedx (MDXG) placental “stem cell magnet” drugs attract FDA attention and lawsuit Read More »
I’ve asked Celltex a few questions about the lawsuits between it and RNL Bio/Biostar. I appreciate their willingness to engage on this. Note, I’m also hoping to obtain contact information for RNL Bio/Biostar to ask them some questions too. Below are my questions and the Celltex answers, hopefully part 1 of 2 parts with the 2nd
Q & A with Celltex on lawsuits between it and RNL Bio/Biostar: part 1 Read More »
Dr. James Sherley, the scientist behind the lawsuit against federally-funded ES cell research, has penned an opinion piece in The Daily Caller today calling on NIH to, in his words, ‘do the right thing.’ However, what Sherley is really asking is for the NIH, other stem cell scientists, and all Americans to think like he
James Sherley of anti-ESC lawsuit calls on NIH to think like he does Read More »
What is a stem cell therapy? Does it have to include stem cells put into the body? Would you include a therapy that uses differentiated cells made from stem cells? I generally do use the term in that broader way. A similar question comes to mind: what is regenerative medicine? Should it include both cell
Weekly stem cell reads: HSCT, old embryo models, aging stem cells Read More »
QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a class action lawsuit. They report having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands of customers.
QC Kinetix review: concerns on huge regenerative clinic chain Read More »
The FDA recently warned Frontier Biologics, LLC, a Texas perinatal tissue manufacturer firm. Tallying the many FDA biologics warnings in 2024 It can sometimes feel like there are an uncountable number of unproven stem cell clinics However, the good news is that the FDA has been doing much more on this front in 2024. With
FDA warns Frontier Biologics as part of its more active trend Read More »
What happens if unproven stem cell clinic firms like GIOSTAR start getting okays from the FDA to do clinical trials? On the one hand, it could reflect a positive trend of stem cell clinic firms working with the FDA and toward compliance. Having more robust data. However, I worry about some of these types of
It’s been a long saga for the FDA and the unproven stem cell clinic group called Cell Surgical Network, headquartered in Beverly Hills. A court case involving the two has been unfolding for many years. It has big implications for agency authority and the hundreds of stem cell clinics across the U.S. The case took