I’ve been concerned about a stem cell group called MD Stem Cells for many years. Now it comes under more scrutiny from a new must-read piece by Donna Young over at S&P Global. Young’s article reports a puzzling, purported right-to-try (RTT) program that MD Stem Cells appears to working on with Richard Garr. Note that …
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 »
Every so often I realize I’ve accumulated a bunch of tabs on my browsers of things I need to dive into as time permits, which sometimes translates into a collection of recommended reads here on The Niche. Here are some recommended recent reads in the stem cell/regenerative medicine field and childhood cancer space. It includes …
Weekend reads: stem cells, CRISPR, glioma, stroke, RTT & more Read More »
A new Florida bill (Bill 65 of 2019) could make the practices of stem cell clinics a felony. At the same time it would open the door to patients receiving still experimental stem cells that have at least started the clinical trial process. What’s going on? A number of states have been stepping up action …
New Florida bill mixes RTT spirit with turning unproven stem cell sales into a felony Read More »
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. RMATs RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with …
Stem cell news July 2018: RMATs, RTT, MiMedx mess, clinic family ties & more Read More »
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 …
Stem cell & regenerative medicine news: cool pubs, people, ARM, & more Read More »
The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally …
10 questions on FDA suits targeting stem cell clinics Read More »
The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted …
What happens if we mix stem cells with populism? From a populist view of stem cells, everyday patients should be able to do nearly anything they want with stem cells without any governmental interference or excessive expense. Even stem cells not proven to be safe or effective. This can sound like an appealing idea to …
The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia. The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more …
Australia takes big step to curtail dangerous stem cell clinics Read More »