January 16, 2021

The Niche

Trusted stem cell blog & resources

Month: November 2016

4 min read

The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field.  What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the stem cell provisions in Cures. What would it mean? Cures’ language on stem cells is nuanced and its provisions also are not so black and white as REGROW was in …Read More

3 min read

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much discussion today. The bill is called Cures for short and you can read the latest draft here. Cures may get a vote in Congress as early as tomorrow so this is …Read More

6 min read

Concerns over stem cell clinics allegedly causing blindness or other vision problems have been increasing in 2016. If this is in fact happening, the extra sad part of this is that some clinics have claimed that they are doing the opposite: improving vision in patients. What are the concerns? Earlier this year a publicly-traded stem cell business in Florida called U.S. Stem Cell, Inc. was sued along with other defendants by a former customer Elizabeth Noble, alleging harm done via an experimental stem cell “treatment” …Read More

1 min read

Rainbow stem cell clones. From Scientific Reports: NF-kappaΒ-inducing kinase regulates stem cell phenotype in breast cancer. A call for stem cell optimism. How to harvest stem cells from teeth Stem Cell Transplant Startup With Harvard Tech, Magenta Therapeutics, Gets $48.5M Neurogenic Radial Glia-like Cells in Meninges Migrate and Differentiate into Functionally Integrated Neurons in the Neonatal Cortex (from Cell Stem Cell). Researchers Grow Functioning Human Intestines, Nerves Using Stem Cells Stem cell treatments for some kinds of deafness within a decade?

2 min read

It takes a great deal of courage to participate in a clinical trial, patients who make that choice are heroes in my book and one such hero with stem cells was Ted Harada who had ALS. Sadly, Ted passed away from a brain tumor called glioblastoma last month. When enrolling in a trial, you just never know if it will be beneficial or even be safe, and this is especially true of early phase clinical trials. As a result, it takes guts to be a …Read More

3 min read

I’m hearing more questions from the community about alleged harm from stem cell clinics selling stem cells for a number of vision-related conditions and some concerns include the so-called SCOTS study. I first blogged about SCOTS early this year and back then I myself had questions too. Some commenters then raised concerns or questions about SCOTS in weighing in on that post. In my opinion SCOTS is almost certainly not a traditional FDA phased clinical trial, which raises issues right from the get go. I’m not aware …Read More

1 min read

Will Trump trump the FDA? Our President-elect recently released his health care policy agenda and it looks like the FDA is a target in terms of reducing oversight. Over at the Washington Post, Carolyn Johnson has a nice article on this development. One point in the agenda in particular has caught people’s attention as potentially the key indicator of what is to come for regulatory oversight of biomedical products: “Reform the Food and Drug Administration, to put greater focus on the need of patients for new …Read More

2 min read

I appreciate fun linguistic approaches to explaining science such as a good science metaphor and I use them myself at times, but sometimes these end up risking doing much more harm than good. The best or should I say worst example I’ve heard recently is referring to a growth factor called BDNF as “Miracle-Gro for the brain”. What the heck? BDNF is the acronym for brain-derived neurotrophic factor. It is a growth and trophic factor that has the exciting potential to induce helpful changes in the …Read More

1 min read

I’m organizing my own thinking on how Trump’s election will impact science and stem cell/regenerative medicine research in particular and will post on that soon, but for now here are some of the early responses I’ve seen where scientists comment on this big, unexpected event and key questions. These are in addition to the almost infinite number of expressions of angst on Twitter. At Nature, “What scientists should focus on — and fear — under Trump” Jeremy Berg, Editor of Science, on Reunifying America …Read More

2 min read

The FDA caused major controversy by approving the drug Exondys 51 from Sarepta Therapeutics for treating Duchenne muscular dystrophy over the recommendations of a scientific panel it convened that had voted 7-3 against approval. Is this contentious Sarepta approval serve as a sign of how the FDA will deal with stem cells moving forward? Will the FDA approval, which was based on very limited, unclear data and in large part due to pressure from some patient advocates, serve as a warning to those of us hoping the agency …Read More