The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers …
Translating the FDA’s Q&A on end of stem cell grace period Read More »
I wrote last week about the Nebraska and Iowa state Attorney Generals filing lawsuits against stem cell clinic firms and three individuals also named as defendants. Although I went into detail about the individuals including leader Travis Autor and the firms, I didn’t yet go into much depth on the state lawsuits themselves in that …
Q&A with Roxland on stem cell clinic suits by Iowa & Nebraska Read More »
Organoid based clinical trials are still rare and a Clinicaltrials.gov search for such organoid work largely brings up in vitro studies. A new clinical study in Japan where organoid material will actually be transplanted into patients is causing a lot of excitement. Organoid clinical trial Masayo Takahashi (高橋 政代) is a pioneer in stem cell-based …
Groundbreaking Organoid Vision Clinical Study: Takahashi Q&A Read More »
I’m continuing my stem cell patient Q&A series and today’s Q&A#2 post is focused on whether autoimmune patients generally or specifically those who have received chemo and hematopoietic stem cell transplants (HSCT) are at higher risk from COVID-19? Multiple patients have asked me this. It’s a great question and obviously urgent right now during the …
People ask me questions about stem cells all the time so I decide to do a new blog series answering your questions. Today’s post is the first in this new stem cell Q&A series. Past series have included my Elephant in the Lab series that provides some insights into the craziness that sometimes goes on …
Patients stem cell Q&A#1: can clinic injections cause GVHD? Read More »
ViaCyte is one of the most exciting stem cell and regenerative medicine biotech companies so I like to try to check in with them regularly. Today’s post is my new interview with ViaCyte leader Paul Laikind on recent developments. We had a great chat about the science and how things are looking upbeat for the …
ViaCyte Q&A: CRISPR Tx quick progress, ongoing diabetes trial, & more Read More »
A new right-to-try company called Beacon of Hope is stirring some intense discussion. State and federal right-to-try laws could potentially change the fabric of how many investigational studies are conducted. That may happen through firms like Beacon of Hope. However, we don’t know much about the firm. I’m hoping to help change that. Today’s post …
Richard Garr Q&A on his new Right-To-Try firm Beacon of Hope Read More »
We heard this week about the encouraging news of a new CRISPR-stem cell collaboration between stem cell biotech ViaCyte and CRISPR Therapeutics. The goal of the team is to make genetically engineered pancreatic derivatives from stem cells that would have a unique immune stealthiness. If such an approach was successful, patients would not need to …
Quick Q&A with ViaCyte CEO on CRISPR-stem cell work Read More »
At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it …
Helpful Zettler insights from Q&A on FDA suits against stem cell clinics Read More »
This is the second in a series of videos I’m doing where I answer questions about the stem cell field. You can see the Episode 1 video here. Today I tackle more questions on the stem cell field. If you have more stem cell questions, let me know and I’ll try to answer them next time. …
Q&A video with Paul Episode 2: stem cell & CRISPR questions answered Read More »