Search Results for: rmat

Groundbreaking new California stem cell law gives consumer protections on clinics

Official_Headshot_Senator_Hernandez

California now has a first-of-its-kind stem cell law that requires clinics pitching non-FDA approved stem cell offerings to be upfront with patients. It’s a bill that will help to protect patients. How? With Jerry Brown’s signature yesterday, the new California law mandates that stem cell clinics in our state take some steps to inform patients

Groundbreaking new California stem cell law gives consumer protections on clinics Read More »

Why Mitalipov’s ‘magic’ room for human embryo CRISPR may give us pause

Shoukhrat-Mitalipov

The debate over whether the main conclusions of the Nature paper on human embryo CRISPR led by Shoukhrat Mitalipov’s lab at Oregon Health Sciences University (OHSU) are correct remains unresolved. Note that Nature just added an editorial alert just above the references section to their paper: “Updated online 02 October 2017. Editorial Note: Readers are alerted that some

Why Mitalipov’s ‘magic’ room for human embryo CRISPR may give us pause Read More »

New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network

Cell-Surgical-Network-Founders

Two new FDA inspection reports called 483s provide fresh insights on a stem cell clinic, the network of clinics that it belongs to, and adverse events in patients. These reports detail issues the FDA found at the stem cell clinic California Stem Cell Treatment Center and its parent chain of clinics, Cell Surgical Network. The

New FDA Inspection 483s: Insights on Stem Cell Clinic & Cell Surgical Network Read More »

Mitalipov briefly responds to Egli preprint, stands by human embryo CRISPR pub findings

Shoukhrat-Mitalipov

There has been a wave of intense discussions both in the public domain such as on Twitter and behind the scenes over the new Egli, et al. preprint that challenges the main conclusions of the Ma, et al. Nature paper from Shoukhrat Mitalipov’s lab. Ma, et al. reported CRISPR gene editing of human embryos, arguing for

Mitalipov briefly responds to Egli preprint, stands by human embryo CRISPR pub findings Read More »

Doubts raised on key points of Nature paper on CRISPR gene editing of human embryos

Egli-Mitalipov-preprint

Is it possible that CRISPR gene editing actually didn’t happen in many of the human embryos in that big Nature paper that made such news a couple weeks back? Some doubts have emerged that call the main conclusions of the paper into question and argue that more definitive studies are needed to be sure. An

Doubts raised on key points of Nature paper on CRISPR gene editing of human embryos Read More »

Will Right-To-Try Morph into Right-To-Profit for Stem Cell Clinics?

FDA-RMAT

On one level a reasonable argument can be made for letting terminally ill patients have a right to try experimental as yet unproven therapies, but in the real world Right-To-Try laws have many downsides. On the whole, they are likely to be negative for patients as a group.  Raising the stakes is a push for

Will Right-To-Try Morph into Right-To-Profit for Stem Cell Clinics? Read More »

Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte

VC-01-post-implant-final1-e1503703572933, viacyte

It’s a difficult, but very important road to conclusively prove that an investigational stem cell therapy is both safe and effective in order to get final approval FDA or equivalents in other countries. For this reason, it is beneficial to highlight even small, but positive steps forward including encouraging pre-clinical data. Today I’m doing a

Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte Read More »