Traditional clinical trials have four phases. Each phase plays an important, unique role in testing whether new drug products are safe and effective as well as how they compare to the standard of care. Today in the stem cell field across the globe, the Phase III is under fire including what some might call friendly …
Important, endangered species in stem cell medicine: the phase III trial Read More »
On Thursday here at UC Davis School of Medicine we held our second annual Stem Cell Ethics Symposium. The symposium was organized by Drs. Mark Yarborough and Nanette Joyce as well as me. In this post I report on key take homes from the meeting and summarize the specific talks. As far as I know, this is one of the few …
Meeting review of unique stem cell ethics symposium @UCDAVIS Read More »
It’s been a seemingly rather quiet year on the regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank the …
New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Research Read More »
Ted Harada is a wonderful patient advocate for the stem cell field and for the development of safe and effective stem cell products to treat ALS. Ted has ALS and received stem cell-based treatments for it with surprising, very encouraging results. The Harada family is pictured at left with Ted, his wife Michelle as well as …
Ted Harada Interview Part 1: Stem Cells for ALS, More Read More »
Is Neuralstem flirting with noncompliance via a Right To Try Law in Colorado? Colorado is an independent-minded state. For example, it is one of only a few states including Washington State with legalized marijuana use. More recently, Colorado passed a new law supported by the ultra-conservative Goldwater Institute, the so-called Right To Try Law. This law …
Neuralstem flirting with noncompliance via Right To Try Law? Read More »
We need medical innovations, but what is the appropriate way for agencies like the FDA to regulate the process and fight bogus interventions based solely on hype? Without innovation, medicine becomes stagnant and hope fades for patients who have any one of numerous conditions that are currently inadequately addressed by medicine. I can relate on …
What is the FDA’s appropriate role in regulating medical innovations such as stem cells? Read More »
Tonight, President Obama will give his “State of the Union” annual address on how our country is doing. I’m guessing he will say the state of the union is positive, but with challenges. What is the state of the union for stem cells in America today? Overall I think it’s extremely encouraging and the field …
The voting is over and we have our top 12 finalists for the 2013 Stem Cell Person of the Year Award. You can see the final votes results below. It’s definitely an intriguing list that reflects the range of important areas in the field today. I can say without any hesitation that all 12 of …
Dozen Finalists for Stem Cell Person of the Year 2013 Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through …
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation Read More »
Today’s post is an interview I did with Dr. Van Bokkelen covering 10 questions. Dr. Gil Van Bokkelen is Chairman and CEO of Athersys, Inc., a company that has focused heavily on stem cells and regenerative medicine for more than a decade. For more on Dr. Van Bokkelen’s background see additional bio section at the end of …