January 17, 2021

The Niche

Trusted stem cell blog & resources

Michael Hiltzik

6 min read

The FDA and its CBER branch have been doing a good job overall in the last 3+ years to tackle the unproven stem cell clinic problem, but lately on the stem cells for COVID-19 front there is reason for real concern. I believe the agency is taking on major risk overall by clearing a vast number of cell therapy trials for COVID-19 mostly without much data, but the clearance of a few programs by for-profit stem cell clinics is especially problematic in my view. FDA on …Read More

7 min read

Stem cell clinics and suppliers have been getting into the business of making promotional films to generate more revenue, but now there’s something very different in the cinematic stem cell arena called From Jail Cell to Stem Cell by filmmaker Doug Orchard. It is at its heart an exposé film about some in my view particularly concerning stem cell and exosome clinics and suppliers. The only other thing similar to this was 2019’s great podcast Bad Batch. Reviewing the movie From Jail Cell to Stem Cell Today’s …Read More

4 min read

By Jeanne Loring There has been news over the last few days about stem cell researchers pulling out from a documentary called “The Healthcare Revolution”.  First to report on June 15 was Erin Allday of the San Francisco Chronicle, followed by David Jensen’s California Stem Cell Report blog, Michael Hiltzik of the LA Times, and Beth Mole of ArsTechnica. The documentary is a multipart series that included interviews with people designated as “Episode Experts”.  I discovered last Thursday (June 13) that I was listed …Read More

3 min read

As I broke the news yesterday, the high-profile fat stem cell clinic firm U.S. Stem Cell (USRM) just lost a groundbreaking court case. Here is the FDA’s official reaction today to the court ruling. Also, since the ruling major media have been covering the court ruling. Here are some examples: From the Washington Post from William Wan and Laurie McGinley we have FDA wins groundbreaking case against for-profit stem cell company. Michael Hiltzik of the LA Times has a blunter headline. Backing the FDA, a …Read More

3 min read

Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry. At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going to be a biological drug requiring pre-market approval, which the clinics generally do not have. The newest newspaper article comes from The Washington Post. Laura McGinley and William Wan take …Read More

5 min read

Can California stem cell clinics make questionable marketing claims about their experimental, non-FDA approved offerings as long as they are not demonstrably false? Do such clinics not bear any legal requirement to provide informed consent to patients? A new court ruling raises such striking questions. San Diego stem cell clinic Stemgenex sells non-FDA approved experimental stem cell offerings to patients suffering from a variety of conditions and last year a lawsuit was filed against the clinic on behalf of some of their customers. The proposed class …Read More

3 min read

A large and growing number of American clinics are selling stem cells to patients for a variety of ills and one in the San Diego area called StemGenex was the main focus of a recent LA Times piece by columnist Michael Hiltzik. In the piece called “These new stem cell treatments are expensive — and unproven” Hiltzik discussed the growing issues over stem cell clinics in the U.S. and he used StemGenex as a kind of test case or example. He started off with a …Read More

4 min read

When bioethicist Arthur Caplan talks about stem cells, people pay close attention and for good reason. Caplan has provided important perspectives on the stem cell field over the years. For example, you can see a guest post on this blog here about human cloning. However, in my post today I respectfully discuss how I disagree with several parts of this week’s piece by Caplan on why there are allegedly so many ethical problems in the stem cell research field. Caplan’s article (see screenshot from video at right) is focused on a question articulated by …Read More

2 min read

The LA Times has an opinion piece out today by Michael Hiltzik criticizing CIRM. It’s deja vu all over again. The LA Times has shown itself to be very biased against CIRM over the years. Hiltzik specifically has been very hostile to the stem cell agency. I see their coverage of CIRM as unbalanced, never focusing on anything positive. CIRM recently got the ball rolling on significant changes to its structure, particularly as relates to its grant approval process, in response to a review of …Read More