The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted …
Even as some unproven, for-profit stem cell clinics promote themselves aggressively in many ways including now on TV, on the flip side lately we’ve seen more TV journalists covering questionable marketing by the clinics and negative patient outcomes. Today I saw that CBS This Morning, a national broadcast, had a fairly long TV segment on stem …
What is the SCOTS Trial and why are some of its participants raising concerns? There’s a lot going on in Florida with non-FDA approved stem cell offerings. Even just related to stem cells for vision problems alone. While US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida …
15 still unanswered interview questions for stem cells for vision SCOTS trial docs Read More »
What’s the deal with dragonfly eyes? They are so huge! We’ll zoom in on them. Do bees bite? Yes, but not the way you might think. Growing cool tomatoes? I have some thoughts on that too. I’m a scientist and a gardener so it’s not surprising I write an occasional series here on The Niche …
Scientist in the garden: dragonfly eyes, bees bite flowers, cool tomatoes, & tips Read More »
Hi Readers — Since 2017 we have had an official privacy policy for this blog, The Niche. We want you to be aware of this, particularly as relates to the new General Data Protection Regulation, or GDPR law in Europe. You can read the policy here. The key overall point is that I want you to …
The world is constantly bombarded these days with often-hyped stories of the latest celebrities who got unproven stem cells, including most recently Jack Nicklaus and now Tarek El Moussa of Flip or Flop TV real estate fame. Both these celebs got stem cells for orthopedic kind of health situations, but while in theory stem cells …
Tarek El Moussa stem cell shot, a flip or a flop? Risks of celeb buzz Read More »
Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? …
When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon? Read More »
Where do things stand with IPS cell translational research? The newest development is that regulators in Japan just have given conditional approval to an Osaka University team to an induced pluripotent stem (IPS) cell-based study for ischemic heart disease. For years IPS cell-based products have been on-again off-again in active clinical study for macular degeneration, work …
Japan conditionally approves new IPS cell-based heart study Read More »
California broke new ground with our stem cell law that went into effect on January 1. It requires stem cell clinic firms to post notices informing patients of important information such as the fact that their offerings are non-FDA approved. At this point, 4+ months into the enforcement period, I’m not sure if anyone has …
Update on state laws on stem cell clinics: California, Washington, & Florida 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 »