January 20, 2021

The Niche

Trusted stem cell blog & resources

patient adverse events

4 min read

What’s new this week in terms of reads includes a stem cell/drug combo for diabetic wonderments healing, more documentation of patient harms from stem cell clinics, and a list of recommending papers. Adult stem cells/glaucoma drug combo promotes diabetic wound healing in mice From a team of my UC Davis School of Medicine colleagues led by Rivkah Isseroff, Jan Nolta, Athena Soulika, and Thomas Peavy we have in Stem Cells Translational Medicine this exciting new paper, Combination product of dermal matrix, human mesenchymal stem cells, …Read More

5 min read

Stem cells for MS? How promising is that? A new paper gives stronger reason for hope, but unfortunately this story is more complex than it seems on first glance. New Paper The idea of using a stem cell-related approach to treat multiple sclerosis (MS) has been around for a long time holding major promise, but there hasn’t been much in the way of high-quality trial data out there in the published literature. A paper this week from the Richard Burt team at Northwestern (NW) …Read More

2 min read

E. coli is a type of bacteria that can cause diseases such as serious GI illness if it ends up in the wrong place like in your food. You can spend the night in the bathroom or end up in the hospital or more rarely a grave depending on the subtype of E. coli. Some are harmless or maybe beneficial. You can imagine that if pathogenic E. coli or similar bacteria are present in a drug product (which can include stem cells) that is …Read More

3 min read

You probably remember Liveyon. It’s a marketer of an “umbilical cord stem cell” product that was recently recalled by the FDA. The recall was due to adverse events that may have included E. coli contamination somewhere before it was injected into patients, some of whom apparently got sick. Since it seemed like this recalled product was a major part of Liveyon’s business model, some wondered: could the company survive the recall? My sense at the time was that it would just find another source for …Read More

3 min read

The FDA has issued a recall of the main stem cell product of a California firm called Liveyon that is linked to unproven stem cell clinics. The recall seems to have been due to “adverse reactions.” An emerging big player in the birth-related stem cell clinic area? I’ve been hearing the name Liveyon pop up more often in the unproven stem cell clinic industry recently. More specifically, they seem to be a supplier and marketer of birth-related products to clinics. The clinics then in …Read More

2 min read

I’m becoming increasing convinced that patient suits against stem cell clinics are going to have strong impact, including based on the new steps taken by a particular law firm. For background, I’ve written extensively about these suits over the years and we’ve seen more recently that another academic group (Claire Horner, Evelyn Tenenbaum, Douglas Sipp, Zubin Master) has published a paper on the suits. The law firm stepping up against clinics is GRYC or Grossman, Roth, Yaffa, and Cohen. They not only have and continue to represent …Read More

5 min read

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, but while US Stem Cell has drawn the most attention related to patient allegations of severe vision loss in Florida after fat stem cell injections in eyes, another group I’ll loosely call the “SCOTS Trial” has also been injecting investigational stem cells (in this case from bone marrow) into patients’ eyes and some patients have made allegations of harm there too in …Read More

4 min read

Are you a risk-taker or do you do everything possible to avoid risks? Taking risks in science is necessary, but is there a wise way to take the risks you do? Science and medicine need a certain amount of risk and risk-takers to make transformative leaps forward. The risks in biomedical science can be conceptual (a eureka! moment of a new hypothesis you are going to put out there) or more practical such as inventing a new device or method. As to the former, …Read More

7 min read

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 latter is an affiliated group of dozens of stem cell clinics across the U.S. generally marketing experimental adipose (fat) stem cell therapies, sometimes called “stromal vascular fraction” or SVF). As …Read More

2 min read

Over the years I’ve heard from quite a few patients of stem cell clinics who feel very strongly about their experiences. Some have quite positive views on getting stem cell interventions, while others feel very negatively about the stem cell clinics. I’ve heard more of the latter kind of experience. People often tell me that the stem cells from clinics only worked briefly at best and were too expensive. Another complaint is that the clinic responds to patient disappointment often by suggesting additional, expensive …Read More