When you think of Florida, what else crosses your mind first? Orange juice? Heat and humidity? Beaches? Disney? I don’t know if this says more about me or the state, but these days I think of stem cells. Florida and California are the two biggest hotbeds of the for-profit stem cell clinic world, each with […]
Sentinel Takes Investigational Deep Dive into Florida Stem Cell Clinic Soup Read More »
Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The
US Stem Cell bid for FDA RMAT rejected? Read More »
In December of each year I make a list of stem cell predictions for the coming year, and I made 20 such predictions for 2017 so I’m wondering how I’m doing so far on these now that it’s June. Below is my work-in-progress scorecard for these so far. Positive news from Asterias on trial for stem cell-based
2017 stem cell predictions: score card at 1/2-way point Read More »
The civil lawsuit against Stemgenex here in California was substantially narrowed by a judge and some of the judge’s comments were surprising in suggesting limitations in how patients may respond to stem cell clinics or other businesses if they are unhappy enough to consider filing suit. For more on the court’s ruling see my previous
California legal expert weighs in on court ruling in Stemgenex case Read More »
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
Narrowed Stemgenex suit proceeds as court implies stem cell clinic loopholes Read More »
Stem cell clinic biotech Stemedica has just been sued by one of its own board members based on allegations related to money the company raised, according to CourtHouseNews. The actual suit, filed by an investment company Tiara Holdings and board member Anthony Marlon, can be read here. CourtHouseNews writes: “Tiara Holdings II LLC sued Stemedica Cell
Stemedica sued by board member over alleged mishandling of funds Read More »
The world of stem cell clinics is on edge right now with a number of negative patient outcomes reported and lawsuits in play such as San Diego stem cell clinic Stemgenex being a defendant in a proposed class action lawsuit focusing in part on alleged problematic marketing claims on their website (see archived posts on the lawsuit).
LA Times Reports Stemgenex Doc Gets 3-Year Probation from State Medical Board Read More »
Do three blinded US Stem Cell clinic patients with major or complete vision loss constitute a significant adverse outcome? I would say so and a new paper details how this happened apparently at a particular publically-traded South Florida stem cell clinic business. You can see the damaged retinas of one such patient below in an image
NEJM paper links 3 blinded patients to US Stem Cell clinic Read More »
The stem cell clinic business US Stem Cell Inc., formerly known as Bioheart, has seen its stock take a rollercoaster ride recently include a big run up and now today a big drop so what’s the scoop? US Stem Cell, which includes a few subsidiaries such as US Stem Cell Clinic, focuses on the use
What’s the deal with US Stem Cell Inc stock? Read More »
What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its
Tom Price & MiMedx: a stem cell connection? Read More »