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 »
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 »
The website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex. Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case
Update on patients lawsuit against stem cell clinic, Stemgenex Read More »
What happens for patients and clinics after a stem cell facelift gone wrong? What about other cell injection problems? Cell therapies raise new challenges and risks. You can stop taking a pill or an injection treatment. However, you can’t stop or retract stem cell treatments if there’s a bad side effect. Unlike other kinds of
Clinics can’t retract problems like stem cell facelift gone wrong Read More »
Each year I make a list of predictions for the stem cell and regenerative medicine field for the coming new year. Later in this post I list my top 20 stem cell predictions for 2017. In looking at my past predictions I realized this will now be my 7th year doing stem cell/regenerative medicine yearly predictions.
Stem Cell Predictions for 2017 Read More »