It is always exciting when a biomedical technology as revolutionary as iPS cells is on the cusp of being used in patients for the first time. In the last few days stories have reported about how a proposed clinical trial based on iPS cells has completed several regulatory steps and is closer to starting. This […]
The Korean-based stem cell biotech, RNL Bio, which also does business in the U.S. as RNL Bio and Human Biostar Inc, reportedly (seems to be a press release, PR) has filed an investigational new drug (IND) application with the Korean FDA (KFDA). The purpose of the application is to test the efficacy of autologous adult stem cells
A big issue in the stem cell field is that firms increasingly are doing business in multiple countries. Associated with the increasingly international nature of the stem cell for-profit industry are emerging legal and ethical issues related to the transport of stem cell-based biological drugs across international borders. Think you can just FedEx human stem
I’m on a roll with my stem cell predictions for 2013 (see all 10 here). First, I got it right with my #1 prediction that the Supreme Court would take a pass on the Sherley v Sebelius Case. Now, I read from excellent science writer David Cyranoski at Nature that Celltex is going to be
Stem cell predictions coming true: Celltex moves to offer transplants in Mexico Read More »
Recently, the Institute of Medicine (IOM) conducted a review of the California Stem Cell Agency, CIRM. IOM has now released a quite lengthy report that makes a number of recommendations on various issues. You can also read a short summary here. Unfortunately, I think that many of the IOM recommendations would be harmful to CIRM
IOM misses the boat on CIRM board Read More »
I’m doing this series called “The Elephant in the Lab” where I discuss controversial or taboo laboratory topics that people are usually too afraid to publicly discuss. I started with iPS cells (for a description and definition of iPS cells go here) and now have updated this post for 2013 because the field is changing rapidly. iPS
Taboo topics about iPS cells: updated for 2013 Read More »
Advanced Cell Technology (ACT) is well into clinical trials for macular degeneration (the leading cause of blindness) using human embryonic stem cell (hESC)-based retinal pigmented epithelial cells (RPE). To date, the trials suggest the products are safe. Efficacy? We don’t know. I am cautiously hopeful, but it is frustrating to know that most clinical trials
Every now and then a paper on stem cells lands many international headlines and also captures people’s imaginations. This seems to be the case for the recent urine stem cell paper from a team in China, which has made huge headlines. In addition to mainstream media, the paper was covered in Wired here and also by one
Why did urine stem cell paper create global media sensation? Read More »
What’s the big deal about unproven stem cell treatments, patients often ask me. Why should patients avoid these? Because paradoxically such treatments, intended to cure disease, can have devastating negative consequences for your health. I’m doing an eight-part series, “Eight simple reasons not to get a stem cell treatment”. The first two blog posts were
The field of induced pluripotent stem cells (iPSC) has really shaken up science over the last half dozen years reversing our notion that differentiated cells are stuck in that fate, when in reality they are plastic and can “turn back the clock” to become embryonic stem cell-like cells. Now we have an iPSC paper in Nature,
Surprising human genomic mosaicism means not all your cells have the same DNA Read More »