January 17, 2021

The Niche

Trusted stem cell blog & resources

Month: September 2019

3 min read

Every so often I realize I’ve accumulated a bunch of tabs on my browsers of things I need to dive into as time permits, which sometimes translates into a collection of recommended reads here on The Niche. Here are some recommended recent reads in the stem cell/regenerative medicine field and childhood cancer space. It includes some great science and complex social and policy developments and opinions. ‘I just want to live’: California man pleads with scientists around the world to ‘CRISPR me’. Remarkably this …Read More

8 min read

ViaCyte is one of the most exciting stem cell and regenerative medicine biotech companies so I like to try to check in with them regularly. Today’s post is my new interview with ViaCyte leader Paul Laikind on recent developments. We had a great chat about the science and how things are looking upbeat for the company, which is growing (a heads up for stem cell biologists who may be job hunting). You can read my previous interview with them from about a year ago …Read More

2 min read

This post includes my updated list of firms/products that have received FDA regenerative medicine advanced therapy designation or RMAT, which are in the public domain. The numbers really jumped in the last month. I’m assuming for the purposes of this resource page that all self-reports are accurate. Note that the links embedded into the firm names are to relevant press releases or other reference material. A special thanks to some folks at ARM for helping me keep the list up to date. You can …Read More

4 min read

What’s the deal with Michael Schumacher and his Hail Mary stem cell procedure. Usually when we hear about celebrities getting unproven stem cells, it’s the celebrity themselves or their PR machine hyping it in exchange for something like free treatments or even money from those offering the stem cells for sale, but in the past 2 weeks the buzz over the “Formula One legend” driver Michael Schumacher (see a photo of him during his racing days below) getting a stem cell treatment for brain …Read More

4 min read

This afternoon I attended and gave public comment at the Medical Board of California stem cell task force meeting on unproven stem cell clinics. There were about 40 people attending. In part this meeting is a consequence of the national governing organization of state medical boards, the Federation of State Medical Boards (FSMB) having worked on the stem cell clinic issue and crafting a policy on it. The FSMB was mentioned numerous times at the California meeting today. I’ve written before about how our …Read More

7 min read

Amongst all that is bouncing around within the stem cell clinic maelstrom out there, one thing stands out for me as the most troubling. I’m talking about for-profit experimentation on children, such as injection of kids with unproven stem cells for autism or cerebral palsy by unproven clinics. In my opinion it’s almost always going to be risky and unethical. Doing any clinical research on children requires extra care and planning even within an FDA-approved clinical trial context. Obviously pediatric clinical trials are crucial, …Read More

13 min read

A new right-to-try company called Beacon of Hope is stirring some intense discussion. State and federal right-to-try laws could potentially change the fabric of how many investigational studies are conducted. That may happen through firms like Beacon of Hope. However, we don’t know much about the firm. I’m hoping to help change that. Today’s post includes a detailed interview with the leader of Beacon of Hope, Richard Garr. For background, Garr was formerly CEO at Neuralstem. During his tenure at Neuralstem it became well-known …Read More

2 min read

How much money and how many patients do stem cell clinics like San Diego’s StemGenex make each year? A new court document has some insights from an unexpected angle. I’ve been following StemGenex for years here on The Niche. It’s been a rollercoaster ride. Things hit a new low today, perhaps marking the operational end of the company, but we’ll see. StemGenex has marketed non-FDA approved fat stem cells for a variety of health conditions. Their marketing is central to a patient class action …Read More

4 min read

As part of its stepped up approach to unproven stem cell marketing, the FDA issued another warning letter to a perinatal (birth-related) stem cell supplier. It’s interesting to see the FDA doing more specifically about suppliers and not just focusing on clinics. It seems that in some subsectors of the stem cell arena that certain suppliers are strong driving forces behind more patients being put at risk. Also, each supplier may enable dozens of clinics so there’s some logic here to the FDA putting …Read More

2 min read

US Stem Cell, Inc. reports in a new SEC filing that its key leader Kristin Comella has resigned as of September 1. I never thought I’d see the day when Kristin Comella and US Stem Cell, Inc. parted ways. To me Comella seemed like the driving force behind the company, which is now subject to an injunction after a big federal court loss. It is appealing the ruling, but faces a tough road ahead in my view. From the new SEC filing: “Effective September …Read More