I’ve been following the research related to human cloning now for more than a decade. Is human cloning more possible at this point? How do we even define such cloning? Did you know there are two types? The goal of this post is to educate you and in the process answer such questions. What’s in […]
Human cloning is more likely now but would you take the big risks? Read More »
I recently found concerning SEC filings from the biotech Cryo-Cell about a deal it has with a Duke team for infusions of children with unproven umbilical cord cells. This turns out to be a $58 million deal. It relates in a major way to a Duke compassionate use or expanded access program (EAP) that already had raised
FDA should freeze Duke EAP & probe $58 million Cryo-Cell deal linked to it Read More »
Because of blogging here on The Niche and people giving me tips I often can see trends before they fully surface and a troubling new one is intranasal stem cell delivery by unproven clinics. Over the past year I have heard of many clinics now offering this approach. I’ve seen this in marketing and heard
Clinics turning to potentially dangerous intranasal stem cell delivery Read More »
The other day I gave a talk in part about stem cell hype and mentioned as an example how the idea of already doing stem cell therapy for autism seems so misguided to me now. On the whole, in my view there are major downsides and risks for autistic kids whose parents are already having
Fact-checking stem cell therapy for autism: still a risky idea Read More »
This edition of The Niche weekly reads has a bit more good news than usual including on stem cell transplants. It’s nice to see positive developments like some recipients of hematopoietic stem cell transplants being able to stay at home afterwards. Also, a reminder. You have until July 31 to enter our stem cell video
The FDA grace period for stem cell clinics and others using regenerative medicine products like stem cells is over. It appears the agency is serious about enforcement moving forward. They have released several statements about the end of what they call the “enforcement discretion” period, which just means in English a grace period for marketers
Translating the FDA’s Q&A on end of stem cell grace period Read More »
How can you tell who to trust in the world of stem cell therapy? What information can a patient trust? Once upon a time about a dozen years ago it seemed a much simpler question. There were universities and biotech companies doing legit research as well as clinical trials, and there were physicians doing bone
Stem cell therapy: the good, the bad, & the muddy waters Read More »
Who doesn’t like stem cell videos? Some of you already know that we have a stem cell YouTube channel with me, Paul Knoepfler, talking about many important topics on stem cells. The point of the channel is science-based educational outreach to people all over the world. With this in mind, I’ve been thinking it’d be
Enter The Niche stem cell videos contest with $100 prize Read More »
The International Society for Cell & Gene Therapy or ISCT held a really interesting webinar yesterday on the FDA and unproven stem cell clinics. It was focused on the expiration of the FDA’s discretionary period on unproven stem cell clinics. What will the FDA do now? The webinar included some ideas and also quite a
New data on stem cell clinics, INDs, & more including from FDA itself Read More »
When someone uses the term “adult stem cells” you might think that simply means stem cells from adults. However, it’s not that simple. The goal of today’s post is to help you get all the key facts about adult stem cells. This includes the different types of adult stem cells and their clinical potential. What
What are adult stem cells & their clinical applications? Read More »