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Perspectives: FDA warns umbilical firm & continues stream of “mini-warning” letters

April 4, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

umbilical-cord-blood, umbilical cord blood stem cells

Yesterday we learned that the FDA issued a warning letter to the cord stem cell firm, Cord for Life. In this warning, the FDA indicated that the firm’s product is actually a drug product and lacks necessary pre-market approvals. In addition, the agency highlighted apparent deviations from CGMP practices. The most important part of the […]

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KING 5 TV pulls odd Swedish Medical regen med infomercial off YouTube

April 2, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Swedish-Adam-Pourcho-Regenerative-Medicine

Some unproven stem cell clinics just make things up, but when a big medical organization like Seattle’s largest nonprofit health firm, Swedish Medical Group, has a marketing segment on TV with what in my view are odd and inaccurate claims related to regenerative medicine, the negative impact could be far greater. The segment in question

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Have you given up on your local paper? I might with The Sacramento Bee

March 5, 2019 / Professor Paul Knoepfler, Ph.D. / 7 Comments

For more than a dozen years we’ve subscribed to The Sacramento Bee newspaper here in Northern California. During those dozen+ years, newspapers across the U.S. have been under huge financial pressures. At a science level, one of the terrible results of this pressure on newspapers has been the vast number of excellent science writers who

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Counterpoints to Lovell-Badge & Daley’s CRISPR baby rationales

February 11, 2019 / Professor Paul Knoepfler, Ph.D. / 5 Comments

Two prominent scientists, Robin Lovell-Badge and George Daley, have been amongst the most outspoken proponents of leaving the door open to heritable human genetic modification via CRISPR. While they each have articulated their reasons in somewhat different ways at times, their core reasons arguing in favor of future heritable CRISPR appear largely the same. In

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‘So you don’t get eyeball in your hand’: Swedish Medical Center ‘infomercial’

February 4, 2019 / Professor Paul Knoepfler, Ph.D. / 16 Comments

Swedish Medical Center in Seattle is now marketing regenerative medicine therapies including some things that in my view are not really scientifically proven to work including via an infomercial. This is part of a bigger trend where more legit medical centers have begun selling regenerative medicine “treatments” that are still being developed. Sometimes they even

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When the state & ‘rogue’ scientists collide: case of China & CRISPR baby guy He Jiankui (贺建奎)

January 6, 2019 / Professor Paul Knoepfler, Ph.D. / 4 Comments

What happens next to He Jiankui (贺建奎) or as some people now refer to him, the “CRISPR baby guy”? China has a challenging situation to resolve here, but such conflicts between scientists and governments have happened regularly in history. When scientists go “rogue” (i.e. don’t conform to norms or ethical standards in an extreme way or

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Trying to connect the dots on CRISPR baby story paints a dark, cloudy picture

November 27, 2018 / Professor Paul Knoepfler, Ph.D.

When I was a little kid I played this game called “connect the dots” or “dot-to-dot”, where you draw a line from dot-to-dot in numerical order and at some point a picture starts to emerge. I think kids and even some adults still play this today. They even come in extreme versions with hundreds or

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Hope on Parkinson’s front: Japan IPSC trial 1st patient

November 18, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Fig-3i-Kikuchi-et-al.-Nature-2017-IPS-cell-Parkinsons-

In Parkinson’s Disease patients develop neurological dysfunction as they lose a special kind of brain cell called dopaminergic (or dopamine) neurons. While a number of different approaches to this disease have been studied for decades, nothing has proven particularly successful in slowing its progression. As a result there has been a big need for novel thinking

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Report a bad clinic

November 8, 2018 / Professor Paul Knoepfler, Ph.D.

The stem cell clinic industry selling unapproved “therapies” is ubiquitous and yet somehow still growing it seems. Many of us are encountering more of them including via ads and the clinics are basically all over the place. What should someone do if they see or have had a bad experience with a stem cell clinic

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Magenta Therapeutics Good News-Bad News Trial Data

November 4, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Magenta Therapeutics is a biotech company with a portfolio including stem cell products. Their most well known investigational drug product is an expanded umbilical cord stem cell product called MGTA-456, an “ex-Novartis” product. Magenta just released new trial data on MGTA-456, which I see as a case of good news-bad news, and investors seem to

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