An Insider’s Antidote for Dangerous Stem Cell Hype

Xconomy San Francisco — 

UC Davis professor Paul Knoepfler’s new book about stem cells may never break into the New York Times best-seller ranks, but he still might make some publishing history.

Knoepfler could be the only biology researcher ever to write a comprehensive consumer guide about the health care treatments being developed in his own field—complete with safety cautions.

Stem Cells: An Insider’s Guide is also a scientific primer and a paean to the promise of stem cell research. But Knoepfler, whose 370-page book originated as a blog about his field, also wanted to protect the thousands of vulnerable patients who have prematurely looked to stem cell therapy as a last-ditch hope for a cure.

His greatest concern is for patients who have been lured by the false claims of dubious for-profit clinics to pay as much as $100,000 for unproven “stem cell treatments.” These injections, he says, may actually consist of cells culled from pigs, cows, or sheep, and bear unknown risks such as contamination or immune system reactions.

A growing network of secret online communities, as well as overt advertisements, have spurred US patients to pay fortunes out of pocket to ill-trained physicians, who perform experimental procedures backed by little or no evidence, says Knoepfler, an associate professor and researcher at the UC Davis School of Medicine’s Institute for Regenerative Cures.

“The number of patients being treated, and the number of providers, are increasing,” Knoepfler says. “I don’t think the FDA has the budget to deal with this.”

But Knoepfler’s book is also aimed at patients who are eager to enter FDA-approved clinical trials, confident that stem cell treatments will soon deliver miracle cures with few downside risks.

“One of the motivations for my book is letting people in on some of the realities,” Knoepfler says.

Knoepfler's book is published by World Scientific.

Knoepfler’s book is published by World Scientific.

Knoepfler tells patients what many of them don’t want to hear—that very few stem cell therapies have yet been proven safe and effective, although thousands of clinical trials are under way. What’s more, testing those therapies requires even more careful safety monitoring than many other kinds of treatments, he says.

Stem cells pose unique risks because they are alive and can in theory grow inside the body, which makes them very different from most chemical or biologic drugs, Knoepfler says. Patients who have a bad reaction to a drug can stop taking it, and the body will eliminate it, he says.

“If you get injected with a billion living cells, the truth is, we really don’t know what happens after that,” Knoepfler says. One of the possibilities recognized by researchers is that the stem cells may eventually initiate the growth of a tumor—an issue that Knoepfler explores in his own lab at UC Davis.

That said, Knoepfler thinks the promise of stem cells will prove out, given enough time to carefully work out the bugs.

“I’m very optimistic about the stem cell field,” he says. “I think it will transform medicine in the coming decades.”

In his book, Knoepfler starts out with … Next Page »

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8 responses to “An Insider’s Antidote for Dangerous Stem Cell Hype”

  1. Alberto Salazar says:

    Once again, a researcher who feels safe to side with the FDA contrary to those
    researchers apprehensive to contradict Dr. Knoepfler’s claim that the FDA is
    not right to claim that autologous stem cells from a patients own body is a
    drug but a medical procedure, the repercussions of losing funding when contradicting
    the FDA is too much of risk. We can have thousands of riskier procedures like
    heart transplants, bone marrow transfusions, etc. as medical procedures and
    adhere to medical state boards, but Dr. Knoepfler along with those that side
    with the FDA have captured a medical procedure in an unrealistic realm of
    expensive FDA drug clinical trials believe it belongs in this paradigm which
    does not. Meanwhile, thousands of patients wait in the sidelines ill. Dr.
    Knoepfler’s constant campaign to defend the FDA is doing a total disservice to
    the ill and terminally ill.

  2. HeraSentMe says:

    PK is certainly no hero, no patient advocate, etc. He posts his self-aggrandizing, megalomaniacal, tabloid style blog posts purely for shameless self-promotion. Here is one example of a REAL patient advocate:

  3. HeraSentMe says:

    See Dr. Chris Centeno for someone truly worthy of praise!

  4. HeraSentMe says:

    All the members of Patients For Stem Cells and Stem Cell Pioneers are the ones fighting daily, not only for their lives, but also, for the lives of others… while PK posts absurd tales worthy only of the Enquirer! And as PK is so busy feeding his ego, he seldom publishes any research papers. Where does all that CIRM, taxpayer funded $$$ go?

  5. HeraSentMe says:

    Ms. Tansey, you should do your homework before praising a fraud like PK.

  6. Zchick1836 says:

    As an adult stem cell patient for MS the United States lags way behind in biologics. A patients own stem cells taken from their own body have been proven safe with thousands and thousands of patients. Those who aren’t on board with the idea of a patient being treated with their own stem cell for disease/conditions have many reasons why….Research $$$’s to their universities would dry up, book deals would disappear, speaking engagements would vanish, ego’s would be bruised, jobs would be at stake. Some scientists have put all their eggs in one basket. If a scientist could create a bio-equivalent product or a generic, say an iPC cell, then it could be sold to the public as a drug marked up x100. This would make the FDA happy, the pharmaceutical companies quite happy but leaves “NO OPTION PATIENTS” hung out to dry in the “valley of death” waiting at a chance for quality of life improvements. As a friend of mine, SammyJo Wilkinson, who is also a very public activist for adult stem cell treatment said best…”Paul, while you’ve got your head in the clouds, (referring to an article that PK wrote) physicians are down in the trenches everyday with suffering patients. We support Dr. Centeno an true advocate for patients because he recognized, then documented the higher efficacy stem cells offer to patients. Then he stood up to the overzealous regulators. We’ve had the safety argument with you over the past year and a half, autologous MSCs, even expanded, continue to mount a strong safety profile as in Centeno’s reports, and in University phase 1/2 clinical trials. It’s time to bridge this divide. Join us in the call to allow physicians to to practice medicine with expanded cells. Our own stem cells are like homemade clothes. There will be time for designer ipsc’s, but what MSCs do naturally should be fully examined and understood first. Patients treated with their own cells should be the benchmark against which man-made cell therapies are measured.” Anyone can call them self a “patient adcovate,” but ask patients who we think the true patients advocate are, and you’ll hear names like Dr. Chris Centeno, Dr. Neil Roirdan, Dr. Doug Broeska and Dr. Camillo Ricardo. Adult stem cell patients have bonded together and formedhttp://www.patientsforstemcell/… We feel our civil rights have been violated!

  7. Zchick1836 says:

    Why would you not post my comments when they were stated politely? I’m just of a different opinion and that’s not allowed? You’ve left some other nasty comments up but taken mine down? WOW! Please be a fair and unbiassed journalist. Thanks! Jennifer Ziegler