Monday, November 6, 2023

#2700: Kristin Comella & Theodore Gradel

Stem cell quackery is a serious problem. Stem cell clinics preying on people in difficult situations with ‘experimental’ but non-evidence-supported and often nonsensical cures for various serious conditions, have been popping up all over the US (and Mexico) over the past fifteen years, and some of them have even received boosts from mainstream media in the form of anecdotes reported as miraculous” recoveries from serious disease. Now, people suffering from serious diseases are often willing to try almost anything, and they are accordingly easy targets for cynical grifters and delusional woomeisters with unproven techniques – after all, the grifters don’t need to offer any promises; a glimmer of hope may be sufficient to ensure that people with serious diseases sacrifice their savings as they also often lose their lives.


There is little protection to be had against such businesses, but in 2018 the FDA at least cracked down on two of the most obviously bad actors using unapproved stem cell treatments that had seriously harmed patients: at those clinics, fat was removed from patients’ bellies by liposuction and then an extract of it was injected into various parts of the body, like knees or the spinal cord, based on the (unsupported) conjecture that the extract contained stem cells that could provide replacement cells that would repair damage from injury or illness. One of the targets was the U.S. Stem Cell Clinic L.L.C. of Sunrise, Florida, its chief scientific officer, Kristin Comella, and its co-owner and managing officer, Theodore Gradel. (The other target was the California Stem Cell Treatment Center, including the Cell Surgical Network Corporation of Rancho Mirage, and Dr. Elliot B. Lander and Dr. Mark Berman)


In fact, the US Stem Cell Clinic, LLC, offers not just stem cell quackery but a whole cornucopia of quack techniques, including food allergy testing, IV nutritionals, ozone therapy, and infrared therapy. But with regard to its stem cell procedure, the clinic claimed, with little to no evidence, that the procedure could be used to treat a wide range of conditions, including Parkinson’s disease, amyotrophic lateral sclerosis, chronic obstructive pulmonary disease, heart disease, pulmonary fibrosis, Crohn’s disease, lupus, and diabetes. The FDA had also prior to 2018 not been particularly impressed. (It’s worth noting that the clinic put in serious efforts to prevent the FDA from carrying out an inspection, for instance denying them access to employees, and yeah, the administration at the clinic clearly has some serious problems with honesty.) The FDA’s focus on the clinic was motivated in part by the clinic’s aggressive marketing strategies and demonstrable patient harm, e.g. three women who lost their vision after “stem cell treatmentfor macular degeneration – and yeah, the clinic’s practices were truly egregious; more details here, and even more here. (Note, too, that there are no reporting requirements for adverse effects outside of clinical studies, so similar harm from stem cell treatments may be way more common than we realize.)


Kristin Comella is the clinic’s “chief scientific officer”. According to her website, she is a “world renowned expert on regenerative medicine with a focus on adipose derived stem cells” but her academic background consists of an MA in chemical engineering and a “Ph.D in Stem Cell Biology” from the Panama College of Cell Science, an unaccredited offshore virtual college where you can buy a PhD degree for $8100 (they promise you a degree “beautifully created in color in the approximate size 8 x 10 inches, using various fancy font styles”). Comella is also the founder and president of the Academy of Regenerative Practices, a position she uses to call for donations to create a “legal defense fund” to fight the FDA; “in fields where you’re starting to do a new paradigm and bringing something forward that is a disrupter,” she said, “there’s always going to be naysayers”. Well, there will certainly be naysayers when what you do is causing irrepairable harm to patients through quackery, too. Comella relies on her potential customers to not consider that possible explanation for nay-saying. Her pitch has in any case made her a sought-after speaker at health industry conferences and conferences of longevity quacks, such as the annual Revolution against Aging and Death Festival.


An interesting tidbit: The unaccredited Panama College of Cell Science was founded by Walter Drake, a onetime cancer researcher who claims – conveniently for Comella –  that treatments involving reinjection of a patient’s stem cells shouldn’t be subject to clinical trials; and Drake’s relevant credentials for the claim? A “PhD in stem cell biology” … from his own unaccredited institution, no less.


Diagnosis: Yeah, so ‘loon’ might not immediately come across as the most accurate epithet, but if we apply Hanlon’s razor, then that’s what we end up with. Dangerous.


 Hat-tip: Respectful Insolence

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