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| The Stemedica Three |
A visitor to the Stemedica website circa 2007 was also greeted with an impressive list of institutional "strategic relationships" sporting the logos of Stanford, UC Irvine, and the Burnham Institute, among others.
By 2009, the company website had removed all mention of treatment centers and Stemedica was well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bank, FDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.
But when you're talking about overseas treatment/profit centers, gone does not necssearily mean forgotten, and Stemedica continues to have unusually cozy relationships with a number of clinics outside the US that openly advertise stem cell injections for a thick catalog of afflictions.
The Regenerative Medicine Institute in Tijuana, Mexico (which I have blogged a bit about before) is just 30 miles south of the Stemedica office. The first clinic to be accredited by the ICMS, the RMI (which is set up within the Hospital Angeles Tijuana medical tourism operation in Mexico) offers stem cells for dozens of conditions, from cerebral palsy to frailty syndrome, under a novel business scheme in which patients are told that, for $10,000-$35,000 they can buy their way into a "clinical trial" absent many of the features like controls, randomization, or blinding that would actually make it possible to generate any scientific insights into the efficacy of the investigational product.
The institute's StemCellMX website encourages users "To find out if our trials are right for you please contact us using the form on the right". Essentially, they ask their customers to be subjects in medical experiments, but to pay as if they are receiving therapy. Some have begun to complain.
The link between Hospital Angeles and Stemedica goes back at least to the 2007 list of Licensed Treatment Centers on the Stemedica website (and even today, Cesar Amescua of Grupo Angeles is Stemedica's medical and regulatory affairs director for Latin America). Also on the 2007 list is the Brown-Darrell Clinic in Bermuda, which was slated to be launched in 2008 in collaboration with Ewart Brown, then-Premier of the island nation, and his wife Wanda. The opening had to be postposed after a local media firestorm ignited over the propriety of opening a stem cell hospital in a country in which medical regulations for cell therapy were not in place, and the Brown-Darrell clinic vanished from Stemedica's site. Five years later, no such guidelines have materialized and the controversy simmers on.
During the 2007 hubbub, the Bermuda Sun earned itself a heartfelt hat-tip for doing background and fact checks on key players at Stemedica. They revealed that CEO Maynard Howe, Ph.D. was a "marketing expert with a Midas touch" who had made tens of millions from the sale of an anti-wrinkle laser, at a company in which Roger and David Howe and Nikolai Tankovich were also all partners (as was Roger's son Derek, the VP of operations at Stemedica at that time). The Sun reported that Maynard was also chairman of a nutraceutical company selling something called Nanogreens (the healthy fast food!).
The Sun also cast light on CMO Nikolai Tankovich, a physicist who first struck it rich with a hair-removal laser, before setting up the company Aquaphotonics and developing a
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Alkhass (Amni), Schuller (Stemedica Intl., Amni) |
Meanwhile, in the Rest of the World, Stemedica has continued its empire-building and regulatory arbitrage overseas. In recent years, they have inked a deal with Jordanian Stem Cell Company, chaired by Prince Asem Bin Nayef of Jordan, and partnered with Amni BioScience, a Middle East regional biz headed by fellow San Diego citizen Sam Alkhass (who also brokered the Jordan alliance), and counting Tankovich and David Howe, as well as Stemedica International chief Frank Schuller, and Mark Tager, Stemedica executive for dermatological operations, and another 'nother Howe brother, Bruce, on its team.
Stemedica is popping up all over Asia, entering a joint venture with AnC Bio in Korea, and launching Stemedica Asia in Singapore. In China, Maynard and David held an Educational Forum with W.A. Stem Cell Technologies, a company recently exposed in a Nature article that detailed how its medical tourism arm offers a double dose of stem cells (adipose, cord blood) for autism for 250,000 RMB (around $40,000), in apparent violation of the Chinese Ministry of Health's efforts to rein in over-the-top claims of stem cell efficacy. W.A. is headed by Shu Li, a former engineer who also goes by the name of Taichi Tzu, holds a patent on negative gravity therapeutic methods, and has "been practicing Taoist alchemy for over 15 years."
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Maynard and David go to Shanghai |
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The release also fails to mention that Jackie See, himself a member of the physician team at California Stem Cell Treatment Center (which offers stem cells for (among others) asthma, hair loss, incontinence, MS, kidney failure and Peyronie's disease), has been in trouble in the past for scientific fraud. In 1999, the LA Times reported how Harvard Scientific, a company at which he was director for research, got into trouble with the FDA for submitting "misleading and erroneous information about a clinical study" for an agent being tested for treatment of sexual impotence. Predictably, this hurt Harvard Scientific's share price, triggering an investor suit against See (RK Company v See). According to the circuit court ruling, the court "repeatedly described Dr. See's testimony as not credible," and the plaintiff (who was himself in prison at the time on bribery and racketeering charges) won.
The press release also neglects to disclose that Nabil Dib is the director of cardiovascular research at Mercy Gilbert Medical Center in Arizona, one of the sites where Stemedica is conducting its stroke clinical trial. It further omits Dib's former role as chief of staff in the stem cell transplant clinic at Stowe Biotherapy. The proprietor of that business, Larry Stowe, surrendered to authorities this January after 60 Minutes caught him and his then-partner Frank Morales offering stem cells and tall tales to an ALS patient, on camera.
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We're in the business of miracles |
Riccardo Nisato, Director of Manufacturing and Clinical Business Development at Stemedica International, did in fact drop the F (for "fetal") bomb in a single comment announcing his appointment back in 2009, which Stemedica's neglecters seem to have neglected to neglect but, to be fair, he was still new back then and may have missed the memo.
The sister-in-law whose accidental paralysis kicked off this latest family venture died back in 2009. But while she was still living, a local magazine reported that, despite the hype, "an MRI performed in June revealed that the stem cells had not repaired her spinal cord." In the end, she attributed her perceived progress "to God."
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