Friday 24 August 2012


Stemedica

Stemedica is a San Diego-based stem cell company founded in the mid nineties to harness and commercialize "adult stem cell technology and therapies for the treatment of neurodegenerative diseases." The principal movers and shakers behind the launch of this private venture were two American brothers - Roger and Maynard Howe - and their longtime Russian business partner, Nikolai Tankovich. The Brothers Howe have said they were driven to this area of medicine after a sister-in-law was severely injured in a car accident in 2004 that left her paraplegic, and after hearing of miraculous advances in cell medicine in the former Soviet Union. A compelling story...



After taking their sister-in-law to Moscow for stem cell injections in 2006, the company reported that, "Within four months, many basic life-functioning abilities began to return and [she] was able regain her independence". By the next year the Stemedica team had announced a network of international treatment centers in places like Mexico, Italy, Switzerland and France, with others to follow in Bermuda and Korea. The plan was to use various types of "adult stem cells" (apparently including fetal-derived neural cells), in combination with lasers and other devices, to treat diseases such as "stroke, Alzheimer's, Parkinson's, ischemic head trauma, spinal cord injury, diseases of the eye such as age-related macular degeneration and diabetic retinopathy as well as skin, scar and bone regeneraton"

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 was well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bankFDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.

The Regenerative Medicine Institute in Tijuana, Mexico 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 plan in which patients are told that, for $10,000-$35,000 they can buy their way into a "clinical trial". 

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". 



Stemedica's connection is as a provider of allogeneic stem cell technology for use in one such trial for stroke. The StemCellMX website, however, explains how a different Howe brother, David (who has an M.D. from Ross University in the Dominican Republic), accompanied 19 patients with serious, medical conditions like autism, muscular dystrophy, spinal cord injury and hearing loss to Moscow for similar treatments, claiming 89% improvement. The doctor in charge of these procedures was Nikolay Mironov, a member of the Stemedica Scientific Advisory Board, and the treating physician at Global Stem Cell Health (treating stroke, spinal cord injury, traumatic brain injury, Parkinson’s, Alzheimer’s, cerebral palsy, multiple sclerosis, muscular dystrophy, etc.), a company co-founded by former Stemedica director of medical servicesMichael Bayer

CMO Nikolai Tankovich, a physicist who first struck it rich with a hair-removal laser, before setting up the company Aquaphotonics and developing a bottled water product that was marketed as Penta Water; the company claimed that its structural differences from ordinary water made it better at hydration. This was likely not accurate. 


Alkhass (Amni), Schuller (Stemedica Intl., Amni)

Meanwhile, in the Rest of the World, Stemedica has continued its empire-building. 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 Forumwith W.A. Stem Cell Technologies

Maynard and David go to Shanghai
Stemedica also shows up in the logo roll on the website for Beijing's IPM Group (also known as Beijing Damcell Bio-Medical Technology), alongside the heraldry for Harvard, Oxford, and Cambridge.

Some people might see Kazakhstan as a less than obvious choice for a Phase II clinical trial, but at least two U.S. cardiologists, Nabil Dib and Jackie See, called the announced results "promising" and "impressive" in a recent press release

Nabil Dib is the director of cardiovascular research at Mercy Gilbert Medical Center in Arizona, one of the sites where Stemedica isconducting its stroke clinical trial



The Brothers Three and Tankovich co-authored a book (The Miracle of Stem Cells). 




ICMS Audited by FDA to Ensure Compliance with  Guidelines


The International Cellular Medicine Society reports that the FDA has audited its institutional review board (IRB), which the ICMS states has been asked to review "nearly two dozen study applications over the last 3 years from nearly a half dozen countries."

The group has run an HHS registered IRB for several years and it's press release states that it will be completely transparent with FDA. The agency commonly audits IRB's for compliance with HHS OHRP guidelines

Chinese company smartly invests in stem cell anti-aging

Late last year, a Hong Kong-based Caymans-incorporated company, Zmay Holdings, caught the stem cell fever, plunking down around $40 million (a total of 330 mil HKD) in bonds and equity in a deal for a technology that involves growing various types of human stem cells from ordinary somatic cells by treating them with Chinese herbs. This makes sense, as any chemical may induce differentiation in cells.

Zmay, bought the tech from inventor Xiongbin Lin.



Forty mil is big money by any measure. And the new licensees have lost no time in seeking to capitalize on their investment. The Institute of Aging Institute of Anti-Aging Medical Research on Stem Cells (Hong Kong) Limited, which was acquired from Lin as part of the deal, has recently changed its name to 159 Anti-Aging Center (H.K.) Ltd., registered a web domain, and is on a hiring spree