Stem cell consultant touts high ethical standards

Thu, Aug 11th 2016, 11:49 PM

As The Bahamas continues to pursue the development of a stem cell industry, just next door the number of U.S. stem cell clinics operating in violation of Food and Drug Administration (FDA) guidelines has reached nearly 600. And while some are questioning the ethics of therapy based on admittedly scarce research, Okyanos Cell Therapy Patient Consultant Dr. Moira Dolan told Guardian Business that The Bahamas' National Stem Cell Ethics Committee ensures that stem cell therapy is being practiced at a high standard.
She suggested that stem cell research will be continued in The Bahamas.
In a recent article by Gina Kolata, writing for the New York Times' "The Upshot", the author reported that over the past two to three years, 570 stem cell clinics have opened in the United States offering "untested stem cell treatments for just about every medical use imaginable". Kolata also noted that stem cells might in theory be a useful treatment for certain diseases that involve the loss of cells like Type 1 diabetes, Parkinson's or osteoarthritis.
The New York Times author asked, "So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of -- sports injuries, arthritis, autism, cerebral palsy, stroke, muscular dystrophy, ALS, cancer?"
Dolan, who is also a doctor of internal medicine, acknowledged that commercial clinics offering to treat systemic disease using stem cells in the U.S. are unregulated at this point.
"There is no entity monitoring what they are doing and they are operating in frank violation of FDA guidelines," she said.
She explained why conducting stem cell therapy in The Bahamas is fundamentally a beneficial opportunity for the country.
"Being just a short flight from the U.S., The Bahamas presents a unique opportunity in both proximity as well as recent stem cell legislation for stem cell providers who wish to offer the therapy to patients in a tightly regulated 'by-the-book' jurisdiction.
"The Bahamas' National Stem Cell Ethics Committee has maintained a commitment to licensing providers who are practicing cell therapy at a high standard and who meet the application standards, which requires that significant scientific rationale be provided for the therapies offered to patients. Healthcare research is and has leaned towards harnessing the power of your own biology to address chronic conditions for many years.
"Stem cell therapy is the next phase in the evolution of medicine and it holds great promise for treating chronic disease in a minimally invasive way," said Dolan.
According to research, adult stem cells are a full grown body's repair and regenerative mechanism. They are able to turn into replacement cells, make more of themselves and secrete healing substances specific to an injury or disease.
Published research including clinical trials on stem cells number into the 200,000s. Further, there are more than 40,000 medical reports on mesenchymal stem cells alone -- the class of stem cells found in fat tissue -- and hundreds of clinical trials which support the reparative and regenerative effects of these cells and their use in the treatment of chronic, degenerative diseases.
The Food and Drug Administration allows clinics to inject patients with their own stem cells as long as the cells, or the tissue the cells are extracted from, meet specific criteria, including "minimal manipulation", and are intended to perform their normal basic function. But even if treatments the clinics advertise seem questionable, the FDA cannot act based on a website.
Parallel to the United States' involvement with stem cell research, government officials from a Caribbean state in connection with an alleged stem cell project frowned upon allegations of conducting a stem cell research project in the nation's local hospital.
Bahamian permanent resident and controversial fashion mogul Peter Nygard made an attempt to be a stem cell entrepreneur in St. Kitts and Nevis, where he is reported to be behind a scandal at the island nation's Joseph N. France General Hospital.
Nygard's involvement reportedly led to former St. Kitts and Nevis Prime Minister Dr. Denzil L. Douglas to demand the resignation of Prime Minister Timothy Harris and Health Minister Eugene Hamilton.

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