“We are in a grey area, regulatory-wise as to what we can do with our own stem cells,” says John Arnone, chairman and CEO of Eatontown, N.J.-based American CryoStem. “The rules have not been fully established yet.”
Mr. Arnone notes the industry is still in its infancy, and the U.S. would benefit to look globally for guidance. He points to Japan as the most progressive country for regenerative medicine, as smaller companies can more easily initiate clinical studies and introduce a product to market.
“I do believe the U.S. is going to come up with a regulatory structure shortly that will allow smaller companies to participate and bring inventions to the market in a cost-effective manner,” he adds. “The U.S. recognizes it’s getting behind the world in this regenerative medicine and it’s because of excessive regulation. This excessive regulation is costing the U.S. economy billions of dollars in revenue to countries more advanced in medical tourism, an accelerating trend that is unlikely to change in the near future without regulatory reform.”
American CryoStem, or CRYO, has successfully made its way through the maze of regulations. Founded in 2008, CRYO built its laboratory processing operations under available FDA guidance and holds 18 patents for its technology. The company collects, processes and stores pure adipose tissue and adipose tissue derivatives for current or future use in regenerative medicine. CRYO has a network of approximately 200 surgeons and works with universities and private companies to develop regenerative medicine applications. In addition to its main New Jersey laboratory facility located in Princeton, N.J., the company has affiliated licensed facilities in Hong Kong, Tokyo and Shenzhen, China.
Provider physicians receive collection boxes filled with CRYO’s transportation medium to return patients’ harvested tissue. Once received at its FDA-registered clinical laboratory, CRYO processes the lipoaspirate in line with the physician’s instructions.
“Our real expertise lies in our laboratory process; once we receive the adipose tissue from patients we process it to the stromal vascular fraction, we are then able to expand the Mesenchymal cells and store them or differentiate those cells if requested,” says Mr. Arnone.
He believes the great opportunity in the field is regenerative medicine applications. CRYO has patented 14 lines of stem cell mediums in the areas of growth, transportation, storage, differentiation and more.
He emphasizes the company only uses a patient’s own material to create a autologous product — a model they’ve used since the company’s beginning.
“Over time, you’re going to see this being one of the largest industries in the world,” Mr. Arnone says. “It’s going to be common place, with people using their own stored biological material to heal and repair themselves.”
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