The Food and Drug Administration is beginning to worry about how to regulate cells and organs for transplant, something that has traditionally been left to doctors to decide.
Up till now, the practice of transplantation has been considered a practice of medicine, something the FDA does not regulate.
“(Organs and cells) are not a product, not a traditional drug,” said Dr. Philip Noguchi, chief of gene therapy for the FDA. “The question is when to regulate cells themselves.”
The FDA oversees a limited number of cellular transplants-for example, making sure that blood and insulin are safe. But now researchers are testing animal organs in humans (xenotrans-plantation), and the use of cells for injection like medicine. The FDA is now forced to question whether these are things that transcend routine medical practice. And if they are not performed safely, are these procedures that could endanger public health?
“They have to protect the population,” said Glen Spaulding, a xenotransplantation specialist at Tufts University. “It’s getting more complicated very fast.”
There are many trials going on right now, involving the treatment of a host of chronic illnesses. In fact, there are five companies harvesting pancreatic cells from pigs for use in islet transplants. Some companies are even creating cells by breeding animals with human genes.
“These things could take off very rapidly,” Noguchi said. “We must be ready.”
Noguchi said that there will be a time when doctors can mix and match cells, creating customized biological therapies for individual patients.