FDA Report Outlines Approach to Personalized Medicine

Miriam E. Tucker

October 29, 2013

In This Article

Autologous Cell Therapy

Carolyn A. Wilson, PhD, associate director of research, Center for Biologics Evaluation and Research, described the FDA's approach to autologous cell therapy, a personalized medicine technology that has not yet been tested in humans but is viewed as holding great potential for creating individualized therapies.

Induced pluripotent stem cells are "really the ultimate personalized medicine," she said, explaining that the cells are grown from the patient's own body, grown externally, manipulated in vitro to an embryonic state to create a therapeutic product, and returned to the patient. Such processes could be used to treat conditions such as leukemia, Parkinson's disease, and diabetes.

The FDA's intramural research program has developed a proactive consortium of researchers who are determining how to regulate such products, taking a systematic approach to look at measurable characteristics of the products and correlating them with functional outcomes in animals and in vitro, she said.

Along with the National Institutes of Health, the FDA has already held 3 public workshops on preclinical issues surrounding pluripotent stem cells. A fourth workshop, addressing clinical considerations, will be held March 4, 2014.

The FDA has also issued 2 guidance documents on cell therapy products for industry, Dr. Wilson added.


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