In 1931, Swiss doctor Paul Niehans injected a preparation of live cells from a parathyroid gland into a dying patient. The patient subsequently recovered, and Dr. Niehans had a eureka moment — that injections of living cells can have tremendous therapeutic value.
Today, there are 13 FDA-approved cellular therapies on the market and over 10,000 clinical trials open for cell therapies. (By comparison, there are approximately 3,000 trials are open for antibodies.) Additionally, the FDA just this month created the new Regenerative Advanced Therapy designation to expedite the development and review of cell therapies for serious or life-threatening conditions. The small number of approved products, large number of trials, and favorable regulatory climate raise the odds of a large gap in manufacturing capacity occurring in the not-so-distant future.