We don't often hear of tragedies being turned into gifts but this describes Ted Harada's case who was diagnosed with ALS, also known as Lou Gehrig's disease. After receiving stem cells, Harada's condition significantly improved regaining strength in both his hands and legs. At first the researchers at Emory University believed he was having the "placebo effect" but later tests showed, to their surprise, a phenomenal improvement.
Did Harada's case help with the approval of the stem cell therapy with the FDA?
Yes, the results of the phase I trial persuaded the FDA to give a green light to Neuralstem for phase II (Feb, 2013) and the company also received orphan designation for its ALS candidate. The positive clinical progress of the therapy encouraged researchers to keep going with their studies even with the remaining obstacles they may have to hurdle.
What progress has the industry made since Ted Harada's miracle?
Two researchers, Gordon Mitchell and Clive Svendson led a team that conducted a large study at the University of Wisconsin Madison that involved the potential of two complimentary treatments for ALS. The potential treatments have slowed down the rates at which cells die and helped preserve the breathing function. This is a major advancement in finding a treatment for ALS which currently still has no cure, and can be seen as a consequence of the current discussions between patients, industry and regulators.
Join us at the Stem Cells & Regenerative Medicine Congress this fall to find out more about next generation approaches in the stem cell industry.