Ryoncil: ODAC/FDA Meeting Discussion, page-164

Wilson Bryan – Opening Speaker

Stressed importance of this hearing as the treatment is for “highly vulnerable patients, they are vulnerable because they have a life threatening disease, they are vulnerable because as children they cannot fully participate or give informed consent for decisions regarding their medical care.”

“These patients and their vulnerability should stay in mind”

“The FDA is concerned that a wide variety of MSC products are being marketed and sold illegally in the United States to treat those conditions

These products have not been shown to be safe and effective but are marketed to vulnerable and desperate patients who are often charged thousands of dollars.”

“If stem cells receive marketing approval it is critical that every pediatric patient receives the product that has the same safety and effectiveness as seen in the clinical trial or trials that supported that marketing approval.”


Thought I would post my notes as the meeting continues for those that can't tune in.