A Texas stem cells showdown! Texas has a great history of going its own way. When I lived there as a Resident at Baylor College of Medicine in Houston, I’ll never forget that Texas is the only state where I have lived in that has a nationalistic pride, as if it were its own country. The Texas Medical Board’s recent decision on stem cells supports that thesis.
The controversy started in Texas over Stan Jones, M.D., a hard working and diligent orthopedic spine surgeon with his own medical condition. Stan received treatment in Japan with his own cultured stem cells which were injected IV. After a miraculous improvement in his wide spread pain due to a rare muscle disorder and seeing some of the great results a South Korean company had produced, he licensed their fat stem cell culture technology and brought it to Texas.
Dr. Jones’ procedure involves culturing fat derived stem cells for a few weeks to get more cells and then either injecting them intravenously or placing them in a surgical site. The procedure was first tried on Texas Governor Rick Perry to assist Perry’s back fusion (the cells were placed into the fusion mass to promote bone growth). While Perry didn’t make it to the finish line as a presidential candidate, his stem cell treatment cued up the next big test of the FDA’s “cells=drugs” policy.
What makes this such a big, brewing battle is that this month the Texas Medical Board (TMB) weighed in with new rules that are favorable to physicians using stem cells, balancing potential risk without stifling physician innovation. The TMB ‘s new rules will allow a doctor to use stem cells as the practice of medicine as long as the patient knows that the treatment isn’t FDA approved and the doctor gets approval and monitoring from an Institutional Review Board (IRB). This approach makes sense to us, as we’ve always used IRB’s to review and check on the safety of our stem cell therapies. The approach also allows for an additional patient safety net in a new therapy without supporting the FDA’s “cells=drugs” policy. These rules also set up a Texas size brawl in the area of state vs. federal control of medicine.
The battle royal that’s about to happen will be epic…Texas vs. the FDA. The upshot? This is the next big test of “your cells=drugs”. Expect Texas size fireworks…