Putting aside the embryonic stem cell debate, there have been amazing advances in adult stem cell research. For example, scientists have been able to transform skin cells into stem cells and then grow heart cells in a petri dish.
“What is new and exciting about our research is that we have shown that it’s possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are healthy and young – the equivalent to the stage of his heart cells when he was just born,” the study’s author Professor Lior Gepstein, professor of cardiology and physiology at the Technion-Israel Institute of Technology in Haifa, said
Don’t start making really, really long term plans for your eternal life. It is also possible the cells could develop into tumors. Lots more research to be done…if the FDA doesn’t stand in the way.
One treatment that is working successfully today is a procedure developed by Regenerative Sciences. Physicians take some blood and bone marrow from a patient, culture stem cells in the laboratory and then inject them back into the patient. The procedure treats joint, muscle and bone pain. That is your own blood and your own bone marrow cultured into stem cells and injected into your own body. The FDA says those stem cells are a drug and subject to FDA regulation. The counter argument is that the procedure is considered the practice of medicine.
Regenerative Sciences went to court and lost.
The Court ultimately sided with FDA, although it called the decision a “close question.” Among other things, the Court found that the Regenexx Procedure is a drug as defined under the FDCA as it determined the procedure is an article intended to treat a condition (i.e., orthopedic pain).
The Interstate Commerce clause reared its ugly head in this too.
It should be noted that the Court only found that the Regenexx Procedure was introduced into interstate commerce because a component used in the procedure moved through interstate commerce. …We noted that such an interpretation of the interstate commerce requirement was highly unusual to say the least and would significantly expand FDA’s authority. It is interesting that the Court’s opinion did not even mention that constitutional argument.
The U.S. District Court for the District of Columbia claims the procedure is an adulterated and misbranded drug.
Following the interstate commerce ruling, the Court ruled that the Regenexx Procedure is an adulterated and misbranded drug. It is adulterated because it is not “manufactured” in conformance with cGMP requirements and misbranded because the information on the “label” on the syringe that contained the processed stem cells did not include the statutory or regulatory disclosure requirements. The Court also ruled that FDA is not interfering with the practice of medicine by regulating the Regenexx Procedure because FDA is merely attempting to control the availability of a “drug” rather than controlling which approved drug a physician uses.
Regenerative Sciences vows to appeal. The implications of the FDA’s claims and the court ruling are massive. Stem cell therapy is a nascent science. Pioneers in the field will be hindered by regulations yet to be determined. The FDA requires clinical trials for drugs. How do you perform clinical trials for one patient’s therapy? What are the implications for in vitro fertilization, a similar procedure? How about blood transfusions using your own blood for surgery?
I guess the idea is for the government to get in early and assert authority. In the meantime other countries are making significant progress.
We don’t want a bunch of mad scientists brewing up brave new world cocktails willy-nilly, but I think there are other ways to protect patients without damaging this country’s opportunities for revolutionary breakthroughs in the practice of medicine. When it comes to adult stem cell research, it is an out of control FDA that is the most feared malignant growth.