A new way of licensing adult stem cell clinics should be considered. Actually at this time, there is no licensing pathway. And why? Because in what would appear to be a power grab, the United States Food and Drug Administration (FDA) has declared living cells in our bodies to be “drugs”.
How is a living cell that breathes oxygen, “talks” to adjoining cells via messenger molecules, reproduces itself and eventually dies a “drug”. Only in America…
The FDA has no jurisdiction over the stem cells in my body, and if i want to collect them from my abdomen, concentrate them and put them somewhere else, this is a Medical Procedure between me and my physician, not anything about drugs. A Medical Procedure. Same as when an immunologist injects a patient with mold, cat hair, pollen, house dust and other material in a a process called allergy shots. Is the mold, dirt, cat hair and other foreign substances that the immunologist injects into a patient regulated by the FDA? No. Why? Because these are medical procedures under the control of the physician even though unnatural, foreign materials are injected into a patient. Does every immunologist use the same ingredients? No. Each physician may collect different molds, dirt, cat hair and so forth from the individual patient’s surroundings. Yet, the use of these unregulated injectable substances is permitted by the FDA.
Should Embryonic stem cell preparations be regulated? For sure, because they always cause tumors or are immediately recognized as foreign to the patient’s body and are rejected. The hope and purpose in creating embryonic stem cell preparations is that a physician can use a patented off the shelf product to treat some condition. We say “hope”, because after over 20 years of study there has yet to be one single preparation created that can treat a disease or condition.
Compared to Adult Stem Cell therapy, which has been treating patients’ diseases and conditions successfully for over 20 years worldwide.
It is time for American politicians and people in power to wake up and get serious about exploring this new medical modality.
Adult Stem Cell therapy should be regulated by State Medical Boards, just like outpatient surgery centers are. Therapy using adult stem cells is so much closer to outpatient general surgery than it is to dispensing a “drug”.
No national regulation is required provided the States take control. But as long as the FDA sits there like a big elephant on the railroad tracks, nothing moves forward and the American people are deprived of this great new medical advance that our best scientists and practitoners should be developing.
Thailand recognized that their FDA, which essentially is the same as ours, was not the appropriate regulator for stem cell medical procedures. Stem Cell Treatment centers in Thailand are regulated and licensed by a special Medical Board composed of practicing physicians who decide about proper procedures and handling of a patient’s stem cell collected from blood, bone marrow, or fatty tissue.
It’s a good example to follow. And even though Thailand offers a robust stem cell health care, there has yet to be any complaint or bad result from adult stem cell transplants using the patient’s own stem cells since their special Medical Board was created about 12 years ago.
This is what the US should implement.
We say again, the treatment of patients with adult stem cells is closer to an outpatient surgery procedure than to the dispensing of drugs.