Doctors Treating Patients With Their Own Stem Cells

Progress in medicine is heavily dependent on research, especially well designed and executed clinical studies, and also to discoveries and innovations made by doctors using FDA approved drugs and therapies (and in some instances supplements, e.g., herbs, vitamins, amino acids, etc.) in novel ways and combinations in treating patients ("In-office tinkering" or experimentation, one might say). So long as what a doctor is using does not constitute a "new drug" by FDA criteria and does not violate agency rules that govern new devices or such, what the doctor is doing is considered the practice of medicine and is governed solely by his or her state medical board.

If a doctor were to treat ulcer patients using a combination of an approved drug such as cimetidine (Tagamet) and an herbal ulcer product such deglycyrrhizinated (DGL) licorice, this would fall under the practice of medicine and represent a form of low risk medical experimentation that most state medical boards allow provided informed consent requirements have been met, i.e., the patient has been told about known and suspected risks, side effects, or complications (Higher risk forms of experimentation might require the treatment regimen or protocol be approval by an Investigational Review Board aka as an ethical review board). If this particular combination happened to heal up ulcers better and surer than the drug alone then this would represent an innovation of the sort that propels medicine forward. If on-the-other-hand a doctor wanted to try a drug for advanced cancer approved in the EU but not in the US, he would have to comply with FDA rules and procedures concerning new drugs. He might, for instance, get be able to get permission to use the drug by filing an emergency IND (Investigational New Drug) application and having this reviewed by FDA officials. If they felt the risk v. benefits favored use in this instance, they would grant the doctor a new drug (IND) permit for the one-time use of the anticancer drug in question.

But what if a doctor wanted to use stem cells from a patient's own body to treat his arthritic knees and bad back? Given the fact there is no risk of rejection, would the FDA take issue with a doctor taking a patient's own fat or bone marrow stem cells and treating his bad knees and back?

The answer depends on what is done with the stem cells and how they are administered.

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