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Are the stem cells in your body drugs or body parts?

I’ve been discussing stem cell research with folks recently and although we do have disagreements on the ethical use of some stem cells, the consensus agreement that stem cell research can be a useful tool in fighting and treating disease and bettering medicine for the future.

But here’s some interesting news:

Two Colorado doctors who use the patient’s own stem cells to prevent the need for more invasive orthopedic surgery are fighting city hall by challenging the FDA to determine if the stem cells in your body are drugs or body parts. The outcome of their case will determine if your local doctor will have to wait 20 years to treat your medical problem with your own stem cells or can start treating patients tomorrow. Medicine will be forever changed if they are successful. Since these are stem cells from the patient, this procedure avoids all the ethical issues of embryonic stem cells.

Dr’s Centeno and Schultz issued this press release about Regenerative and the FDA and this fight over whether or not stem cells can be regulated just as regular drugs. Already we know that in the United States, FDA-regulated drugs can take decades before they become affordable to the ones who need them most, as pharmaceutical companies fight to extend the patents on these drugs for as long as they can.

As it stands, the FDA believes your stem cells are considered drugs. The Colorado doctors who are challenging the FDA with this lawsuit have sued the FDA four times.

Drs. Centeno and Schultz claim to use high standards in their cell lab as defined by the International Cellular Medicine Society (see, but have refused to use drug factory guidelines, as they claim they do not produce drugs.

Centeno and Schultz have published numerous scientific papers showing that their stem cell based procedure is safe and effective, see (see In particular, in one yet-to-be-published study, only four percent of patients who were likely to need a knee replacement ended up getting it after they had their own stem cells injected into their knees.

Centeno and Schultz are still offering a same day stem cell procedure that the FDA doesn’t take issue with; the dispute is over cultured stem cells. Their argument is that until they fight the FDA and win, they have stopped using cultured stem cells.

So read this press release and ask yourself: Are your stem cells considered a body part or a drug? Do you have to wait to use your own stem cells 20 years from now, or can you be treated with them tomorrow? It’s a very thought-provoking topic and sure is making me question ethics in medicine.

To learn more about how patients can still avoid the need for invasive orthopedic surgery, see Regenexx SD link.

This is a Sponsored post for Regenexx. All unattributed opinions are 100% mine.

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