Stem Cell Treatments in the US

Not many treatments are FDA approved

The status of FDA or other regulatory agency regarding stem cell treatments is foggy with many providers operating in a "grey area". Before opting to send patients to the US for treatment or receiving treatment yourself, here is what you need to know - information that is often omitted or blurred.

According to Dr. Louis Cona, medical director of the Advanced Stem Cell Therapy Center in Cayman, "In the United States, the FDA has issued guidance on the appropriate use of stem cells in clinical trials and has established a regulatory framework for developing and testing stem cell products. However, to date, the FDA has not approved any stem cell products for general use within the United States and has cautioned consumers against seeking treatment at stem cell clinics in the US.

In the United States, many stem cell clinics operate in a legal gray area, as the FDA has not approved many treatments. While the FDA has issued guidance concerning the use of stem cells in clinical trials, it has not approved any stem cell products for general use. This means stem cell treatments cannot legally be marketed or sold to the general public, although some clinics may still offer them."

Seeking treatment abroad

Because certain treatments are not available in the United States, patients look at other countries where stem cell treatments may or may not be regulated. A variety of such treatments are offered around the world. Some are safe and effective, others are fake, taking advantage of patients who may be desperate for a cure.

Stem cell treatments are regulated for certain types of treatments in certain destinations including Costa Rica and Panama. Stem cell therapies became legal in Costa Rica in 2016 and may be offered provided certain legal requirements are met. Read more about these restrictions here.

The US Library of Congress issued a report on the status of stem cell regulation in Argentina, Brazil, Chile, Costa Rica, El Salvador, Mexico, and Panama. Access the full report here.

Do your research!

What does all of this mean for patients receiving stem cell treatments in the US or traveling abroad?

1. Find out if the treatment is legal in the destination where it is offered.
2. Understand the potential side effects and risks associated with each procedure.
3. Ask questions including what happens if there are untoward side effects.
4. Unscrupulous individuals offer untested, ineffective, or experimental stem cell procedures. Don't fall prey to their schemes! Do your research and consult your doctor to make sure the treatment you want is safe and effective.
5. If the marketing messages seem too good to be true, keep looking for better answers and safer services.