Joy Kong, MDRegenerative Medicine Physician, Educator, and Entrepreneur

Your Doctor May Be Breaking the Law With Your Stem Cells

7 Apr 2026 · 1 min

Watch on YouTube

0:32

In this excerpt, Dr. Joy Kong explains the regulatory distinction between expanded (manipulated) stem cells and native (unmanipulated) cells in the United States. She states that the FDA requires any use of expanded cells to be conducted within a clinical study; administering such cells outside a study is unlawful. By contrast, her clinic uses native cells, which are classified as tissue transplants—similar to organ transplants or blood transfusions—and therefore do not require FDA drug approval, falling under the practice of medicine. She highlights that many companies offering expanded cell therapies may be operating outside legal bounds, while her approach remains compliant.

Chapters

There are a lot of companies who are using expanded cells in the United States. If your doctor's giving you expanded cells, it's supposed to be under a clinical study. So if it's not, then that's not really lawful because you can't manipulate the cells and then give it to patients without having enrolled the patient in a clinical study. So that's a rule from the FDA. But in our clinic, we use native cells. So that's considered a tissue transplant. We're not using a drug. We're using a tissue transplant, just like liver transplant, blood transfusion, right? From one person to another, you don't need an FDA approval. The practice of medicine.