Understanding the Regulations Around Stem Cell Treatment

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by Wendy Henderson |

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Stems cells are increasingly being considered as a treatment option for a myriad of diseases, so it’s important to understand how they are regulated in the U.S.

MORE: The different types of stem cells.

Stem cells, like other treatments, are regulated by the Food and Drug Administration (FDA). To date, the FDA has only approved the use of hematopoietic progenitor cells (HPC). These cells are derived from donated umbilical cord blood, which is then used to treat patients with diseases that affect the body’s blood-forming system.

In order to reduce the risk of spreading disease from donor to recipient, all manufacturing of stem cell products must undergo stringent production and administration reviews, along with an analysis of whether they’re safe and effective.

Proposed guidelines for future approvals say that donated tissue and cells must only be used in the area of the body they have originally been donated from. For instance, skin tissue can only be used to promote new growth of skin tissue in the recipient.

The FDA is concerned that patients with potentially life-threatening diseases will see stem-cell therapy as a cure-all solution when this has not yet been proven and that cells or tissue implanted into recipients may move or change into different cells than originally intended, thus creating more health problems for the patient.

For people thinking of traveling outside of the U.S. to receive stem cell treatment, the FDA advises extreme caution and that patients fully understand the regulations in the country they plan to travel to. Find out more about stem cell regulation here. 

MORE: Stem cells and scleroderma.

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