Potential conflict on US stem cell treatment laws

 

A proposed stem cell treatment law in Texas could lead to conflict between the state and national regulator, the US Food and Drug Administration (FDA).

The FDA is concerned that some patients seeking cures and remedies are vulnerable to stem cell treatments that are illegal and potentially harmful. It is increasing its oversight and enforcement to protect people from dishonest and unscrupulous stem cell clinics, while continuing to encourage innovation so that the medical industry can properly harness the potential of stem cell products.

Stem cell-based cellular therapies are being actively developed and hold tremendous promise for treating a wide variety of medical conditions, from diabetes to heart disease and joint repair.  However, the use of stem cell-based products is new and characterising the product is challenging.

The FDA has the authority to regulate stem cell products in the US. Doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system. The only stem cell-based products that are FDA-approved for use in the US consist of blood-forming stem cells derived from cord blood.

The FDA is conducting research into identifying cell therapy product characteristics that will predict the reliably of the performance of cell-based therapies in humans.  In many cases, this is a challenge that is largely unresolved.

Americans go to Mexico for stem cell treatment that is not legal in the US. Many are Texans, so the state of Texas wants to encourage people to use locally approved clinics rather than seek unproven and untested treatment in Mexico.

The new Texas stem cell law has yet to go into effect; the state’s Health and Human Services Commission is still developing the procedures of how the law will be implemented.

The plan is for each stem cell treatment course to be reviewed by an independent review board and if accepted treatment could then be administered in one of the hundreds of medical institutions in Texas. A new law in California, which took effect in January, requires that direct-to-consumer stem cell clinics disclose to potential customers that the FDA does not approve their products.

If Texas does loosen regulations on unproven stem cell treatments, it will be in direct conflict with the FDA that has national control over every state.

View other news stories on the stem cell treatment sector.

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