FDA holds 2-day public hearing on stem cell regulation: 5 notes

Written by Jessica Kim Cohen | September 13, 2016 | Print  |

The FDA recently held a two-day public hearing, titled "Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products." At this hearing, the federal agency heard comments and feedback regarding its new draft guidelines on the regulation of stem cell treatments.

Here's what you need to know:


1. The FDA says it will consider feedback from the hearing — which included comments from physicians, researchers and other stakeholders — when finalizing its four draft guidance documents on stem cell treatments.


2. At present, stem cell therapies do not require FDA approval if the stem cells are derived from a patient's own cells; if the cells are not significantly altered; and if the cells are used in a similar role as their original function. However, some feel these guidelines need additional clarification.


3. While many scientists believe stem cell therapies will prove useful in the future, they emphasize that without additional research, stem cell clinics may be marketing dangerous procedures. Paul Knoepfler, PhD, told the Washington Post he is "worried that these are essentially experiments."


4. However, others oppose the argument that stem cell therapies should be more closely regulated. In March 2016, a group of senators led by U.S. Senator Mark Kirk (R-Ill.) introduced the REGROW Act, which would require the FDA to develop standards that expedite stem cell therapy approval — not slow it.


5. Orthopedic treatments are the most commonly marketed stem cell procedures, according to the Washington Post.


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