FDA indicates some of stem cell treatments need regulation

FDA indicates some of stem cell treatments need regulation

The US Food and Drug Administration (FDA) now believes that some of the stem cell treatments need to be regulated as drugs therefore, they would require advance approval. The matter has resulted into a serious debate among patients, politicians and physicians.

On Monday, the federal agency has started a two-day hearing process on draft guidelines to clear what it thinks on stem cell treatments. The guidelines have resulted into severe criticism in the stem cell industry, as it might bring closure of many of the clinics’ operations.

Paul Knoepfler, a stem-cell researcher at the University of California at Davis, said that it is been quite late for the authorities concerned, which has remained on the side and patients were charged thousands of dollars for unapproved treatments. It is good if the FDA is taking steps, mentioned Knoepfler.

But there are patients who have been benefitted from the treatment and do not want the FDA to clamp down. Stem cell therapies need to be tested in clinical trials and approved by the FDA before they are offered to patients. But in the case of stem cells that have not been changed much do not require the approval.

Some Republican senators, including Mark Kirk of Illinois, want to bring changes in the FDA approval process to speed up stem cell therapies. Scientists swear by stem cells’ ability to develop into different kinds of cells meaning that someday it would be used to repair diseases or damaged cells.

Stem cell therapy has witnessed a great expansion in the US. It can be known by the fact that five years ago, only a few clinics were there, but the industry has spread a lot.



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