Health News

FDA Releases Guidelines On Stem-Cell Treatments

Photo from Wikipedia

The US Food and Drug Administration finally announced its guidelines on stem-cell therapies on Thursday, meant to clear up the confusion on which treatments are going to be designated safe and appropriate, and which therapies have the most risks and most benefits.

The guidelines have been carefully worded to emphasize the limited space regulators have between allowing approvals of what could be life-changing cellular therapies and preventing manufacturers from marketing unproven stem-cell products straight to patients.

Scott Gottlieb, FDA Commissioner, said in a statement, “The promise of this technology is why the FDA is so committed to encouraging and supporting innovation in this field,” The San Francisco Gate reports.

But the rapid growth and promise of this field has increasingly sowed the ground for the entry of some unscrupulous actors.

FDA officials said that they would enforce stricter measures on stem-cell clinics that offer potentially dangerous therapies, many of which cost thousands of dollars, to patients who have life-threatening conditions. These clinics have been flourishing in the United States for many years now, with federal regulators leaving them alone for the most part.

The agency has been under pressure from scientists and consumers to clarify its guidelines on stem-cell treatments, which use cell therapies to repair body parts that have been damaged by injuries and illnesses.

Scientists have been arguing that traditional avenues of approval for other kinds of treatments should not apply to cell-based therapies, as the old processes hinder research and make it time-consuming.

Stem cell experts have cried foul over the proliferation of consumer clinics that advertise being able to treat all manners of conditions, from brain diseases to sclerosis.

The procedure was in the spotlight in March when news of three women who were blinded by stem-cell treatments made national headlines.

FDA officials have said that they intend to prioritize enforcement of guidelines at clinics that offer the most dubious stem-cell therapies. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “We’re not going to turn a blind eye to a manufacturer of stem cells for injections into the knee who might be making contaminated cells that put people at risk.”

Click to comment
To Top

Hi - We Would Love To Keep In Touch

If you liked this article then please consider joing our mailing list to receive the latest news, updates and opportunities from our team.

We don't want an impostor using your email address so please look for an email from us and click the link to confirm your email address.