Doctors hope the new rules will make it easier for the FDA to crack down on malicious stem cell providers

The Food and Drug Administration (FDA), long considered tomorrow’s drug, describes stem cell therapy on its website as “it may offer the potential to treat diseases and conditions for which there are few cures.” I will.

But after years of misleading claims by several clinics promising illnesses and unproven, and often unregulated treatments, the FDA’s grace period has expired and stem cell exaggeration. It’s now easier for the federal government to identify dubious clinics and manufacturers who are trying to take advantage of advertising.

“Stem cell therapy and regenerative medicine work, but they’re actually amazing,” said Dr. Robert Dean of Tampa’s Advanced Regenerative Orthopedic Surgery. He offers stem cell therapy in combination with nerve resection. Dean is currently registered with the FDA and sells his treatment as an “investigative drug” or IND.

The application period for IND began in 2017 and ended on May 31st of this year. This allows the FDA to track who is offering stem cell therapy, what it sells, and to whom it sells it.

Dean believes that this type of tracking will help wipe out as many deceptive industries as promised. In 2018, we went secretly to introduce the suspicious claims made by some providers about the use and efficacy of stem cell therapy, many of which are unapproved and unproven.

By the summer of 2019, the industry had been hit as a result of bad news and a wave of talk that highlighted the dangerous consequences that some patients experienced after stem cell therapy, Dean said.

“People were much more critical of the supposed practitioners trying to sell them,” Dean said.

According to the FDA, since 2018, the FDA has issued at least 400 warning letters to stem cell manufacturers and clinics that may offer illegal products. Since November 2017, the agency has filed two injunctions. One of them asked US Stem Cell Inc, a stem cell clinic based in Broward County, Florida, after several patients had lost their eyesight after treatment.

Dr. Zubin Master, a Mayo Clinic bioethicist focused on regenerative medicine, believes the FDA has done a good job of regulating the industry, but more if the stem cell industry is globally standardized. I believe I can do it. He recently co-authored a report calling for participation in the World Health Organization (WHO). Aside from his role at the Mayo Clinic, the Master, who wrote this report, better regulated industries around the world by setting more global standards for stem cell therapy, and approved usage and approval for stem cell therapy. We believe it will help dispel false information about unsuccessful usage.

“Is there a way to sympathize with the patient’s struggle in this area and not only fight false information in a sympathetic way, but also warn of the risk of receiving unproven or unregulated stem cell therapy?” Little work has been done in the field, “said the Master.

A spokesperson for the FDA said in a statement: “We are committed to continuing to take action against those who sell unapproved stem cells or related products in violation of federal law as our compliance and enforcement policies have ended. We are also committed to benefiting individuals in need, working with people who share the goal of promoting the development of safe and effective regenerative medicine products, including. “

Doctors hope the new rules will make it easier for the FDA to crack down on malicious stem cell providers

Source link Doctors hope the new rules will make it easier for the FDA to crack down on malicious stem cell providers

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