FDA 2-day hearing on their stem cell treatment guidelines

stem cell treatment guidelines
FDA considers its options on the regulation of Stem Cell Therapy

Stem cell therapy’s popularity has increased immensely over the past several years after federal officials loosened their restrictions on the practice. But as we mentioned in a past post, “Stem cell therapy gaining more attention as popularity booms,” this sudden surge in recognition has led some critics to speculate whether the industry now has too much freedom.

And too much of anything can be a bad thing.

“To date, regulators such as the FDA have not taken significant action on stem cell clinics in the United States, and it is not clear why,” said Paul Knoepfler, professor of cell biology and human anatomy at the University of California Davis School of Medicine. “As a result, the clinics and those considering opening new clinics view the lack of action as a green light for them to proceed.”

“It’s crucial professionals comply with federal and state regulations and adhere to general practice guidelines.”

While at first it may surprise you a stem cell therapy provider would be skeptical about regulations, you shouldn’t be. We, at Longevity & Stem Cell Centre, believe it’s crucial those in the field comply with federal and state regulations as well as adhere to general practice guidelines. This ensures patients are safe.

Dr. Arthur Caplan, a professor and founding head of the division of bioethics at New York University Langone Medical Center said there’s great interest in using stem cells to treat serious conditions.

“There are a lot of people interested in using stem cells to try to repair orthopedic problems, shooting them in the joints in the knees to try and regrow bone and cartilage. That’s been around for a while. There are lots of folks trying to use stem cells in more research settings to regrow spinal cord; there are clinical trials going on of that,” said Dr. Caplan, according to CNN.

While the future is bright, it’s critical the practice is regulated in the correct way – emphasis on the word “correct” to prevent faulty practices or treatment from taking place.

The FDA acts on regulation guidelines

In 2014 and 2015 the Federal Drug Administration developed a series of guidelines that would offer or require great transparency between provider and patient. The FDA just recently held a 2-day event in September to discuss the guidelines and finalize the proposal.

“The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public,” noted the FDA in a statement.

When you work with Longevity & Stem Cell Centre, our goal is to provide you with as much as information as possible to ensure you feel comfortable with your scheduled procedure. Transparency is key, and we take great pride in providing advanced treatments that follow current regulations, guidelines and industry-best practices.

“People have the right to decide what happens in terms of the tissues and cells from their own bodies,” said Doug Oliver, a resident of Nashville who has a rare eye disease, according to Laurie McGinley of The Washington Post. McGinley reported that after Oliver received stem cell treatments in his eyes he was able to drive again.

We must also note its important patients and providers ask questions or address concerns prior to undergoing stem cell treatment. This level of transparency will ensure procedures go smoothly.