The Food and Drug Administration has issued new guidelines on Nov. 16 for the development and oversight of regenerative medicine products, including stem cell therapies.
FDA has also said it would crack down on the rogue and unauthorized clinics, which offer unproven or dangerous versions of regenerative treatments that have quickly escalated into a flourishing industry globally.
New Guidelines For Regenerative Therapies
FDA Commissioner Scott Gottlieb stated that the use of regenerative medicine products is no longer science-fiction stuff. Humans have reached a juncture of paradigm change in medicine, which shows promise of regenerating parts of the human body.
The advancements in the science and medical fields indicate that diseases can be combatted by introducing new genes into the body, tissues and cells can be engineered for healthy growth, diseased organs can be replaced with functional ones, and adult stem cells can produce replacements for cells that are lost to disease or injury.
Gottlieb, however, said that malpractices exist, and certain regenerative products that are harmful to people are also marketed. The FDA, therefore, has announced a policy framework that will protect patients from the risky products while making it faster to access new safe and effective therapies.
“With the policy framework the FDA is announcing today, we’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities,” the commissioner said.
A Check On Rogue Clinics
Questionable and rogue stem-cell clinics have mushroomed all over the United States, which offer treatment for everything, from heart disease to sore knees, even as the field has advanced in the past few years.
“With high price tags, so-called 'stem-cell' clinics are designing therapies without evidence that serve to do harm, be ineffective, prey on the most vulnerable — potentially curtailing their ultimate treatment choices, and threaten the legitimate work being done that holds great promise for devastating disease,” according to a report in the American Council on Science and Health.
FDA's announcements included two final guidelines and two drafts created to enable developers to understand whether they need to submit a licensing application to the agency approval or fall into a lower-risk category that does not need premarket approval.
The steps mentioned in the guidelines and drafts will put a check on the rogue clinics that treat ailments by liposuctioning belly fat from patients and subsequently process it to get the so-called stem cells, which are then injected back into the patient. Unregulated procedures such as these have been offered for heart disease, back pain, arthritic knees, and other problems.
At the same time, one of the proposals in the guidelines will permit small clinics and independent researchers to apply as a group and pool data, which will serve as a boon for them. If approved, each would end up with a license for biologics, referring to treatments such as gene, tissue, and cell therapies, which are produced from natural sources instead of being chemically synthesized.