Clinical Uses
Regenerative medicine is a rapidly growing field that has gained significant attention because it can change healthcare by providing new treatments and solutions for conditions that were once thought to be incurable. This field is expanding into many areas of medicine, thanks to new technologies, a better understanding of how our bodies work, and the need for more advanced treatments. Doctors are now using regenerative medicine to help patients heal faster, repair damaged tissues, and even create new organs. It’s being used in everything from heart disease and joint injuries to skin repair and organ transplants, making it a key part of modern healthcare.
It’s important to understand that most uses of regenerative medicine today remain in an experimental phase. Some specific regenerative medicine treatments have been approved by the FDA. This includes the use of blood-based stem cells cells for specific disorders such as blood-based cancers and some select gene-therapy products.
Click on this link to see what types of treatments are approved and are NOT approved by the FDA. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies.
In addition, there are thousands of clinical trials are looking into stem cell therapies for various organs like the heart, lungs, kidneys, and liver. These trials are important to find out if these treatments are safe and effective. In eye care, over 200 trials are exploring how regenerative medicine can help with conditions like macular degeneration and retinitis pigmentosa. Go to this link to search for clinical trials in regenerative medicine that are ongoing; https://clinicaltrials.gov/search?term=regenerative%20medicine
Unapproved Clinical Uses
There is a startling rise of clinics across the U.S. offering unproven and unapproved regenerative medicine therapies for various conditions like aging, arthritis, COVID 19 complications and even autism. These clinics make claims that lack solid scientific evidence. The safety and effectiveness of many regenerative medicine products outside a few approved uses are still not proven.
These clinics use products from people’s own bone marrow or fat, as well as tissues like placenta or cord blood from donors. Although some may believe these products are safe, they can actually be dangerous, especially if they aren’t made following proper guidelines. In fact, there have been serious cases where people got infections or other complications, such as blindness, after receiving unapproved stem cell treatments. Because of the growing number of harmful events linked to these therapies, the FDA has been taking steps to stop clinics from using them.
The vast majority of these unapproved therapies are being used without FDA approval, which is concerning because they haven’t been fully tested for safety or effectiveness. Some companies wrongly claim that their products don’t need FDA approval, but they do. Without proper oversight, it’s hard to know how many people have been harmed by these treatments.
The FDA has acted by warning companies and even seizing dangerous products, but they need help from doctors and patients to find and stop these unsafe practices. Patients should ask their doctors if a treatment is FDA-approved or if it’s part of an official clinical trial before considering it. They should also be informed that they shouldn’t have to pay for experimental treatments unless the FDA allows cost recovery for research purposes.
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