Scott Gottlieb’s FDA has implemented many policies in recent years that look to fast-track certain kinds of regenerative medicine procedures so that said procedures can get to market faster. One example of this fast tracking is a procedure for treating rotator cuff injuries that the FDA recently confirmed as being safe.
The treatment itself will be explained in just a moment. First though, it is important to discuss why the FDA’s acknowledgment is important. Being confirmed as safe does not necessarily mean the procedure is efficacious. It does mean that patients are not at any measurable risk of complication or rejection as a result of undergoing the procedure.
Furthermore, the researchers behind the project sought FDA confirmation because the procedure falls outside current FDA regulations governing minimally manipulated autologous material used in regenerative medicine procedures. The fact that the procedure has proven safe means that doctors can proceed to the second stage of their study in hopes of gaining FDA approval for marketing the procedure.
About the Procedure
As for the procedure itself, it involves utilizing stem cells harvested from the patient being treated. As such, the stem cells are considered autologous. Doctors extract adipose fat tissue from the patient’s belly using liposuction. The fat is then treated with an enzyme to concentrate what are known as adipose-derived regenerative cells.
Those cells are injected into the site of injury in order to help promote repair of a partially torn rotator cuff. How well it works will be determined by the next phase of study. Researchers will look at 200 patients to measure the efficacy of the treatment. So far though, things look promising. The phase 1 study involved 18 patients.
One of the treated patients said that the procedure facilitated regrowth of a damaged tendon. Other patients reported increased range of motion and reduced pain. Researchers say that the injections reduced inflammation across the board.
Autologous Material Is the Key
Here at the Advanced Regenerative Medicine Institute, the procedures we teach all involve autologous material. Whether it’s PRP or stem cell therapy, the material doctors inject into the site of injury comes directly from the patients being treated. We cannot emphasize this enough.
While stem cells hold a lot of promise for treating everything from cancer to Parkinson’s disease, there is still only one procedure utilizing non-autologous material approved by the FDA: the bone marrow transplant procedure used to treat leukemia patients.
The fact is that we do not yet know whether stem cells harvested from complete strangers or grown in the lab can do what we think they can. We do know that autologous stem cells can do some pretty amazing things on their own. We also know that, by their very nature, they can be safely used to treat musculoskeletal injuries, diseases like arthritis, and even hair loss.
Sign up for Your Training
Hopefully the news of the rotator cuff study has encouraged you to learn a bit more about regenerative medicine. If so, we invite you to consider signing up for one of our training sessions. We train doctors to utilize PRP and stem cell therapies for both physical and aesthetic applications.
We believe in the potential of regenerative medicine to help countless numbers of patients looking to avoid things like surgery and steroid injections. We have seen firsthand how harvesting autologous stem cells and injecting them in the right locations can make a real difference in the patient’s life. You can begin offering the procedures in your own practice by completing your training at the Advanced Regenerative Medicine Institute.