On May 31st of 2021, the FDA will finally bring clarity, hopefully, to the discipline of Regenerative Medicine by enforcing the rules and regulations initially announced in the fall of 2017. With said enforcement, I hope and pray that there will be a restoration of FDA oversite and elimination, or at least diminution, of the charlatans, camp followers, and prostitutes who have held themselves out to provide approved and regulated biologic interventions for an osteoarthritic joint without evidence-based scrutiny or appropriate training and credentialing.
Because of the promises inherent in stem cell therapies, opportunists took advantage by offering cures for arthritis and cartilage regeneration for “bone on bone” when in fact there was not a scientific chance of that happening. What we do know is orthobiologics will block pain in an inflamed joint for a period, that is still being studied and defined. What we also know is that orthobiologics will reverse the inflammation that generates pain in an arthritic joint leading to improved function and a lessening of symptoms. In a younger patient, there is a chance of cartilage regeneration and those chances decrease with age. What is not clear is the duration of effect of the several orthobiologic FDA-approved options. Some of my patients have experienced years of benefit and continue to improve years after the intervention. Our evidence-based outcomes surveillance and research suggest some patients who experience initial relief will report the return of discomfort in months or several years after an intervention. Only outcomes monitoring will help us finally determine the best approach for the needs of a particular patient.
As readers of this Blog are aware, I have been a co-investigator in several FDA monitored Stem Cell Trials to date and am presently involved in the planning of a third FDA Trial. While actively participating in the evolution of stem cell management of the arthritic joint, I have not lost sight of those I have treated who are either disappointed with an outcome or are experiencing a return of symptoms and limitations within 18 months of a biologic injection. If you fall into this latter category, call for a return visit as we have identified an updated solution that will minimize any out-of-pocket expenses outside your healthcare benefit plan.
To learn more about our Cellular Orthopedic practice, visit my website at www.sheinkopmd.com. For an office consultation, call (312) 475-1893. You may follow our progress with the FDA approval of the next Adipose Based Stem Cell Clinical Trial at www.personalizedstemcells.com.