Cellular Orthopedics Blog
Cellular Orthopedic International Diplomacy
Three and a half years ago, I performed a Bone Marrow Concentrate for the arthritic hip of a visiting orthopedic surgeon, who had sought me out so as to help him postpone, perhaps avoid a joint replacement. Given professional discretion, I am unable to disclose...
Reporting as Your Regenerative Medicine Town Crier
Last week, I received an update from Personalized Stem Cells, Inc. indicating that the trial submission to the FDA concerning a third Adipose-Derived Mesenchymal Stem Cell Study for the arthritic knee would take place in late September or early October. You may learn...
Should You Repeat a Biologic Application?
As we continue to monitor outcomes from the thousands of patients treated in our offices over the last ten years, the evidence we gather tells us that outcomes improve with repeated biologic injections. We also note that outcome improvement varies, so some patients...
On Stem Cells, Biologics, Growth Factors and their Influence on Joint Structure and Function at Five Years
During the course of my office day on Tuesday, two patients happened to return for follow-up, both five years after having undergone Bone Marrow Concentrate and Growth Factor Concentrate interventions to arthritic knees. While two patients are not statistically...
“Don’t let the old man in”
Over the weekends this spring and summer, I have ridden my bike with other cyclists on group rides in the Driftless area of Southwest Wisconsin. The rides may last as long as three hours and cover distances ranging between 20 to 30 miles, up and down. The groups are...
On Biologics, Structural Repair of Arthritic Joint Defects, Supplements and Exercise
In my last blog, I introduced the possibility of repairing structural cartilage defects and supporting bone defects in an arthritic joint by the application of Collagen. While supplementing orally, with collagen peptides is one of the most popular attempts...
On Structural and Cellular Repair of Articular Defects
Under Section 361 of the Public Health Service Act, biologic products must meet the following four criteria: they are minimally manipulated; they are intended for homologous use; they do not involve a combination of cells and tissues with another article (with some...
Regenerative Medicine and Stem Cells, What’s Next?
On May 31st, the FDA made it clear, that it would crack down on the charlatans, the prostitutes, and the camp followers who both fail to follow the FDA guidelines for Regenerative Medicine offerings and put the patient at potential risk. While, I am still able to use...
Protocols for Evaluating Stem Cells and Growth Factors in Orthopedics
In addition to the usual and customary clinical outcome parameters currently in use, my research initiative also emphasizes a responsible approach; incentivizing patient reporting of long-term outcomes. ~ Mitchell Sheinkop, M.D. The prospect of stem cell and growth...
Regenerative Medicine Reflections
By an Evidence-Based Cellular Orthopedic Surgeon Memorial Day has come and gone. On May 31, the FDA finally started enforcing many of its rules; and Amniotic Fluid, for the time being, is no longer considered FDA compliant. Gone too are all the other biologic...
Memorial Day and Regenerative Medicine
By an Evidence-Based Cellular Orthopedic Surgeon The Food and Drug Administration has pledged that after May 31, 2021, the agency will broadly enforce requirements that developers of regenerative medicine products — therapies intended to repair or replace damaged...
Cellular Orthopedics for Osteoarthritis
From Upcoming Treatments to Treatments Yet to Come On Saturday, I graduate into yet another decade of my life’s journey. In this Blog, instead of looking back, I will look to the future. The U.S. Food and Drug Administration plays a vital role in facilitating the...