• The U.S. FDA regulation of cell therapies finally is enforced

    “Mitch, not sure if you heard, but the FDA via the DOJ has requested injunctions against the mothership clinics of Berman and Lander, as well as the US Stem Cell clinic run by Comella. We can hope that criminal indictments might follow, since they certainly are some of the most flagrant violators of...

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  • Use and Misuse in Regenerative Medicine

    I write this Blog as an Orthopedic Surgeon following the 2018 annual meeting of the American Academy of Orthopedic Surgeons, just concluded in New Orleans. The topic matter is of sufficient concern that Use and Abuse of Biologics became an agenda focus receiving several hours of attention. Clinical use...

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  • FDA Compliant Therapies

    For those who may have missed it, I was featured Monday night in a Fox 32 news report presented by Fox News investigative reporter Sylvia Perez. http://www.fox32chicago.com/health/customers-warn-that-doctors-are-scamming-patients-with-fake-stem-cell-claims Regular readers of my Blog are aware of the...

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  • “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-based Products: Minimal Manipulation and Homologous Use”

    On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be...

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  • Combining Bone Marrow Concentrate into the joint with Subchondroplasty

    Combining Bone Marrow Concentrate into the joint with Subchondroplasty

    We now are approaching five-year outcomes regarding the use of Bone Marrow Concentrate for Osteoarthritis of the hip, knee, shoulder and ankle. Bone Marrow contains Adult Mesenchymal Stem (MSC) cells and Growth Factors. In the beginning, the entire informed consent process focused on the MSC in bone...

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  • Regenerative options for patients receiving chemotherapy, immunosuppression or radiation therapy

    Regenerative options for patients receiving chemotherapy, immunosuppression or radiation therapy

    There has always been a category of patients for whom Bone Marrow Concentrate derived stem cells and growth factors were not a viable option. Patients who have received or are receiving chemotherapy, radiation therapy or immunosuppression have diminished stem cell viability and actual numbers. Such...

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  • Why The Center for Orthobiologic Clinical Trials?

    Why The Center for Orthobiologic Clinical Trials?

    Five years ago, I “graduated” from a 37-year career as an orthopedic surgeon with a practice based on hip and knee replacement surgery for arthritic joints. Trading my scalpel for a needle, I entered the new discipline of Cellular Orthopedics with a goal of helping patients delay, at times avoid...

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  • Report from the OrthoBiologic Institute meeting, June 08-10, 2017

    Report from the OrthoBiologic Institute meeting, June 08-10, 2017

    It was difficult for me to sit and listen to so many “show and tell” presentations not supported by scientifically overseen outcomes data. Too much anecdote about unproven methodologies; many not compliant with FDA guidance. Basically, it was frequently repeated false news. I was taken aback by what...

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  • False Stem Cell Marketing

    False Stem Cell Marketing

    The lack of scientific foundation in stem cell marketing is all around us and negatively impacting those doing the right thing in the evolving discipline of Regenerative Medicine. Yesterday afternoon, a patient for whom I successfully completed a Bone Marrow Concentrate/Stem cell procedure presented...

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  • On Cartilage Regeneration

    On Cartilage Regeneration

    Last week, my associate attended a continued medical education course held in a venue near the Wisconsin-Illinois border; a site frequently used by the Stem Cell Institute of America to host amniotic fluid marketing seminars. My colleague overheard a conversation between several physical therapists touting...

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