Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
FDA Warns About Stem Cell Therapies
Some patients may be vulnerable to stem cell treatments that are illegal and potentially harmful. September,2017
FDA News Release
FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy. January, 2019
New Google policy bars ads for unproven stem cell therapies
“Untested, deceptive treatments” can endanger consumers, Internet giant says.” October,2019
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In spite of the attempts at consumer and patient protection by the FDA and Google, the bad actors and charlatans are still out there as evidenced by the following e-mail blast I received last week:
How do I explain the continued disregard at attempts by the FDA to protect the patient? The bad actors have been inspired by models of greed and unhinged marketing. But the FDA and potentially the FTC will get to them. The FDA didn’t issue a Public Safety Notice explicitly mentioning exosomes for nothing. Also, state medical boards are enabled by statements from the FDA that exosomes are experimental drugs, and physicians aren’t supposed to experiment in their patients.
Evidence Based Medicine is the new era of Regenerative Medicine and Cellular Orthopedics
Clinical outcomes and safety of a combined autologous bone marrow concentrate intraossesous and intraarticular injection for knee osteoarthritis at 12 months. Sheinkop, et al 02/01/2020
A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2-year follow-up. Sheinkop, et al 12/2018
Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees. Sheinkop, et al 11/2018
My Current Clinical Practice
Acellular Growth Factors
Proprietary Platelet Rich Plasma and Fluid Concentrate
This is what I had done at both hips and both knees in December; and I am going skiing in Vail two week from now
Bone marrow Concentrate
Visit www.sheinkopmd.com
Adipose Based Stem Cells
Visit www.personalizedstemcells.com to learn more
To schedule a consultation, call (312) 475-1893. The field of Cellular Orthopedics is dynamic and the associated costs are also changing to increase patient opportunity.
Tags: cellular orthopedics, FDA, FDA-approved stem cell therapie, regenerative medicine