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useful shot in the arm
BMC via IV Therapy

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part Three

Over the previous couple of posts, I have been reviewing the love/hate relationship the FDA seems to have with therapy provided by an IV route. They issued a blanket determination in the MM/HU Guidance that IV therapies of HCT/Ps would be considered risky and therefore physicians offering IV therapies of HCT/Ps would be more rapidly...
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BMC via IV Infusion

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part Two

In the previous post, I reviewed the risk-based approach the FDA is taking in dealing with the free-for-all that currently exists in the world of regenerative medical therapies, like BMC and PRP. Actually, PRP and BMC don’t seem to raise red flags with the FDA, unlike amniotic fluid, cord blood-based products, fat-derived SVF in orthopedic...
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IV Administration BMC

Considerations On the Regulatory Status of IV Administration of BMC: A Useful Shot in the Arm? Part One

During a presentation at the recently concluded MedRebels conference, Dr. Don Buford indicated that there were no “homologus use” indications associated with IV infusion of autologous bone marrow concentrate (BMC). He made this point, in part, because of language the FDA has included in 21 CFR 1271.3 as follows: The following articles are not considered...
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BMC Therapy vs Amniotic Fluid

Differences Between IV Infusion of BMC and Amniotic Fluid – Part One

No doubt some of you who regularly read my posts probably thought that I had lost my mind during the just completed set of three posts on considerations for using IV infusion with autologous BMC to boost up cellularity in a patient’s depleted bone marrow depots. I suspect you couldn’t believe that I would write posts...
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