By

Ted Sand
BMC to Treat Orthopedic Conditions

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

In the previous post, I had begun a review of the distinctions between the potential utility of an IV infusion of a patient’s bone marrow concentrate and the utter futility of using amniotic fluid products currently on the market to treat anything, whether by IV or site-specific injection. One of the issues I commented on...
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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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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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Saline Used As Placebo

On Using Saline as a Placebo: When Is a Placebo Not a Placebo? Part Two

In the previous post, I reviewed evidence presented in Bar-Or, et al. concerning the potential analgesic activity of saline used as a placebo in clinical studies. The authors provided evidence that saline didn’t act as an “inert” material in clinical studies. I will cover the authors thoughts on possible mechanisms for the saline’s analgesic activity...
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Saline Injections as Placebo

On Using Saline as a Placebo: When Is a Placebo Not a Placebo? Part One

Recently, while preparing a presentation on the current status of PRP and its clinical utility, I was struck by the large number of studies that rely on physiological saline as a placebo in double blinded, placebo-controlled clinical studies. This type of study is considered to be the gold standard format for performing clinical studies, since...
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amniotic fluid therapeutic products

Implications of Using Donor-derived Exosome-laden Amniotic Fluid As a Therapy: Practical Concerns and Potential Regulatory Issues – Part Four

In the previous post, I raised the possibility that the FDA might view the presence of exosomes in amniotic fluid therapeutic products as causing the fluid to no longer be considered exempt from 21 CFR 1271, because the fluid with exosomes would no longer be considered as just a secretion. I had indicated that there were...
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Amniotic Fluid used for Therapy

Implications of Using Donor-derived Exosome-laden Amniotic Fluid As a Therapy: Practical Concerns and Potential Regulatory Issues – Part Three

In the previous two posts (Part One and Part Two), I have considered implications of what it means to have exosomes present in donor-derived amniotic fluid used for therapy. The conclusion I reached is that there is a huge void in what we know about exosomes found in amniotic fluid, so it puzzles me why...
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Exosome-laden Donor-derived Amniotic Fluid

Implications of Using Donor-derived Exosome-laden Amniotic Fluid As a Therapy: Practical Concerns and Potential Regulatory Issues – Part Two

In the previous post, I reviewed some aspects of exosomes: what they are, where they come from and the lack of human clinical studies showing efficacy in treating orthopedic pathologies. The papers on exosomes I reviewed pointed to a bright future for using exosomes as therapeutic agents, but the approach they were advancing is to...
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