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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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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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Exosome-laden Amniotic Fluid as Therapy

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

In the previous two posts, I covered aspects of a recently emailed ad from Apex Biologix I received in which they wanted everyone to know how safe and useful their Allogenic Birth Tissue amniotic fluid product is. Relates Posts: Dissecting Ads for Regenerative Therapies: The Selling of Amniotic Fluid Products – Part One and Part Two...
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Value of Exosomes in Amniotic Fluid Products

Dissecting Ads for Regenerative Therapies: The Selling of Amniotic Fluid Products – Part Two

The focus of the previous post was on reviewing statements I found puzzling that appeared in an ad for an amniotic fluid product offered for sale by Apex Biologix. I explained that amniotic fluid without viable cells or micronized tissue is considered by the FDA to be excluded from 21 CFR 1271, much like blood, blood...
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Ads Selling Amniotic Fluid Products

Dissecting Ads for Regenerative Therapies: The Selling of Amniotic Fluid Products – Part One

Recently, I received an ad from Apex Biologix sent via email. Their ad focused on a product made from amniotic fluid collected from donors in the USA. The ad covered the composition of their product, how it was produced and what it might be used for. Since the ad made a number of statements that...
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Method of Ratios and PLT

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part Two

In the previous post, I had shared a couple of comments from physicians (Drs. Sairam Atluri and Dr. Edward Marcheschi) that had been made on the trio of posts on the Arthrex Angel in which I concluded that the Arthrex Angel system was a lemon as a PRP/BMC processing technology. In exploring aspects of the...
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Arthrex Angel and Method of Ratios

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part One

The posts that I write are available on the Greyledge website and are also distributed on LinkedIn. I would like to share a couple of LinkedIn comments from physicians who responded to the last three posts that have covered this question: Is the Arthrex Angel PRP/BMC processing system a lemon or has Arthrex’s marketing group made...
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Arthrex Angel System

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Three

In the previous two posts (Part One and Part Two), I have reviewed aspects of the performance of the Arthrex Angel system, which is being marketed to orthopedic surgeons to produce PRP and BMC for therapeutic treatments. I have covered the basics of the system and reviewed data from a publication that compared the cellular...
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