Tag

exosomes
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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