Tag

human-derived materials
Contaminated Umbilical Cord Blood

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Four

Over the past three posts (Part One, Part Two and Part Three) I have cited sections of 21 CFR 1271 as they relate to the manufacturing of HCT/Ps, such as cord blood-derived products produced by Genetech and sold by Liveyon that resulted in 15 patients (so far) suffering often severe adverse events due to having...
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Liveyon Blames FDA

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Three

In the past two posts (Part One and Part Two) I have covered details about a serious lapse in quality control on the part of Genetech, the source of contaminated cord blood-derived products, which was injected into 15 patients who have developed serious infections, as tracked by the CDC. Genetech sold the donor-derived cord blood...
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Genetech Failure

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part Two

In the previous post, I had begun to review the Warning Letter the FDA issued to Genetech, who was the supplier of cord blood-derived products to Liveyon, who in turn sold the contaminated vials of their product to physicians across the USA. While the most shocking observation the FDA made in the Warning Letter was...
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Genetech Provides Contaminated Donor-Derived Therapy

The Danger of Using Donor-derived Materials Without Good Quality Control: the Liveyon Debacle – Part One

Recently, the CDC announced to the public the existence of an outbreak of infected patients who had received a donor-derived regenerative therapy in several states: “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.” It isn’t a...
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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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