Tag

human-derived materials
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
Cord Blood-Derived HCT PS

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part Two

In the last post, I covered the rapidly expanding sales of donor cord blood-derived products, despite the fact that the FDA considers cord blood to be a biological drug, and requires companies to perform an IND to gain approval to sell cord blood units. In the previous post, I focused on a company, Invitrx, which...
Read More
Pluripotent Stem Cells

What’s Up with All of the So-Called Pluripotent Stem Cell Injections Everyone is Getting? Part Two

In the previous post I had begun a review of the nature of totipotent and (real) pluripotent stem cells. I was motivated to comment on this apparently confusing area due to the ever more frequent statements patients can find on physician/clinic websites touting the miracles of being injected with what the sites claim are pluripotent stem...
Read More
Pluripotent Stem Cell Injections

What’s Up with All of the So-Called Pluripotent Stem Cell Injections Everyone is Getting? Part One

My boss, Dr. David Karli, frequently fields questions from friends, colleagues and patients about his opinion on the value for someone to receive a seemingly magical regenerative medical injection that will cure all that ails them. After I investigate the link he sends me, I usually find the words “pluripotent stem cell” somewhere in a...
Read More
SVF Drug Violations

FDA Hammers A Flaunter of the Rules Against Making and Treating Patients with Fat Tissue-derived Stem Cells – Part Eight

Previously, I wrote about several significant issues identified in the FDA’s audits of Ms. Comella’s US Stem Cell Clinic (USSCC) with respect to making stromal vascular fraction (SVF) preparations to treat patients. Needless to say, the FDA has come down hard on the USSCC operation by auditing the clinic’s protocols against a cGMP standard, which...
Read More
1 2 3