US Stem Cell Inc (USRM)

[Dragon Lady]

"SVF" done in-clinic ARE "DRUGS" CASE CLOSED..uh...

It was just made UNEQUIVOCALLY CLEAR, CRYSTAL CLEAR TODAY, AS Lt. Daniel Kaffee would say...ANY processing to create "SVF" end product (stromal vascular fraction) DOES NOT QUALIFY under "same day exemption" and is thus MORE THAN "MINIMALLY MANIPULATED" and thus will fall under a "NEW DRUG CLASSIFICATION" which means it will be ILLEGAL w/o a IND in place or biologics license, FDA approval, etc

Looks like most of the little clinic businesses are about to get BULLDOZED. Gottlieb thee FDA COMMISSIONER himself, MULTIPLE TIMES NOW RECENTLY, has made a specific point to state the FDA is going to "SINGLE OUT THE MOST DANGEROUS CLINICS and focus on them first as “bad actors"....and who got the first big, formal "WARNING LETTER", uh..uh...I think that would be USCC and Kristin Comella, LOL !! And her WARNING LETTER had personal FDA PRESS RELEASE commentary added to it by thee FDA commissioner himself, good ole Mr Gottlieb. Pretty clear to me who he's got in his target sights...

https://ipscell.com/2017/11/fat-stem-cells-are-drugs-more-fda-final-guidances-point-to-a-new-era/

AND, just read THE GUIDANCE DOCUMENT, it's only 10 pages and CRYSTAL CLEAR TO UNDERSTAND, a Jr high student with a decent reading ability can understand it IMO.

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM419926.pdf


1) ANY "processing" by means such as centrifuge for ANY OTHER PURPOSE than "rinsing, cleansing, sizing or shaping" is MORE THAN MINIMAL MANIPULATION.

PAGE 7, Q-7 and thus A-7, EXPLAIN IT TO THE FREAKING TEE.

"Other processing steps, including by centrifugation or filtration, for cell isolation, cell expansion, cell activation, or enzymatic digestion generally would NOT allow the HCT/P to remain "such HCT/P" and the establishment would NOT qualify for the exemption".

GAME, SET, MATCH...STICK A FORK IN IT IF YOU ASK ME....then Examples 7-1 and 7-2 DRIVE THE NAILS IN THE COFFIN, just in case it wasn't clear enough- they're like a storybook Q/A of EXACTLY what USCC/Comella claim to do "IN CLINIC", nearly word-for-word describing their processing and "patient treatment process".

So it all means, IF it's ANY PROCESSING is used to "derive SVF", with or w/o ENZYME digestion, then "SAME DAY EXEMPTION" DOES NOT APPLY and it's thus under 21 CFR 1271 regulations and will need MAJOR FDA approvals, etc. Comella and USCC and USRM use CHEMICAL ENZYME DIGESTION and the "kit business" is based on selling a USRM "branded" chemical enzyme (collagenase which 100% PUTS THEM IN THE MORE THAN MINIMALLY MANIPULATED CATEGORY automatically- so their goose is COOKED if you ask me. STICK a fork in their big ole "clinic expansion bull crap- they're making NON FDA APPROVED "NEW DRUGS" and are already under an FDA investigation per the WARNING LETTER and multiple 483 violations going clear back to Dec 2015)

2) IF anyone is doing more than "minimal manipulation", which is 100% the case with Comella, as she uses CHEMICAL DIGESTION BY ENZYME and she produces "SVF" on the premises, aka makes a "NEW DRUG", then you're gonna face FDA investigations and probably prosecution or "enforcement actions" according to FDA commissioner Gottlieb's comments today.

Comella has outlined in great detail, how she processes FAT into "SVF" and it ain't "minimal manipulation" and according to EXAMPLES 7-1 and 7-2 of the new guidance document- WOULD NOT QUALIFY FOR ANY EXEMPTION AS A "SAME DAY SURGICAL" blah, blah, blah BS..no way, no how..it's in plain English.





AND, Comella "ON THE RECORD" in a paper she published, DESCRIBING IN GREAT DETAIL, how she uses the U.S. Stem Cell Inc (USRM) "stem cell extraction and processing KIT" (where they're making a lot of their revenues from) to PROCESS VIA CHEMICAL ENZYME DIGESTION, FAT into "SVF END PRODUCT"...clear as day....

https://www.ncbi.nlm.nih.gov/pubmed/28086781?dopt=Abstract

https://link.springer.com/article/10.1186/s12967-016-1109-0



Journal of Translational Medicine
December 2017, 15:12
Effects of the intradiscal implantation of stromal vascular fraction
plus platelet rich plasma in patients with degenerative disc disease

Authors
Authors and affiliations
Comella Kristin Email author Silbert Robert Parlo Michelle

READ WHAT COMELLA FREAKING WROTE, and try and tell me that meets "SAME DAY MINIMAL MANIPULATION", LOL !! CHEMICAL ENZYME co-mingled with the patients fat, blood, bodily fluids they sucked-out in a mini lipo procedure....uh....uh.....

QUOTE:

"Cell preparation and study intervention
From each patient, approximately 60 ml fat was collected using a 3 mm
aspiration cannula with prior administration of tumescent solution. The
tissue was prepared using AN ADIPOSE STROMAL VASCULAR PREPARATION KIT
(US Stem Cell, Inc. Sunrise, FL). The adipose tissue was washed with
buffered saline and digested using COLLAGENASE (Cellase, US Stem Cell,
Inc., Sunrise, FL) at 37 °C for 12–15 min with agitation at 5-minute
intervals. The suspension was centrifuged at 1200×g for 5 min to collect
the SVF as a pellet. The pellet was washed twice and filtered through a
100 µm cell strainer with buffered saline to remove any residual enzyme.
The final SVF pellet was resuspended in approximately 1–3 ccs of
autologous platelet rich plasma (PRP). PRP was prepared by collecting
autologous peripheral blood and centrifuging at 500 g for 8 min.""

THAT is CHEMICAL ENZYME freaking "DIGESTED" body fat/blood/etc and thus heavily "MODIFIED" on the premises to create "SVF" (EXACTLY the entire crux of the very serious FDA formal "WARNING LETTER" and what it states)- no freaking way is that gonna meet that new draft guidance PAGE 3 VERY SPECIFIC "DEFINITION" of good ole "MINIMALLY MANIPULATED" IMO, and many, many other experts have weighed-in and stated the same, including a PhD blogger/scientist and many other's opinions I've read, in great detail.