US Stem Cell Inc (USRM)

[Dragon Lady]

Stem cell "WILD WEST" unregulated- says AP (Associated Press) and U.S. News and World Report-

FASCINATING article IMO. Really amazing journalism - and full of some real interesting key words about companies doing "training" and "opening clinics" etc in the highly un-regulated "WILD WEST" of the "stem cell" field- according to this journalism piece, even quoting the highly respected stem cell researcher at U.C. Davis and blogger, "Dr. Paul Knoepfler," (Knoepfler recently published a blog piece on BRHT, Bioheart)

http://www.usnews.com/news/business/articles/2015/05/18/stem-cell-wild-west-takes-root-amid-lack-of-us-regulation

http://www.ipscell.com/2015/05/bioheart-on-the-edge/

Pretty fascinating reading IMO. Real fascinating. One has to wonder if the FDA is about to step in and really start cracking their regulatory whip here real soon? Seems like a real possibility IMO.

Isn't part of the BHRT big "new plan" thingy- got a great deal to do with offering some cash for "treatment" stem cell "clinic" now on U.S. soil, in Florida? That's what's in the latest 10-Q, no? How do they do that if what they have as "treatments" are not FDA approved?

I never could figure that one out? Never made any sense to me personally? Still doesn't even more- now, after reading that U.S News and World Report/ AP Associated Press journalism piece.

http://www.usnews.com/news/business/articles/2015/05/18/stem-cell-wild-west-takes-root-amid-lack-of-us-regulation

Quoting the article:

"Unproven stem cell procedures flourish across the US, outpacing regulation

By MATTHEW PERRONE, AP Health Writer

BEVERLY HILLS, Calif. (AP) — The liquid is dark red, a mixture of fat and blood, and Dr. Mark Berman pumps it out of the patient's backside. He treats it with a chemical, runs it through a processor — and injects it into the woman's aching knees and elbows.

The "soup," he says, is rich in shape-shifting stem cells — magic bullets that, according to some doctors, can be used to treat everything from Parkinson's disease to asthma to this patient's chronic osteoarthritis.

"I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."

It's quackery, critics say. But it's also a mushrooming business — and almost wholly unregulated.

The number of stem-cell clinics across the United States has surged from a handful in 2010 to more than 170 today, according to figures compiled by The Associated Press. Many of the clinics are linked in large, for-profit chains. New businesses continue to open; doctors looking to get into the field need only take a weekend seminar offered by a training company.

Berman, a Beverly Hills plastic surgeon, is co-founder of the largest chain, the Cell Surgical Network. Like most doctors in the field, he has no formal background in stem cell research. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis, lupus and erectile dysfunction.

There are clinics that market "anti-aging" treatments; others specialize in "stem-cell facelifts" and other cosmetic procedures. The cost is high, ranging from $5,000 to $20,000.

Berman and others point to anecdotal accounts of seemingly miraculous recoveries. But while stem cells from bone marrow have become an established therapy for a handful of blood cancers — and while there are high hopes that the cells will someday lead to other major medical advances — critics say entrepreneurs are treating patients with little or no evidence that what they do is effective.

Or even safe. They point to one stem-cell doctor who has had two patients die under his care.

"It's sort of this 21st century cutting-edge technology," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis. "But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West."

___

DISCOVERING 'LIQUID GOLD'

Doctors in South Korea and Japan pioneered the fat-based stem cell technique, using it to supposedly enhance face lifts and breast augmentation. For years, U.S. patients would travel to hospitals in Asia, Latin America and Eastern Europe — places where regulation is more lax than in the United States — to have these procedures as part of the international "stem cell tourism" trade.

Plastic surgeons in the U.S. quickly realized the financial potential of the fat they were already taking out of patients' bellies and backsides through liposuction — something that had been disposed of previously. Berman calls it "liquid gold."

Some early adopters have expanded into chains, offering doctors across the country a chance to join the franchise after buying some equipment and attending a seminar. These doctors sometimes appear on local TV news broadcasts, drumming up new business from patients and stoking interest from other doctors......."

Wow, simply amazing to me. Staggering amazing. This has to be on the FDA's radar IMO. I just don't see how this stuff can't be. What's fascinating to me- is many of the claims made by some of the "clinics" described in that AP article, almost match verbatim what I read on the U.S. Stem Cell Clinic web site- the company now partly owned by BHRT.

http://usstemcellclinic.com/

http://www.ipscell.com/2014/12/breaking-new-fda-draft-guidance-views-fat-stem-cells-as-drugs/

Quote right from that BHRT operated website:

"Is this procedure FDA approved?
No it is not; however our procedure falls under the category of physician’s practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment. Our procedure is compliant within the guidelines listed in the FDA Code of Federal Regulations 21 Part 1271. We meet FDA guidelines by providing a same-day procedure done entirely in clinic with only minimal manipulation of a patient’s own cells which are then immediately delivered back to that patient."

Most recent filed BHRT 10-Q, PAGE 12:

"Investment is comprised of a 33% ownership of U.S. Stem Cell Clinic, LLC, accounted for using the equity method of accounting. The initial investment in 2014 and 2015 of cash and expenses paid on U.S. Stem Cell Clinic, LLC’s behalf was in aggregate of $54,714. The Company’s 33% income earned by U.S. Stem Cell Clinic, LLC of $3,966 for the three months ended March 31, 2015 (inception to date loss of $5,151) was recorded as other income/expense in the Company’s Statement of Operations in the appropriate periods and increased the carrying value of the investment to $49,563."

AND, same 10-Q filing, PAGE 26:

"US Stem Cell Clinic, LLC, (“SCC”), a partially owned investment of our company, is a physician run regenerative medicine / cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. SCC is operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and adipose tissue and also utilize platelet rich plasma."

So BHRT seems to be making some "claim" that they're somehow operating this "clinic" and doing procedures and offering "treatments/therapies" using their stem cell "drugs" (the FDA has deemed stem cells to be "drugs" from all that I've read, including the FDA's own web site) doing this "stuff" on humans, on U.S. soil via some interpretation/reading of some FDA section of law- but not that the FDA has ever approved a single, actual "stem cell" whatever that BHRT is now doing? Wow, IMO. Pretty wild stuff to me- just what that AP/U.S. News World Report reporting/journalism article seems to be discussing from my read on it.

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm

http://www.ipscell.com/2014/12/breaking-new-fda-draft-guidance-views-fat-stem-cells-as-drugs/

http://www.nature.com/news/fda-s-claims-over-stem-cells-upheld-1.11082

WOW, IMO. Pretty fascinating stuff- this working seemingly "on the edge" of what the FDA says or deems legal on U.S. soil? Kinda Wild West to me, just like the Associated Press investigative journalism/medical writer article says IMO.

Is Bioheart really even pursuing FDA clinical trials for "heart stuff" any more? Really, are they? It sure doesn't seem like it to me, personally? It's been totally de-emphasized it seems in these most recent SEC filings, they have no money to fund any trials as they're nearly cash broke at any given time, and now all their "talk" and "PR" stuff and all- all seems to center around this "new' whatever "clinic" and "doctor training" and now "animal" stuff and all? Clinical trials- just doesn't even seem like a realistic possibility anymore to me and their trials they did have once, the FDA ones, are now going on 5 or 6 yrs old at least, just parked and going nowhere?

I'm not even sure what real business they're in anymore, that's my personal thoughts? Now some odd-ball part "clinic" operator/owner and "teaching physicians" branch or "division" or whatever and all this other "stuff" like "animals" now too - when the entire company is like 4 full time people probably, maybe 5 tops? I personally don't even get how all that's even possible then- supposedly running and managing and doing and funding all this "new stuff"- let alone, being an actual medical R&D clinical trials company like they at least sorta seemed to be trying to be, in the past?

Totally confusing to me- just makes no sense. But hey, that's just me.

It's about a 1/2 CENT stock looks like to me- that looks like the new "normal" here, so maybe I'm not the only one "not getting it" perhaps? Maybe? Who knows?