US Stem Cell Inc (USRM)

[Dragon Lady]

"ADD" a "second" site? But wait? The ORIGINAL documents for this trial, as uploaded to clinicaltrials.gov clear BACK in March, 2014 already listed THREE SITES as being in the trial?

So going from an original claim of "THREE sites enrolling" to now "TWO SITES" is called "expanding" in the PR? Fascinating IMO?

This "Dr. Julian Gershon" of today's "new PR" was ALREADY listed, back in March, 2014 as being one of the 3 sites. So how does it now get "added" as a "2nd" site- if the "claim" was made back in March, 2014 that is was already part of the study and already enrolling?

How does that work?

http://clinicaltrials.gov/show/NCT02097862

Look at the date stamp and "last verified" stamp, MARCH 2014 and states NO CHANGES MADE, "last updated N/A", thus this would be the original info uploaded, 8 months ago? It clearly shows and states THREE sites as "enrolling", so how can today, 8 months later a "second" site be added to just ONE site? How?:

"Locations
United States, Colorado
Dr. Gershon Recruiting
Grand Junction, Colorado, United States
Contact: Carissa Matton [e-mail]
United States, Indiana
Dr. Silbert Recruiting
Indianapolis, Indiana, United States
Contact: Carissa Matton [e-mail]
United States, Texas
Dr. Lightner Recruiting
Laredo, Texas, United States
Contact: Carissa Matton [e-mail]
"

I count THREE there? So now it's been ONE all along, Dr. Silbert, and what happened to the the Dr Gershon of Colorado and the Dr Lightner of Texax? They just vanished for a while I guess? And now, at least the one, is being re-introduced in a BHRT "PR" as being "new" and the "2nd site" being "added"??

Seems like typical BHRT confusion and mis-match, IMO, where the PR and previous info, already published just somehow don't jive with each other?

Further, the PR today says it will be "randomized". The clinicaltrials.gov sight say NON RANDOMIZED, open label??

So which is it? The official, published info loaded onto clinicaltrials.gov or now a "PR" blast from Bioheart- which seems to have contradicting info with the clinicaltrials.gov site? Which should be trusted as correct and accurate?

"Official Title: An Open Label, Non-Randomized, Multi-Center Study To Assess The Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra-Discally in Patients With Degenerative Disc Disease"

From PR release today:
"Bioheart has initiated this new study for DDD which will include a randomized control arm."

So which is it? Randomized or Non-randomized, cause that's a HUGE change in a trial and its design and execution? How can that just "randomly" be changed on the fly?

Further, this PR is vague as usual IMO. HOW MANY ARE ENROLLED then so far at what must presently, to date, be the ONE and ONLY site (not the THREE stated on clinicaltrials.gov?) It doesn't say in the PR how many are already enrolled of the "up to" 100?

It uses the words enroll "up to 100" patients, which really doesn't mean much. That wording, the way it is written, it means they "might" enroll 1 patient at which point the PR would now be "true", or maybe 5 or maybe 25, who knows what "up to" means? It's open ended wording, with no finite, mathematical defined or known number, it's a range.

Up to 100, from a mathematical standpoint would mean any number great than 1 and less than or equal to 100. 1 < X </= 100

It should read, IMO (according to how a typical, clinical study would be designed and run, meaning when the trial is designed, they already know a fixed number or the minimum number of patients required to reach statistical significance)- it would read for example, "The study will enroll a minimum of 86 patients and up to as many as 100 patients to meet the statistical end-points needed, blah, blah, blah".

So, how many have been or will be enrolled as of today? From the PR (typical IMO) no one can know or tell?

Yet, the clinicaltrials.gov site said they expect initial completion in March 2015, just a little over 3 months away?

"Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)"

That doesn't seem likely if they're just now "adding" the 2nd site of what it says is a MULTI CENTER TRIAL from DAY ONE? Again, how would that "work"?

I don't get it? It's murky and confusing PR IMO? What happened to the site in Texas, listed right there on clinicaltrials.gov? Is that going to be re-released in a later "PR" too?