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Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work
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TOPIC: Could Be The End

Could Be The End 05 Aug 2014 16:11 #1968

  • rothco619
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No other way to say it but we are fucked. Athena on hold. Just want to say that whoever has been in direct contact with Saad or Hendricks
and has taken them at there word should now understand what a complete group of liars these guys are. How are they ever going to fix the balance sheet and keep from going under. Will BARDA disappointment be the final nail in the coffin. Guess they earned the compensation package they just voted themselves.

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Could Be The End 05 Aug 2014 16:23 #1969

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Cytori Provides Update on ATHENA Trial Status<CYTX.O>
Business Wire
4:05 PM Eastern Daylight Time Aug 05, 2014
pdf.reuters.com/htmlnews/8knews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20140805:nBw056563a
SAN DIEGO--(Business Wire)--
Cytori Therapeutics (NASDAQ: CYTX) has placed enrollment in the ATHENA and
ATHENA II trials on clinical hold and therefore anticipates that it will not be
possible to complete enrollment of the ATHENA I trial prior to the end of 2014
as previously anticipated. The decision to place the trials on hold was based on
a safety review of reported cerebrovascular events. Symptoms occurred in three
patients, of which two patients` symptoms fully resolved within a short period
of time and the third patient has had substantial resolution of symptoms. Such
events had not been previously reported in Cytori`s other cardiovascular trials
and appear to be related in part to the medical co-morbidities in the treated
population and the complex nature of the procedures involved in the trial.
The U.S. ATHENA and ATHENA II clinical trials are randomized, double-blind,
placebo controlled studies designed to evaluate the safety and feasibility of
adipose-derived regenerative cells (ADRCs) in heart failure patients with
ischemic heart disease who are already receiving maximal therapy with no options
for revascularization. The procedure involves a fat harvest through small volume
liposuction, cardiac catheterization, electromechanical mapping of the heart to
determine where to inject ADRCs (or placebo), the actual ADRC (or placebo)
injection and related data collection and monitoring activities.
Cytori has been working with the FDA, an independent Data Monitoring Committee
The following story was published on Thomson ONE:
For information on Thomson ONE go to www.thomson.com/financial(DMC) , trial investigators and external expert consultants to fully understand
any adverse events and to carefully define adjustments to the protocol intended
to minimize risks to patients and to improve the benefit to risk profile of the
study.
Adverse events are expected in trials in which participants suffer from advanced
cardiac disease and protocol revisions during phase II safety and feasibility
studies in compromised populations are common. Cytori is committed to refining
the trial protocol as needed, to mitigate risks as much as possible. Updated
information regarding enrollment projections will be communicated upon final
protocol revisions and agreement amongst the investigators, the DMC and FDA as
to the safety and feasibility of continuing the trial as amended.

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