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TOPIC: LVAD's to the rescue ?

LVAD's to the rescue ? 06 Oct 2013 10:34 #928

  • myownhedgefund
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Interesting twist in cardiac healing with LVAD usage.

online.wsj.com/article/SB10001424052702303643304579107573374207380.html
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LVAD's to the rescue ? 06 Oct 2013 11:41 #929

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Yes- very interesting.

Key here is:

The device, called an LVAD, takes over most of the heart's main pumping function and was designed initially to enable patients to survive until a donor heart became available for transplant. But doctors have discovered to their surprise that the heart can get better on the pump. When they remove it later to perform a transplant, the heart is sometimes dramatically improved.


Instead of (or in addition to) a excessive regimen of medication, a few stem cells would certainly help the heart to recover faster also, dont you think?

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

LVAD's to the rescue ? 06 Oct 2013 21:13 #930

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Thats the plan Fas...stem cells give a better result...we all enjoy our profits and watch, while the company we own helps patients with a reasonably simple procedure live a better life. So far...just a dream !!!

These patients had 2 surgical procedures...install the LVAD and then to remove it.
LVAD's alone are not cheap.

For those who mostly just read the board...the included chest x-rays of one patient in the article show a very good example to visualize what is being discussed here.
The large floppy heart of cardiomyopathy ( Heart failure)
Then the next 2 show the restoration of a normal size and shape of the heart post LVAD installation and then the heart keeping a good portion of the result after removal and some time has past. Anyway...if you havent seen these types of x-rays in the past...I feel it helps give a understanding of the disease process and how we someday hope to repair it.

Fas...BTW...had a problem this afternoon with the site...I'll send you a email to your cytx-investor.com address

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LVAD's to the rescue ? 06 Oct 2013 21:22 #931

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Fas...yahoo email acting up...I post you a message under "messages from Housekeeper" Subjest Title "unwanted guest"

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LVAD's to the rescue ? 22 Jul 2014 08:50 #1897

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Seems worthy of another look now!

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LVAD's to the rescue ? 22 Jul 2014 10:15 #1901

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Well-

This is quite big news, so kind of surprise that it does nothing to the stock price.

Actually - last year summer, the birds were already whistling this news from the tree tops. And a lot of folks knew this was coming.

Actually -MesoBlast recently had results already on a similar study, so yes we will have a look at that, in due course- at present - just the announcement and according to a slide once shown by Cytori - there must be two more clinics like this. :whistle:

SAN DIEGO, July 22, 2014 – The Cardiovascular Cell Therapy Research Network (CCTRN), has selected Cytori (NASDAQ: CYTX) Therapeutics, Inc. to supply adipose-derived regenerative cells (ADRCs™) for a clinical trial aimed at evaluating the safety and feasibility of treating patients with Left Ventricular Assist Devices (LVADs). The CCTRN is supported by grants from the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH). This trial, named CELLVAD-ADRC, will explore outcomes following administration of a regenerative cell preparation from adipose tissue into the patient’s heart muscle 60 to 90 days after placement of an LVAD.

“Cytori is honored to have been selected by the CCTRN to collaborate on this trial. The CELLVAD-ADRC trial is consistent with our commitment to developing cell therapies for heart failure,” said Marc H. Hedrick, President and CEO of Cytori Therapeutics. “We look forward to understanding how ADRCs may benefit patients with a more advanced stage of heart failure than those being treated in our U.S. ATHENA trial.”

CELLVAD-ADRC is a prospective, phase I, double-blind, randomized trial that will enroll 34 patients with end-stage ischemic heart disease who have received an LVAD in the preceding 60 to 90 days. Following an open-label phase where the initial 10 patients will all receive cell therapy subject to a safety committee review, 24 patients will be randomized 1:1 to receive either ADRCs or a placebo. The trial will assess safety and feasibility endpoints including adverse events, cardiac function, exercise tolerance, myocardial viability and perfusion, and quality of life over a one year follow-up period. The trial is funded by the NHLBI through its Cardiovascular Cell Therapy Research Network (CCTRN), which will oversee trial design, implementation, and enrollment across its network of seven U.S. trial sites, which lead the field of cardiovascular cell therapy.

Cytori Cell Therapy is a mixed population of autologous adipose-derived regenerative cells (ADRCs™) extracted using Cytori’s innovative and proprietary Celution® System, creating new treatment opportunities for currently unmet medical needs. Adipose tissue is the richest source of stem and regenerative cells in the body. LVADs are mechanical devices used in hearts too weak to pump blood throughout the body. They are commonly implanted in patients waiting for a transplant or who do not qualify for a transplant but need additional pumping support.

According to the American Heart Association, there are approximately 5.1 million Americans currently living with heart failure. For patients with a more advanced condition of heart failure, Ventricular Assist Devices are sometimes an option. In 2010, more than 1.400 LVAD devices were implanted into patients in the U.S. alone.

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LVAD's to the rescue ? 22 Jul 2014 15:06 #1902

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Fas, This is beyond ''quite big''. This is HUGE. :woohoo:

The government is funding what is a logical extension of the ATHENA I & II trials ...... ie. those individuals that are on the heart transplant list but whose condition is so bad that they require a hugely expensive LVAD device/procedure. The incremental cost of the Celution procedure is peanuts compared to the LVAD procedure cost. A positive result in this small trial (along with that from ATHENA) will, I believe, ensure that everyone who is on a heart transplant list (100,000 in the USA) will be screaming to get this procedure done. In fact I would imagine that all the healthcare insurance companies would be insisting that this procedure be undertaken prior to LVAD implant.

It is very positive that a large number of the CCTRN clinics undertaking this trial are the same as those in the ATHENA trials. The broad exposure to the thought leaders in the cardiovascular space is immense. How long can it be before these same doctors will be wanting to carry out trials in the Acute Heart Attack indication ?????? :grin:

Also lets not forget that this is at long last a swing away from the orthodoxy which dictated that US government funding of clinical trials use Bone Marrow sourced stem cells. I believe that ADRC are finally capturing the imagination of the MEDICAL ESTABLISHMENT. BP cannot be far behind. :vegas:

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LVAD's to the rescue ? 22 Jul 2014 15:21 #1903

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Yes John- this is huge but will not be recognized as such in the short term.

To me the major reason is ARRHYTHMIAS or better lack thereof with ADRCs. With LVADs very important and with MI ´s as well.

Its all "Caplan"- ADRCs from the vascular system (in fat) are simply natural to the heart.
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LVAD's to the rescue ? 22 Jul 2014 21:34 #1904

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rongside...I agree a nice extension to ATHENA trials which are going after the mid-stage heart failure patients. Most of these end stage patients wont get their organs...just not enough hearts. If you can implant a LVAD, treat with stem cells and after the stem cells have done their work (in about six months) you then have the added confidence to remove the LVAD and let the patient survive on their own. The whole process wont be cheap...but niether is heart transplant surgery. Best part is no lifetime of rejection drugs !!! Fits nicely with the WSJ article.

I also do agree with Fas that short term really not a market mover. Phase 1 announcements really never are...even if funded. Its still a long road to approval and reimbursement. Lets pray that we have a decent update on ATHENA enrollment...two years+ to get the first fortyfive patients enrolled is just unbelievable.

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LVAD's to the rescue ? 24 Jul 2014 08:43 #1905

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I downloaded the published study of MSB MPCs on LVAD patients.

The sponsors appear to be the same- so they are still looking for the "best" answer to the problem.

File Attachment:

File Name: MSB-LVAD-clinic.pdf
File Size: 340 KB
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:
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