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TOPIC: TCTMD article on PRECISE

TCTMD article on PRECISE 22 Apr 2014 08:45 #1578

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Pretty subdued article if you ask me- :whistle:

First-in-Man Study Demonstrates Safety, Feasibility of Adipose-Derived Cell Therapy for Heart Failure

In a ‘no options’ patient with chronic ischemic heart disease, transendocardial injection of autologous adipose-derived regenerative cells appears safe and yields signals of efficacy, including preservation of functional capacity over 18 months. The findings from a first-in-man study were published online April 7, 2014, ahead of print in the American Heart Journal.
Data from the PRECISE trial were initially presented at the Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, CA, in November 2011.
Francisco Fernández-Avilés, MD, PhD, of Hospital General Universitario Gregorio Marañón (Madrid, Spain), and colleagues randomized, in a 3:1 fashion, 27 patients with chronic ischemic cardiomyopathy and no option of revascularization to receive transendocardial injection of autologous regenerative cells (mean 42 x 106 cells in a 3 mL volume; n = 21) or placebo (n = 6) at 4 European sites.
Fat-Cell Harvesting Safe
All patients first underwent harvesting of abdominal adipose tissue. The regenerative cells were isolated using the Celution System (Cytori Therapeutics; San Diego, CA) and then delivered in 15 injections guided by the catheter-based NOGA XP navigation system (Biologics Delivery Systems; Diamond Bar, CA). Control patients received the same pattern of injections and solution but without cell therapy.
Fat harvesting, performed under local anesthesia, was well tolerated with no procedure-related complications. NOGA mapping and transendocardial injection were not associated with sustained arrhythmias.
In the cell-therapy group, 1 patient suffered mild pericardial effusion after injection, another had a periprocedural NSTEMI, and a third experienced TIAs at 6 and 11 months after treatment. Of 5 deaths, 3 occurred in the cell-therapy group, and 1 of those was cardiac-related. No malignant arrhythmias were associated with the procedures or were seen at follow-up. Moreover, there were no significant changes from baseline in laboratory parameters.
Modest improvements in New York Heart Association (NYHA) and Canadian Cardiovascular Society class were seen in both arms, although there were no significant changes in LVEF or LV volume within each group over time or between groups. LV total mass, as measured by cardiac MRI, increased from baseline to 6 months in the cell-therapy group (from 128.1 ± 26.0 g to 149.5 ± 32.4 g; P < 0.001), as did global wall motion score index (from 2.1 ± 0.6 to 1.7 ± 0.9; P = 0.04). Both of these metrics remained unchanged in the control group.
In terms of exercise tolerance, metabolic equivalent values were preserved over 18 months in the treatment group, while they decreased in the control group (P = 0.001). Over the same period, maximal oxygen consumption (MVO2) was maintained in the cell-therapy group but declined in the control group (from 19.0 ± 8.2 mL/kg/min to 14.8 ± 16.9 mL/kg/min; P = 0.001).
In addition, the summed stress-rest difference score at 6 months was lower in the treatment group (P = 0.02) but remained unchanged in the control group, suggesting less stress-induced ischemia in cell-therapy patients. This difference was sustained over 18 months. Furthermore, visual summed wall motion at 6 months increased in cell-treated patients (from 25.2 ± 11.5 to 27.6 ± 10.8; P = 0.03) but not in the control group.
Advantages Over Bone Marrow Cells
In a telephone interview with TCTMD, co-principal investigator Emerson C. Perin, MD, PhD, of the Texas Heart Institute (Houston, TX), explained the rationale behind the researchers’ choice of therapeutic cells. “We have studied bone marrow in heart failure, and it is a relatively weak therapy. Now we are looking for stronger therapies, and this may be one of them,” he said.
Not only are adipose-derived cells relatively easy to obtain and ready for injection within hours of harvesting, but their quality and composition appear to be more favorable than those derived from bone marrow, Dr. Perin contended. Key mesenchymal cells are far more abundant in the stromal vascular fraction isolated from adipose tissue, which is also rich in mesenchymal-like pericytes and endothelial progenitor cells, he said, adding that pro-healing macrophages predominate over the pro-inflammatory type.
Adipose-derived regenerative cell therapy is thought to work primarily through a paracrine mechanism “on multiple fronts,” Dr. Perin said, releasing pro-angiogenic and anti-apoptotic factors, for example, rather than by directly regenerating heart muscle. In addition, noncardiac research shows that the therapy may modify scars in such a way that the tissue of infarcted heart muscle might become more compliant, he reported.
Furthermore, use of regenerative cells from adipose tissue avoids an important drawback of autologous bone marrow since fat cells are much less affected by variables such as age and comorbidities, Dr. Perin noted, adding that the observation requires confirmation.
Another important component of the current strategy is the 3-D mapping of the left ventricle with the NOGA navigation system, Dr. Perin said. This enables specific targeting of tissue that is ischemic yet still viable.
Safe with a Hint of Efficacy
Since all patients were very sick and the cell strategy was brand new, the main goal of the PRECISE trial was to show that the procedure was well tolerated and safe, Dr. Perin emphasized.
But the MVO2 trend in particular is an important efficacy signal, he asserted. Over follow-up, placebo patients’ peak oxygen consumption declined to a threshold that qualified them for heart transplant, while those treated with cell therapy remained stable. Furthermore, MVO2 is a more important measure of functional capacity than LVEF and is a strong predictor of mortality, Dr. Perin noted.
Next up for adipose-derived cell therapy in chronic ischemic heart disease is ATHENA, a randomized controlled trial currently enrolling 45 subjects at 8 US centers, he reported.
Study Details
Patients had NYHA class II-III symptoms, LVEF ≤ 45% as determined by 2-D transthoracic echocardiography, and evidence of a stress-induced reversible perfusion defect on SPECT within 1 month of enrollment.

Source:
Perin EC, Sanz-Ruiz R, Sánchez PL, et al. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: the PRECISE trial. Am Heart J. 2014;Epub ahead of print.

Disclosures:
The PRECISE trial was supported by Cytori Therapeutics.
Dr. Fernández-Avilés reports no relevant conflicts of interest.
Dr. Perin reports receiving consulting fees from Amorcyte, Cytori Therapeutics, St. Jude Medical, and Teva; his spouse is employed by Cytori.

Link to article: TCTMD article
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TCTMD article on PRECISE 23 Apr 2014 08:50 #1584

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The publication- abstract only ( :cry: - contrary to the APOLLO publication, which was free- this one costs) - link - 3 years PRECISE- at AHJ

Adipose-Derived Regenerative Cells in Patients with Ischemic Cardiomyopathy: The PRECISE Trial☆
Emerson C. Perin, MD PhD, Ricardo Sanz-Ruiz, MD, Pedro L. Sánchez, MD PhD, José Lasso, MD PhD, Rosa Pérez-Cano, MD PhD, Juan C. Alonso-Farto, MD PhD, Esther Pérez-David, MD PhD, Maria Eugenia Fernández-Santos, PhD, Patrick W. Serruys, MD PhD, Henrick J. Duckers, MD PhD, Jens Kastrup, MD, Steven Chamuleau, MD PhD, Yi Zheng, MD, Guilherme V. Silva, MD, James T. Willerson, MD PhD, Francisco Fernández-Avilés, MD PhDemail address
Received 26 June 2013; accepted 17 March 2014. published online 07 April 2014.
Accepted Manuscript


Aims
Adipose-derived regenerative cells (ADRCs) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy. We performed the first randomized, placebo-controlled, double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy.

Methods and Results
Procedural, postoperative and follow-up safety endpoints were monitored up to 36months. After baseline measurements, efficacy was assessed by echocardiography and single-photon emission computed tomography (SPECT) (6, 12, and 18months), metabolic equivalents (METs) and maximal oxygen consumption (MVO2) (6 and 18months), and cardiac magnetic resonance imaging (MRI) (6months). We enrolled 21 ADRC-treated and 6 control patients. Liposuction was well-tolerated, ADRCs were successfully prepared, and transendocardial injections were feasible in all patients. No malignant arrhythmias were seen. Adverse events were similar between groups. METs and MVO2 values were preserved over time in ADRC-treated patients but declined significantly in the control group. The difference in the change in MVO2 from baseline to 6 and 18months was significantly better in ADRC-treated patients compared with controls. ADRC-treated patients showed significant improvements in total left ventricular mass by MRI and wall motion score index. SPECT results suggested a reduction in inducible ischemia in ADRC-treated patients up to 18months.

Conclusion
Isolation and transendocardial injection of autologous ADRCs in no-option patients was safe and feasible. Our results suggest that ADRCs may preserve ventricular function, myocardial perfusion, and exercise capacity in these patients.


I just received the full paper and will come back on it after I have gone thru it.

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PRECISE Paper 25 Apr 2014 14:14 #1598

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Actually- through the years I have been at the forefront of the PRECISE and APOLLO studies and I know the published results by "heart" :grin:

Funny thing is, that in 2010 when the PI´s of both studies were planning to present the results at the PACO conference in Madrid in early May 2010, Cytori invited me to come (i.e. would take care of the entrance fee). I however balked at the Madrid hotel prices, after which Tom said that Cytori would pick that one up too.



Big surprise was, after arriving, that my room was upgraded to a super-suite and I had a gigantic thing with CC (as he told me later) camping in a cupboard right next to me. :joy: That was good and the way it should be. Was the only "goody" I ever accepted from them i.e. never asked for anything.

In hindsight- I still think that ADRCs are best suited for the ACUTE scenario in cardiac. MI therefore. But I do realize that the CHF market is much bigger and probably easier to conquer, since hardly anything works.

Whatever- Cytori opted for refractory angina or chronic ischemia- whatever you name it- a patient population that is likely serve VERY WELL with improved blood flow, by reaching hibernating myocardium tissue and putting that tissue back to work, resulting in the statistically improved METS and MVO2 numbers.

I have heaps of slides of that, that nobody has ever seen. That probably will stay that way, since most of them I cannot tie in to the numbers that I have read in the scientific paper that is ready for print in one of the AHA journals.

Those numbers however -

ARE NOT NEW NUMBERS- SIMPLY a repeat of what has been published before

As stated in the abstract- After baseline measurements, efficacy was assessed by echocardiography and single-photon emission computed tomography (SPECT) (6, 12, and 18months), metabolic equivalents (METs) and maximal oxygen consumption (MVO2) (6 and 18months), and cardiac magnetic resonance imaging (MRI) (6months). -so no measurements seem to be made at 36 months- not even the mortality data presented in the paper are based on 18 months, which surprises me pretty much. :whistle:

Anyway- conclusion- nothing new- but vital for certain market powers to have SCIENTIFIC BACK-UP of the science.

Just weird again from Cytori management (unbelievable really) to put this on any list of PPS moving events. :cry: :cry:
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PRECISE Paper 25 Apr 2014 14:50 #1599

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So- in order for you to judge yourselves- below are the metrics from the patient population which I cannot tie in-

NOTE: the treated population for some weird unknown reason is 10 (TEN) years older as placebo. All LVEFs are lower than I thought they were.. :KO:




And following is the discussion from the paper:

Discussion

In this multicenter, randomized, placebo-controlled, double-blind study, we have shown for the first time that the harvest and transendocardial injection of ADRCs is safe and feasible in no option patients with ischemic cardiomyopathy. Moreover, cell therapy with ADRCs in these patients may preserve functional capacity over time and could exert a modest beneficial effect on myocardial perfusion, scar size, and left ventricular contractility.
Adipose tissue comprises a mixed cell source containing a high proportion of MSCs. The stromal fraction has been shown to contain multipotent stem cells. Our approach allowed us to isolate ADRCs in high numbers in real time (under 2 hours), during which time baseline mapping procedures were initiated in patients in preparation for cell injections. ADRCs, unlike other cell types such as hematopoietic cells, have no specific cell surface markers. Thus, we used stromal-associated and stem cell-associated markers in our flow cytometric analysis and confirmed that the SVF comprises a heterogeneous cell population. The SVF cell population contained low-to-medium levels of cells positive for the mesenchymal marker CD105, as previously shown, as well as low-to-medium levels of cells with endothelial (CD34 and CD31) and hematopoietic (CD45) markers. Although the percentage of CD34+ cells in the SVF varies, we found a strong positivity for CD34+ cells. In contrast, CD45+ cells were scarce, as previously reported. Our data on cell phenotype should be interpreted cautiously because the SVF is not a homogeneous population, and the final composition can be affected by the methods used to harvest ADRCs and perform flow cytometry. The use of automatic rather than manual isolation may have contributed to our low percentage of CD105+ cells. Finally, the mesenchymal proliferative capacity (CFU-F) of ADRCs in our study supports that reported by Dromard and colleagues.
In the present study, we provide preliminary evidence that harvesting ADRCs and delivering them by transendocardial injection is safe in patients with advanced CAD. No major safety issues were noted, specifically regarding cardiac arrhythmias and clinical adverse events.
The safety profile appears to be comparable to that of delivering bone marrow–derived mononuclear cells, and the logistics are suitable for a point-of-care, same-day injection model.
The rates of death were similar in our study to those reported in the largest registry of no-option patients. We reported 2 cardiac deaths at 18 months (7.4%), for a total mortality of 18.5%.
MVO2 levels were preserved in the ADRC-treated group at 6 and 18 months as compared with the natural progression of the disease seen in the control group (in whom MVO2 levels progressed toward eligibility levels for heart transplantation). This finding is interesting, considering that patients received only a single treatment with ADRCs over an 18-month period.
Moreover, studies show that MVO2 has significant prognostic value in patients with severe heart failure and that directional changes in MVO2 over time have prognostic significance. We believe that monitoring changes in MVO2 levels may be more meaningful than evaluating LVEF in patients with chronic heart failure.
Our results are comparable to those of previous studies with bone marrow-derived cells and MSCs in no-option patients. Both Losordo’s1 and Haack-Sorenson’s groups also showed the safety of transendocardial injections and improvement in exercise tolerance as well as quality of life scores in these patients. However, in contrast to MSCs, ADRCs in our study did not reduce scar size or increase LVEF but instead appeared to result in scar stabilization. This may indicate different mechanisms of actions between the 2 cell types.
Recent studies have shown a reduction of scar size after infusion of cardiac stem cells in the subacute and chronic phases of MI. Considering that our patients were in advanced phases of ischemic heart disease, a left ventricular mass increase of 21g and the maintenance of scar size after ADRC injection suggest a beneficial response to cell therapy in these patients.
Although mechanistic study of ADRCs is beyond the scope of this study, we could hypothesize that ADRCs have cardiogenic and angiogenic paracrine effects. Accordingly, a recent report showed that ADRC therapeutic function is induced primarily by paracrine-mediated cardioprotection and angiogenesis. Improvements in perfusion and left ventricular mass may support these hypotheses, but confirmation in a larger study is warranted.
This study has several limitations. The small sample size limits the statistical rigor of our findings and our efficacy conclusions. Because baseline MRI and SPECT measurements varied between the 2 groups, imaging results should be interpreted cautiously and considered as hypothesis-generating. However, the double-blind nature of the study and the use of a blind core reading of efficacy measures avoid biases in endpoint assessments. Furthermore, medication use, which is the most important factor that can influence clinical course in these patients, was similar between groups. Age was also significantly different; the treatment group was older, which may
have biased them toward a worse outcome. Furthermore, a 3:1 randomization scheme resulted in a smaller control group, thus reducing the power of the study. Finally, MRI data were available only at baseline and 6 months, precluding longer follow-up.
Conclusion
Our findings indicate that obtaining autologous ADRCs via liposuction and delivering them by transendocardial injection is safe and feasible in patients with ischemic cardiomyopathy.
Moreover, our trial provides a sound basis for testing the efficacy of ADRC therapy in a larger group of patients with chronic myocardial ischemia.
Conflict of Interest: Dr. Perin currently receives consulting fees from Cytori Therapeutics, Inc,
and his wife, Jacqueline Perin, is currently employed by Cytori but was not at the time of the
study.[/b]

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PRECISE Paper 25 Apr 2014 15:54 #1600

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Just weird again from Cytori management (unbelievable really) to put this on any list of PPS moving events

It's moved the pps alright only in the wrong direction. Based on the actions of the management team and the inability to follow through on any of it's promises or guidance to shareholders does it really surprise you. The data is way over my head so perhaps you can discuss is laymans terms. My question to you Fas is this. You have always been a supporter of what will go on at Okeynos when they start treating patients. It is my understanding that the procedures discussed in the Precise trials will be used to treat patients in the Bahamas. Would you clarify. If the data is no big deal to you ( and I may be interpreting that incorrectly,or "read it wrong)" Why so positive on why Okeynos results will benifit Cytori or is it other procedures they will be doing using other methods that excites you. Would you please set me straight.

Is this it ?

In hindsight- I still think that ADRCs are best suited for the ACUTE scenario in cardiac. MI therefore. But I do realize that the CHF market is much bigger and probably easier to conquer, since hardly anything works.

Whatever- Cytori opted for refractory angina or chronic ischemia- whatever you name it- a patient population that is likely serve VERY WELL with improved blood flow, by reaching hibernating myocardium tissue and putting that tissue back to work, resulting in the statistically improved METS and MVO2 numbers

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PRECISE Paper 25 Apr 2014 20:24 #1601

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There was a need for ATHENA 2 and I still am NOT satisfied with the spin for it. :bang: :KO:

I agree with the acute cardiac (MI) event side Fas....but they went with chronic and even JK was Poo-pooing acute treatments at one point thinking "off the shelf" would like better serve this population. How and why I never heard on his conclusion at the time....other than he thought the treatment time factor was a issue.

Forgeting cardiac and the sad aventures into breast, cosmetic and your favorite Fas, fistula...the best starting point on this therapy was likely auto-immune. It is amazing how a group of managers can consistantly make so many wrong decisions ! :evil: :puke: :evil: :bash:

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PRECISE Paper 26 Apr 2014 09:23 #1602

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Michael-

Yes- this line is the reason- a patient population that is likely served VERY WELL with improved blood flow, by reaching hibernating myocardium tissue and putting that tissue back to work, resulting in the statistically (significantly) improved METS and MVO2 numbers

Okyanos and Cytori Cell Therapy can help stop the death spiral for patients slowly but surely sliding into the irreversible CHF conditions and put them on "hold" if you like.



It will not cure them - but extend their lives considerably and its quality.

And on top of that- I think we are at stage 1 - if you like- the procedure can be improved in the future by exposure to growth factors making the impact of cells much more considerable.
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PRECISE Paper 26 Apr 2014 10:11 #1603

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Forgeting cardiac and the sad aventures into breast, cosmetic and your favorite Fas, fistula...the best starting point on this therapy was likely auto-immune. It is amazing how a group of managers can consistantly make so many wrong decisions ! :evil: :puke: :evil: :bash:


:really: LOL- my fistula after Crohns I regard as perfect for the tech-




Basically covers the immune side and wound healing properties, which include blood flow.

But the BASIC thing about ADRCs and the Caplan theories WHICH ARE VALID AND GREAT INFO FOR THOSE THAT LISTEN TO HEDRICK & Co.- Pericytes respond to acute injury, where ever it occurs so by definition are most suited for acute versus chronic.
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PRECISE Paper 26 Apr 2014 19:44 #1604

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*** LOL- my fistula after Crohns I regard as perfect for the tech-***

No doubt but the appilcation is in purgatory.

To bring up the point once stated by rongside that after exploring all the wrong roads all that was left was the correct one...and that was kinda where I was going with the statement....and I am still wondering where the next 18 months gets us that will be reflected in the PPS.

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PRECISE Paper 27 Apr 2014 10:17 #1605

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No doubt but the application is in purgatory.


Thanks Hedge- you increased my vocabulary with one interesting word.

But I do not agree there- to me it is impossible that a solution for an unmet need is dead or semi-dead. Time will tell. :whistle:

As some might know- I had a Adobe Dreamweaver based Young-foxes.com site- followed by a Dreamweaver Cytx-investor.com site, before switching to the final CMS (Joomla) product that you are looking at now-

So plenty of content- also from the past- legislation is also an option, which apparently I was considering in 2011. This was what I wrote in that time frame-

Cytori´s reporting to shareholders- a case for the SEC??
I presume the primary duty of the management of a Company is to provide sufficient information about the developments within the Company, be it revenue, regulatory or technological development in order to be able to assess the future value of the unit. Especially in the last category I believe Cytori to be highly deficient.

The Fistula case

In June 2010, as written about many times, CYTX received EMA added claims on Celution for the application Fistulas after Crohns disease without ever mentioning on which clinical data the approval was based and all analysts (and private shareholder) questions have been basically ignored by Hedrick by providing stories "as answers", which bear no relation period to the questions involved. A perianal (as rectal-or vaginal) fistula is an abnormal connection, a type of abscess, between the perianal space and outside skin surface. Its treatment has absolutely nothing to do with the microvascular wound healing Hedrick is always referring to, but ADRCs act by controlling reduction of inflammation in the fistula, promoting adequate homeostasis through the release of anti-inflammatory factors which in turn promote natural fistula closure. Interestingly enough, recently (June 2011) - Cellerix, the only EU (spanish) competition, which have been doing clinical trials on the indication since 2002, terminated its Phase III trial called FATT with autologeous cultured ADRCs, since it "became apparent that the protocol was not reflective of clinical reality". Another reason for "OPENING UP" on this, since there obviously is a lot of shareholder value here, which they to date have refused to share.

Other applications in development

About two years ago, Hedrick answered an analyst question on the first treatment of a patient with acute renal failure. Hedrick mentioned- the patient was fine, but it was too early to report upon. Since than- nothing has been heard. There obviously has been a change in thinking (as so many times- mainly to the detrement of the shareholder)- in 2008/9 three videos came out with interviews of doctors and patients, who were the first to be treated for a new application (Radiation wounds, Heart failure and SUI), which were excellent examples of the width of the platform technology. Nothing followed- although two small clinics on liver cirrhosis were done. Plenty of stuff on CLI (as we learned above) and other apps, which a reliable "grapevine" is reporting upon. Three years ago Cytori started a collaboration with Fraunhofer in Germany investigating ADRCs in ischemic stroke. Where does that stand????

Clearly - the weaknesses of CYTX as a Company without approved (reimbursable) products are its inability to generate meaningful revenues and a management that has proven sustained incompetency. Its strenght lies in the technology and the incredible potency of ADRCs.

So -where should the focus be????

One could say, that failure to promote its strenght is a case for the SEC, since it destroyes shareholder value. On the other side, you dont pick feathers from a naked chicken- so that doesnt make sense right now. But it might make sense going forward under certain conditions
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