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TOPIC: Bioheart- Angel study

Bioheart- Angel study 16 Oct 2014 11:54 #2465

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Bioheart and its remnants (I hope this does not happen to Cytori) are still active.

This week they did some reporting on their Angel study with fat cells. As some of you know they have a liaison with Hospital Angeles in Tijchuna in Mexico, where several small studies are done. This study is open label (i.e. not blinded in any way) and was only 5 patients although that is not mentioned anywhere.
They have (or had) a cooperation with TissueGenesis where they could use the TG1200 extraction device for cardiac purposes...

Sunrise, FL – October 13, 2014 – Bioheart, Inc. (BHRT.OB), a biotechnology company focused on the discovery, development and, subject to United States regulatory approval, commercialization of autologous cell therapies for the treatment of degenerative diseases, released today preliminary 12 month data from its phase I ANGEL Trial. Fully funded by Bioheart, the trial is being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).
At the 12 month time point, patients are demonstrating a statistically significant average improvement in ejection fraction (EF) by echocardiogram. At the 3 month time point, 100% of the patients demonstrated either improvement or stayed the same. After 3 months, patients showed an average absolute improvement of 3 percentage points in EF. The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p=0.01) and at the 12 month follow up patients showed this same level of improvement (p=0.01).
"This preliminary data shows the potential for this therapy to benefit patients suffering from congestive heart failure," said Kristin Comella, Bioheart's Chief Science Officer. "We are looking forward to expanding this trial to include more clinical sites and patients."
This phase I study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell™) in patients with congestive heart failure. Endpoints include 2 safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.


Interesting where the statistical significance comes from with 5 patients and no placebo to compare to. :whistle: :whistle:

Anyway- ADRCs work- I know that.

Perhaps the best thing is to unblind ATHENA and have Okyanos and other clinics do the job in Japan and Europe..... :winky: :grin:

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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:

Bioheart- Angel study 17 Oct 2014 08:54 #2469

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Fas,

It seems that Bioheart is joining the the many stem cell clinics in the U.S. using patient funded studies through an IRB to bring in some revenues. Here is one in Miami, FL for COPD. www.marketwired.com/press-release/Bioheart-Announces-Clinical-Study-for-Chronic-Obstructive-Pulmonary-Disease-OTCQB-BHRT-1902074.htm

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Bioheart- Angel study 17 Oct 2014 12:12 #2473

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Ray- its really difficult to assess what is going on with these "IRB" clinics.

The study has been reviewed and approved by the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS). The ICMS IRB is committed to providing peer review of proposed studies of cell-based medical therapies based upon appropriate clinical translation, patient care and safety.


The ICMS (led by Ricardo Rodriguez) has had meetings with the FDA, where it has been clearly stated that the ICMS can "evaluate" what they want, but have NO authority in the US. So this is very much a grey area. Since I do not mind some adoption in "grey areas" also, I am not gonna get excited about it.

It is what it is. :really:

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Bioheart- Angel study 17 Oct 2014 12:29 #2474

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Fas,

I can tell you that I spoke directly to the CMO of Bioheart, Kristen Comella, after I came across this clinical trial: clinicaltrials.gov/ct2/show/NCT02041000?term=copd+bioheart&rank=1 . I actually was calling about a elderly relative who was in the hospital with an pneumoniae and had been suffering from COPD. If I recall, the out of pocket cost for the treatment in Miami was 7,500usd. The patient got better and I didn't need to follow through but it is clear that Bioheart technology is being used in this clinic and charging patients. I only know about COPD but there are probably other treatments going on. There are many ADRC clinic operating in this manner and, as in the case of Bioheart, most have a set of procedures that they believe keeps them in compliance with the FDA. If you look at recent quarterly revenues from Bioheart, although less than 1,000,000 per quarter, there have been increasing rapidly off a very small base. I haven't done any DD to ascertain whether the revenues are coming from these type of IRB backed clinical trials but my guess is they are. I think we can refer to this situation as Stem Cell Grey Market.

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Bioheart- Angel study 17 Oct 2014 14:17 #2475

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Ray-

Yes- having been in the circles of "SC patients advocates" for sometime, I do know what this relates too.

David Granowsky and James van den Bosch are two names, who I believe have been pretty much involved in the process. I do believe it helps the patients more than it hurts their wallet, so I am kind of receptive to the events.

I do believe the world of ADRCs is going to be big- so plenty of room for all kind of players.

Coming back to Bioheart- they were (I think) a classy operation in the past- also Cytori scientists assured me that their science was OK, but it just did not work (the infamous myoblasts). The boss of Eric Duckers, eminent cardiologist Serruys, did a lot of work for them under the leadership of Howard Leonhardt - picture below-



Anyway- Matt Feshbach can tell you a lot about the Warren Sherman event in New York where Matt made a speech also. Sherman stands for what does not work, but he is/was a very dedicated SC cardiologist working for Bioheart for a long long time.

The Stem Cell Grey Market will grow, whether we like it or not... simply because it works. :winky:
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Bioheart- Angel study 17 Oct 2014 15:16 #2476

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Fas,

Cytori was once part of the Stem Cell Grey Market for a while as you know. They backed off for two reasons: 1) They did not want to piss of the FDA and threaten the road to approvals. and 2) Their price point was too high. (To think instead of going directly to to desktop version they chose to go to the infamous Celution One). With the way the FDA has been sitting on the sidelines as the grey market expands, I wonder now if that decision was wrong.

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Bioheart- Angel study 17 Oct 2014 16:26 #2477

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Ray-

Cytori was once part of the Stem Cell Grey Market for a while as you know.


Yes, yes, yes...

In hindsight - GE healthcare wanting to sell to anybody who cared to pay for lab equipment, was probably the way to go in the US , whilst the Europeans and Asian´s figured out the technology (the impact of ADRCs to the micro system)

Crazy to think that a guy like Tod Malan is now working for Okyanos, but I think thats good- he is undoubtedly best equipped for the job.

Interesting times ahead of us.... :nice:

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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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