US Stem Cell Inc (USRM)

[TheHungryHippo]

EXCLUSIVE DD: MUST READ Data Marvel Part 1, & pre-clinical

Dr. Warren Sherman in 2008:
"The MARVEL study has the potential to transform how we will treat congestive heart failure patients in the future. This is an exciting opportunity for study site teams, to fully engage in enrolling patients and be a part of history. Patients we refer for treatment today, or never get a chance to treat in the cath lab, may become our patients tomorrow.

The target population, and the largest component of the heart failure patient population in the U.S., is comprised of patients who have had heart attacks, who have had coronary disease, and who may have undergone percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) to rectify coronary disease and salvage whatever is possible by way of ventricular function. We are looking for a group of patients who have New York Heart Association class II, III or early IV heart failure; patients whose prognosis clearly sets them apart from those who have class I or early II heart failure, and those who have no heart failure.

MARVEL is a randomized, placebo-controlled study of patients with heart failure after a heart attack, with two treatment groups and one placebo group. The two treatment groups will each have a different MyoCell dosing level based on dose-finding data gathered prior to MARVEL. The low-dose group will receive 400 million cells and the high-dose group will receive 800 million cells. The control group will receive injections of a control media (placebo), such that the patients will not know what they received. We are looking to enroll a minimum of 330 patients, evenly distributed between the three groups. Each group will be carefully followed to assess both efficacy and safety.

In the follow-up period their levels of activity will be monitored. The primary efficacy endpoint relates to how they feel and how far they can walk. These are the key elements of what the patients and their physicians are looking for: to feel better and to be more active. Hopefully, in doing so, we will enable them to live longer. (Note: the study is not powered to look at differences in mortality.). At the same time, we are investigating very careful parameters of ventricular function, building on what I had mentioned about EF and the other components that go into it. MARVEL will involve a very meticulous analysis of how various regions of the heart are working

in response to either cell injection or placebo injection over time (at 3, 6 and 12 months). The other very, very important aspect for patients and physicians taking care of them is how we can keep patients out of the hospital. With current therapies, the incidence of admission of patients to the hospital is quite high, especially in those patients with class IV heart failure. This is a burden to all, especially to patients and their families and the healthcare system. In MARVEL, we will monitor the frequency of admissions for heart failure or worsening of heart failure in each treatment group. As a result, we expect the MARVEL trial to provide us with a better clinical handle on the effects of skeletal myoblast therapy than that of any other study undertaken to date.

IN 2011:
The results of our Clinical Trial Marvel Part 1 were published in the American Heart Journal, the prominent peer reviewed medical journal. When compared with placebo, myoblast therapy was associated with sustained (six months) improvements in six minute walk distance of >90 meters, a clinically meaningful improvement. For congestive heart failure patients, this translates into returning to a more active lifestyle and a better quality of life.



Promising Results from Company’s MARVEL Trials on MyoCell
The company recently announced positive clinical results for MyoCell following the first part of its Phase II/III, double-blinded, placebo-controlled clinical trial called MARVEL. Over the 6-month observation period in this trial, the most pronounced changes were seen in the cell-treated groups. The six minute walk distance (6MWD), an established parameter of efficacy utilized in heart failure studies, one of the primary end points in the trial, increased on average by more than 91 meters, or 35%, in cell-treated patients, whereas in the placebo-treated group a decrease of nearly 4 meters was seen. This suggests that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment. No stem cell related safety issues such as arrhythmias, or irregular heartbeat, were observed. An arrhythmia event is disturbing but not serious. In the MARVEL trial pre-treatment with amiodarone enabled patients to avoid arrhythmias.


From a 2015 Powerpoint presentation found on the internet- by former CEO Howard Leonhardt:






















Other Research Related to Myocell:
http://www.zoominfo.com/CachedPage/?archive_id=0&page_id=176407920&page_url=//www.bioheartinc.com/resources.php&page_last_updated=2010-01-07T23:57:31&firstName=Tatsuya&lastName=Shimizu

https://clinicaltrials.gov/ct2/show/NCT00526253?term=bioheart&rank=3

ClinicalTrials.gov Identifier:
NCT00526253
First received: September 6, 2007
Last updated: January 30, 2017
Last verified: January 2017







The Marvel Study was lead by who?

Warren Sherman: Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of regenerative, protective and reconstructive therapies, announces today the appointment of Dr. Warren Sherman as Chief Medical Officer, effective as of 1 November 2014. In this new role, Dr. Sherman will leverage his deep expertise in the cardiovascular and cell therapy fields to support the continued development of Cardio3 BioSciences' product pipeline, both in cell therapies and cardiovascular diseases.

Dr. Christian Homsy, CEO of Cardio3 BioSciences,commented: "We are very pleased to be able to count on Warren Sherman's expertise in clinical application, as well as his renowned scientific outreach for the further development of Cardio3 BioSciences'future projects in regenerative therapies and cardiovascular diseases."

(Only 4 Companies that I know of, that have Heart Failure therapies using stem cells in the entire world)

1. MESO BLAST (Australia)
2. CARDIO3 (Belgium)
3. US STEM CELL INC. (United States)
4. TERUMO (Japan)

(from Cardio 3:)
CHART-2, the Company's second Phase III clinical trial, is intended to assess in the US, the efficacy of C3BS-CQR-1 as a treatment for heart failure of ischemic origin. CHART-2 is designed as a prospective, multi-centre, randomized, sham-controlled, patient-and evaluator-blinded study comparing treatment with C3BS-CQR-1 to a sham treatment. The trial is aimed to recruit a minimum of 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is the Six Minute Walk Test post-procedure, a commonly used index of cardiovascular performance.

Phase II data published in JACC1 showed C3BS-CQR-1 statistically significant improvement of 77m in six-minute walk distance for the treated patients compared to the control group (p<0.01), which represented a 20% improvement for treated patients versus the control group.
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From Marvel:

Results of part one of the MARVEL phase II/III study were previously presented by Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University. In comparison with the placebo group, myoblast therapy was associated with sustained (6 months) improvements in exercise capacity distance of greater than 90 meters, an increase that would be of great importance to patients if replicated in larger studies.

The study's Principal Investigator Warren Sherman, MD, Director of Stem Cell Research and Regenerative Medicine at the Center for Interventional Vascular Therapy of Columbia University Medical Center stated, "We are gratified that the results of this component of the MARVEL Program will be published in the AHJ, a journal of such high caliber and rigorous peer review process. All involved in the design, conduct and analysis of MARVEL are to be commended, especially those involved at the clinical centers. And special praise is due to Tom Povsic, to his colleagues at Duke and, of course, to our colleagues at Bioheart."

Mike Tomas, President and CEO stated, "The publication of this significant clinical data supporting the use of MyoCell in chronic heart failure patients is an exciting milestone for the company. We remain committed to finalizing part two of the MARVEL trial and eventually commercializing the therapy."