Heart patients pace an additional 91 metres in six-minutes during ground-breaking trials

Published September 23rd, 2009 - 06:28 GMT

Millions of patients with Congestive Heart Failure (CHF) could benefit as Bioheart announces positive clinical trial results

US-based company is an investment of a Middle East medical fund from Ascent Technologies

• The MARVEL Clinical Program is designed to assess functional capacity and quality of life in patients with advanced heart failure after receiving an injection of adult muscle stem cell therapy in to their damaged heart muscle.
• The MARVEL clinical trials are set to become a global benchmark study in CHF.
• The six-minute walk distance (6MWD, an established parameter of efficacy utilised in heart failure studies), increased on average by more than 91 metres in cell-treated patients, whereas in the placebo-treated group a decrease of nearly four metres was seen.
• No significant stem cell-related safety concerns have been uncovered.
A Middle East-backed medical research company, Bioheart Inc., suggests that millions of patients suffering from heart disease have good reason to hope for a return to a more active lifestyle.

Bioheart, a company supported by a Middle East medical fund from Ascent Technologies, recently presented Part 1 of its MARVEL Phase II/III clinical trials on congestive heart failure (CHF). The findings suggest that a treated patient can add a distance of more than 90 metres during a six-minute walk.

The data was presented at the annual meeting of the Heart Failure Society of America by Thomas Povsic, MD, Ph.D., Assistant Professor of Medicine at Duke University.

It revealed that patients in MARVEL Part 1, all of whom suffer from chronic heart failure (CHF), and many of whom are also living with diabetes, were randomly assigned to three separate treatment groups*. 

Each injection of adult muscle cells (16 injections per patient) was administered directly into parts of the ventricular wall specifically weakened by scar tissue from previous heart attacks with the Myostar® device (Biologics Delivery Systems, Diamond Head, CA), a catheter with an established record of safety.  The results presented by Dr Povsic were based on analysis of three- and six-month follow-up data from 20 patients.

During the six-month observation period, the most pronounced changes were seen in the cell-treated groups. 

The six-minute walk distance, or 6MWD, an established parameter of efficacy utilised in heart failure studies, one of the primary end points in the trial, increased on average by more than 91 metres in cell-treated patients. Meanwhile, in the placebo-treated group a decrease of nearly four metres was seen.  This suggests that patients with heart failure could return to a more active lifestyle after receiving Bioheart’s treatment. 

In the US, the American Heart Association (AHA) estimates that more that five million people are suffering from heart disease leading to restricted lifestyle, and that 500,000 more are diagnosed with heart failure each year. The related costs were pegged at US$33.2 billion in 2006.

Dr Warren Sherman, the study’s Principal Investigator, said that the MARVEL Program is designed to assess the effects of administering autologous skeletal myoblasts (ASM) on the functional capacity and quality of life in patients with advanced heart failure.   ASM is also known as patient-derived muscle stem cells.

“I see two key results arising from MARVEL trials and consider it a benchmark study in patients with advanced heart conditions,” said Dr Sherman, Director of Stem Cell Research and Regenerative Medicine at the Center for Interventional Vascular Therapy of Columbia University.

“Firstly, the trial results demonstrate the benefits of myoblast implantation on certain patients with CHF. We will be able to further substantiate our clinical impressions during Part 2 of the large, randomised, controlled study which is powered to detect the effects of these cells on meaningful clinical endpoints.”

He advised that the second crucial result to emerge is on the ‘arrhythmia issue’, or abnormal heart rhythms.

“Our study observed that the arrhythmia process is controllable and only a short-term issue. I believe it is time to shift our thinking and be open-minded as to the long-term implications,” Dr Sherman concluded.

The MARVEL research team includes Dr Povsic and Chris O'Connor, MD, Head of Heart Failure at Duke University.

Karl Groth, Ph.D., Chairman and CEO of Bioheart Inc., considered a leader in the realm of cell therapy for heart disease, said that the results go far beyond the initial expectations for the MARVEL trial. 

“The Part 1 results of the MARVEL trial show positive signs during treatment and an improvement in a chronic heart failure patient's ability to walk distances and be active. This means that a patient may well return to a more active lifestyle. 


“We are committed to moving this study forward and to seeing our technology impact on the population affected by chronic heart failure.”

Dr Groth is also Co-Chairman of the Ascent Group, which has two funds focused on investments in medical device, life science and biotechnology, and will soon be raising a third fund.

According to Dr Povsic, the Principal Investigator at the Duke Clinical Research Institute which helped coordinate the trial, the results have immense implications for the design of MARVEL-2 as well as other similar trials.

“The improvements we observed in six-minute walk are clinically meaningful, and this is the first time improvements have been demonstrated in relation to a blinded placebo control group.

“MARVEL-1 is a pilot study, but the findings are encouraging and suggest that additional trials are warranted,” Dr Povsic said, adding that the MARVEL-1 trial was the first truly blinded study of intramyocardial stem cell delivery via a percutaneous approach. 

Revelations of the MARVEL Program, Bioheart’s family of clinical trials:

Part 1 of the Phase II/III clinical trial focuses on the release of an early segment of data which reveals something very important – the improvement in a chronic heart failure patient's ability to walk distances.  This means that the patient can be more active and may well be able to perform their daily activities better.

1. Chronic heart failure is a life-threatening condition in which a patient is virtually a cripple with no alternative but a heart transplant, or premature death.

2. The MARVEL trial uses muscle stem cells from the patient’s leg.  The biopsy is shipped to Bioheart where myoblasts or muscle stem cells are isolated and expanded.

3. The muscle stem cells are cultivated to a sufficient number to inject into the donor patient, where they have proven to develop as heart muscle.

4. The MARVEL study shows a high-potential for efficacy of the myoblast treatment.

5. MARVEL is a two-part study.  Careful evaluation of Part 1 data has directed changes to the design of MARVEL Part 2.  Part 1 proved that the signal for improvement in 6MWD was so pronounced that all are eager to move on to the next part.

* Three treatment groups : 1) 400 million cells, or 2) 800 million cells, or 3) placebo

About Congestive Heart Failure

Congestive heart failure, or CHF, is a debilitating condition that occurs as the heart becomes progressively less able to pump an adequate supply of blood throughout the body resulting in fluid accumulation in the lungs, kidneys and other body tissues. Persons suffering from NYHA Class II or worse heart failure experience high rates of mortality, frequent hospitalization and poor quality of life.

Although medical therapy for CHF is improving, it remains a major debilitating condition. According to the American Heart Association Heart Disease Statistics – 2007 Update, the estimated, total direct and indirect costs of heart failure in the United States in 2006 were approximately US$33.2 billion.  The AHA also estimates there are more than five million heart failure patients in the United States and an additional 500,000 patients are diagnosed with heart failure each year.


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