My story is your story.

Eventually we all reach that moment in life when have to face our fears.

Did you know a moose will hide behind a tree when it senses danger? The moose figures if it can’t see you, you can’t see it.

I hid behind a tree as well, when I began to feel symptoms of heart disease. We all hide.  Perhaps I was naive, based on the fact that there was no history of heart disease in my family. Perhaps it was the overriding attitude that I was invincible to the issues that plague mankind.

Like the moose, I hid behind the knowledge that three of my grandparents lived into their nineties, eating pretty much anything they wanted.

However, deep down I knew something was wrong. I had symptoms. I could jog but had to walk the first mile. I had pains in my jaw and neck, my blood pressure was high and my weight gain was unprecedented—classic angina. My family doctor felt medication was the best solution, despite no diagnosis of blocked arteries (yet.) I began to blame my angina symptoms on the medication and stopped taking them. I started lying to my wife about my blood pressure readings at night. Finally, I could not continue hiding from the truth. I went to a cardiologist and it was determined that I had four major blockages in my heart.

I faced my fears on March 23, 2011; open heart surgery at the age of forty. I was no longer the exception but now a statistic. I was now a part of a new club, with millions of members: the “zipper club“!

I used the experience as an opportunity to transform my life. I had spent years avoiding lightning and buses when the biggest threat to my health was twenty feet from my sofa—my refrigerator. I completely dismantled my entire nutritional pyramid and flipped it upside down.  Plants became my foundation and everything else was replaced. That simple decision produced enormous results. By simply having a plan, I was now in control of my disease.

I realize that my heart disease will not simply disappear, and in the years to come there will be new obstacles to navigate. For now I have relieved my symptoms. Through surgery I have bought some time that I can use to fortify my body and mind for the next fight.

I embrace the future and in particular the technology that comes with it. I reached out to the Okyanos Heart Institute because their treatment offers time to the patient grasping for it. I am drawn to the fact their procedure uses our own cells to heal from within. Each and every day I strive to assist my cells in becoming healthier and to provide my body with the tools it needs.  Stem cell therapy is yet another tool and, when combined with a healthy lifestyle, it can promote longevity.

Majority of us will face the challenge of fighting for our years in later life, and it comes down to a simple question. Do you want to spend your last years in a gradual state of decline, mentally and physically?  Or do you want to challenge the odds and finish up on your feet?

There are always options.  Never stop looking for them.

About the Author:  Ian Welch

In 2011, at the age of 40, Ian underwent quadruple bypass surgery. By adopting a plant-based approach to wellness, he has completely transformed his life. His goal is to provide others with a plan of action when faced with difficult circumstances.

Ian lives in Palm Beach Gardens, Florida, with his wife. His day job involves managing municipal bond portfolios. He is an avid long distance runner & Bikram Yoga practitioner, and his blog can be accessed at http://wholefed.org/.

Ian recently published, Instead of Flowers: Harness the Power of a Chronic Disease.

No-option cardiac patients typically are diagnosed with chronic coronary artery disease and can no longer be revascularized using conventional therapy of angioplasty/stent or bypass surgery. The longevity and quality of life of these patients are uncertain if their condition cannot be improved. The current treatments for patients who cannot be revascularized with standard care are limited to medication, transmyocardial laser revascularization (TMR) and/or enhanced external counterpulsation (EECP), and heart transplant.

Okyanos offers a new treatment to the “no-option” patient using the delivery of adipose-derived stem and regenerative  cells (ADRCs) to the heart.  The ADRCs assist the heart to repair tissue that is either wounded by a heart attack or diseased. The most important observation made by researchers has been that a certain type of stem cell, called a mesenchymal stem cell, grows new blood vessels in the heart, known as angiogenesis. The new blood vessels have been shown to support and improve heart function.

To date, nearly 1,000 patients have been treated in clinical trials with “mesenchymal” cells after heart attacks or with chronic coronary artery disease. The sum of these results have shown strong signs of efficacy and the more recent trials with more advanced cell mixtures and improved isolation methods, such as ADRCs, have shown better results than the first generation of trials.

You can learn more about cardiac stem cell therapy for chronic coronary artery disease and our vision at Okyanos, by watching this video where I discuss it in more detail.

In 2001, Doctors Emerson Perin and James Willerson were the principle investigators on the first stem cell therapy trial for chronic coronary artery disease. Since that trial nearly 11 years ago, aging effects have been observed on bone marrow stem cells (BMCs). It appears that BMCs become less effectual with age.

The doctors further detail in their article the fact that bone marrow stem cells weaken in the presence of disease in the host, making them less potentially effective for the use of cell therapy in treating heart disease.

Patients should not be disheartened by these findings. Perin and Willerson also discuss other potential options to overcoming these bone marrow issues, and highlight adipose (fat-derived) stem cells as already having shown safe and encouraging results among patients with coronary artery disease.

Further, according to their research, it appears that certain bodily tissues are more resilient than others—as you, perhaps, may have personally experienced in your own stubborn waist line. Even in the presence of multiple physical diseases and aging, a patient may be able to gain weight easily. This demonstrates that the stem cell content and potential of fat tissue is less affected by disease and aging as bone marrow is.

Interestingly, both patient groups showed significant reductions in previous heart attack scar damage upon injection of the cells. Further, promising improvements were made in heart function during a 6-minute walk test. Overall, many patients reported improved quality of life from the treatment.

The stem cells that are derived from fat (adipose tissue) are a mixed population, including a high count of mesenchymal cells as well as several other cell types that grow new blood vessels and reduce inflammation. It is extremely encouraging to have yet another trial show resultant support for both cardiac cell therapy as a treatment option and of the use adipose-derived stem and regenerative cells (ADRCs) as a cell-type for this treatment.

Question: What excites you about this new cardiac cell therapy treatment as an experienced nurse?

Gretchen: I’ve been in critical care nursing since 1983 and most of the patients in my care were in intensive care units- recovering from heart attacks, stent procedures, and even open-heart surgery. I have witnessed many advances in cardiac care over the years, but I’ve never been more excited and optimistic to be a part of a new standard of care in treating chronic heart patients, many with no-other available treatment options, using adult stem cells from a patients own body fat to improve the quality of life for qualified patients.

Question: What can patients expect from patient care at Okyanos?

Gretchen: The patients treated at Okyanos can expect the same or even better quality standard of care that they would receive at a hospital in the United States. The nurses that will be taking care of our patients, including myself, will be with those patients every step of the way. From the minute they arrive into the pre-op area till they complete their initial recovery and are safely released to their families, we will have an experienced nurse with the patient. All of our nurses are specially trained in the care of cardiac patients.  At Okyanos, we adhere to the highest standards of practice as established by the American Operating Room Nurses (AORN) that sets the standards and protocol for all of operating room nursing and the American Association of Critical Care Nurses (AACN) for cardiac nursing and intensive care nursing.

The Okyanos patient care team is led by interventional cardiologist, Howard Walpole, MD, our Chief Medical Officer. Dr. Walpole, with more than 25 years of practice, is a highly regarded cardiologist in the United States and currently serves as trustee of the American College of Cardiology. Under Dr. Walpole’s leadership, Okyanos has also established a Medical Advisory Council consisting of leading cardiologists with more than a decade of stem cell research experience. To summarize, our patients are cared for by our experienced nursing team, treated in our first-in-class cardiac cell therapy treatment center of excellence, by some of the most experienced cardiology and adult stem-cell physicians in the world.

Question: What are the most frequently asked patient care questions that you receive about using a patient’s own stem and regenerative cells as part of this new treatment option for patients with chronic heart disease?

Gretchen: The biggest question would have to do with safety. Patients, understandably so, want to know the stem cell procedure is safe. It is actually a very safe procedure, as safe as having a stent placed or having an angioplasty done. It’s not a big, scary procedure, like an open-heart type surgery.

Patients will often ask, will they be awake during the procedure? We sedate our patients to keep them comfortable, but they will be awake and pain-free, especially during the cardiac catheterization procedure. Throughout the entire procedure, the nurses and the cardiologist communicate with our patients, making sure they are comfortable.

Questions about the recovery process are also very typical. The most common question: what it will be like and when they can expect to be feeling better?  We explain to our patients that as far as the day of the procedure, they will receive a comprehensive recovery examination, and if fully recovered, will be released to their family and the comfort of their recovery room. Typically, patients will be able to walk around the day of the procedure and normally by the next day will be fully mobile and feeling better than before they went into the operating room.

As far as the relief of symptoms goes, I’ve heard different things from different patients, but most report improved quality of life from the stem cell implantation in almost five weeks. Originally, we were thinking that it might be up to three months to experience a relief of symptoms commonly associated with heart disease, but the reports that we’re getting, some patients are experiencing improvement in as early as four to five weeks. The Okyanos treatment is a minimally invasive procedure using your own adult stem cells, with negligible risk of infection, and a fast return to normal daily activities for an overall better quality of life.

About Gretchen Dezelick, RN, BSN, CNOR, LHCRM

As the director of nursing, Gretchen Dezelick oversees all of the clinical operations and maintains the superior cleanliness and safety standards that make Okyanos Heart Institute a center of excellence.

With more than 25 years of nursing experience progressing from bedside nursing to administrative and management positions in a variety of healthcare settings, Gretchen was a Certified Critical Care Nurse (CCRN) for more than 20 years and has been a Certified Peri-Operative Nurse (CNOR) for three years.

Question:  Matt, you and your brother Joe had the vision for Okyanos Heart Institute; share that journey with us.

Matt Feshbach:  My brother Joe and I were collaborating and sharing research on a number of investments and we came across the discovery that stem cells resided in a person’s own body fat (adipose tissue).  We became very intrigued with the concept of what these adult stem cells could do and the more we learned about it, the more focused we became on conditions that lacked blood flow (ischemic) or conversely benefited from new blood supply. We ultimately focused on cardiac, because coronary artery disease (CAD) is the biggest killer in the Western world and has been for 100 years.  More people die from CAD than all cancers combined.  So that is how we conceptionally came to our vision of Okyanos from our research process of a public company.

In February 2011, my brother and I attended a meeting called Cell Society where we became real believers with the data reported from the PRECISE clinical trial. In this trial, a patient’s own adult stem and regenerative cells were harvested from their adipose (fat) tissue to treat damaged areas of the heart and the reported results were significant and sustained for 18 months. This was a breakthrough in cardiovascular medicine. We imagined treating patients from the US in an English speaking country would be a very big opportunity for patients and their family, and for us to create value in a business.

After the Cell Society meeting, Joe and I started exploring if we could create such a cardiac cell therapy center of excellence. On August 2nd we raised the capital for Okyanos Heart Institute and unfortunately on August 12th, my brother Joe passed away from a sudden cardiac arrest.  Losing my brother, further motivated me to help as many people, as soon as possible, that suffer from coronary artery disease.  Okyanos, personally, enables me to help others and honor the memory of my brother.

As most people know, every leader needs a great team. So, I began to research the most experienced cardiologists in the United States and that’s how I discovered Dr. Howard Walpole, an interventional cardiologist with more than 25 years experience and currently serving as the Trustee of the American College of Cardiology.  I’m delighted that Dr. Walpole is now our full-time Chief Medical Officer at Okyanos Heart Institute.

In addition, we were able to recruit a Director of Nursing, Gretchen Dezelick who has more than 25 years of experience as a Director of Nursing and Patient Safety Officer in various clinical settings, including cath labs and cardiology clinics. So, between Gretchen and Dr. Walpole, we have a great patient care team.

To run our organization, we’ve brought in experienced healthcare leaders, starting with Erika Mangrum, our Senior Vice President of Marketing and Lester Morales our Vice President of Corporate Development. Both have many years of educating patients and physicians on specific innovative medical procedures. In addition, Manuel Vianna, a partner, has deep expertise in international business as well as finance and technology. I am proud that we have ended up with a very strong team with a lot of mutual respect for each of our individual skills and experience and a determination to help patients suffering from heart disease.

After reading this post, we invite you to contact Okyanos with your questions.

Question:  What is a patient registry?

Dr. Walpole:  A patient registry is a database of information organized by certain criteria for a given disease state.  This data enables a physician to evaluate a patient before they are treated and helps dictate how to follow the patient after treatment.  Collectively, all of the data can be structured into specific data fields and further analyzed in a larger population.  This presents a unique opportunity to learn things about treatment plans and disease states that perhaps were not previously known.

Question:  What are some of the more frequently asked questions from patients about the Okyanos Heart Institute patient registry process?

Dr. Walpole:  Ultimately, Okyanos helps patients with chronic ischemic heart disease that have no further coronary artery option for treatment of symptoms of congestive heart failure and ischemia.

The most frequently asked questions are:

• What can I expect after being treated? 
• How soon can I expect to see improvement in my symptoms?
• What kind of follow up will be required?
• How will the treatment effect the medications that I currently take for heart failure?
• Am I going to live longer as a result of this treatment? 

Certainly, these are all very important questions that will arise and can only be answered on an individual basis.

Question:  What’s the best way for people to discover if they or a loved one may be a candidate for cardiac cell therapy and Okyanos treatment?

Dr. Walpole:  The best way is to contact our office and allow our medical personnel to gather necessary information from prospective patients.  This information, along with information from their cardiologist, is used to determine if they are a candidate for treatment or if additional testing is required.  With such innovative medical technology as stem cell therapy, many clinicians may not be fully aware of the latest inclusion criteria for treatment.

If you have a question about cardiac cell therapy that you’d like me to answer in another blog post featuring your question, please leave in the comment section below.

For any personal medical history questions, please contact Okyanos Heart Institute at Toll Free 1.855.659.2667 and one of our medical professionals will be happy to assist you.

As an interventional cardiologist, I am excited to see a meta-analysis of trials using adult bone marrow stem cells (BMCs) for the treatment of coronary artery disease for both post-heart attack and patients with chronic CAD. This post reviews promising cardiac studies with bone marrow highlighting the significant potential of this relatively new approach, namely using cells, to treat ischemic disease.

The conclusions in this study are very supportive of the Okyanos cardiac cell therapy treatment and the use of fat (adipose) derived stem cells given their superior accessibility, abundance, and potency. Adipose (fat) tissue contains a different mix of cells, relative to bone marrow, which could carry an even greater impact supporting the repair of damaged heart tissue as the result of lack of blood flow (ischemia).

Cardiac Cell Therapy (BMCs) Trials Summary:

Cardiac cell therapy trials using adult bone marrow cells (BMC) were the subject of a large meta-analysis that showed that transplantation in patients with ischemic heart disease offers lasting improvements in key cardiac metrics compared with conventional therapy alone. The study, published online June 22, 2012, ahead of print in Circulation, also indicates that clinical outcomes are improved with this treatment.

Key study findings are:

• Meta-analysis finds lasting improvement in LV function, infarct size, remodeling with bone marrow cell therapy for ischemic heart disease
• Signs of clinical benefit
• Results support initiation of large, randomized trials

Researchers led by Buddhadeb Dawn, MD, of the University of Kansas Medical Center and Hospital (Kansas City, KS), analyzed 50 studies including 36 randomized controlled trials and 14 cohort studies) that were identified by database studies through January 2012. The studies involved 2,625 patients who either experienced a heart attack or had chronic ischemic heart disease.

Compared with standard treatment, BMC transplantation resulted in improvements in mean LVEF, infarct size, LV end-systolic volume, and LV end-diastolic volume (table 1).

The effect on LVEF persisted for at least 24 months after transplantation, while the improvements in the other cardiac parameters lasted for at least 12 months.

Substantial benefits were also seen in several clinical outcomes, including all-cause mortality, cardiac mortality, recurrent MI, and stent thrombosis (table 2).

Table 1. Cardiac Parameters: BMC Transplantation vs. Standard Therapy

Table 2. Clinical Outcomes: BMC Transplantation vs. Standard Therapy

In addition, strong trends emerged toward decreased risk of heart failure and cerebrovascular events. Safety measures including in-stent restenosis, TVR, and ventricular arrhythmias were similar between BMC therapy and controls

The authors acknowledge that the increase in LVEF imparted by BMC therapy is relatively small. On the other hand, the improvement in post infarct remodeling may translate into superior long-term prognosis, they say. The mechanisms behind the reduction in infarct size and remodeling benefits remain poorly understood but could be due to enhanced angiogenesis and reduction in programmed cell death.

Dr. Dawn stressed that the survival benefit seen in this analysis is a critical basis for beginning large randomized trials of BMC transplantation, and the durability of positive effects add to the existing knowledge base on this topic. “It has been suggested that the effects of bone marrow cell therapy are short lasting,” he said. “[But] our results from pooled data show that these effects generally persist for longer periods.”

Another key finding is that benefits appear greater in patients who received bone marrow mononuclear cells than in those who received specific bone marrow subfractions, Dr. Dawn added.

As with any meta-analysis, the reliability of results from a pooled group of studies can be debated. For example, there were significant differences with regard to imaging modalities used, timing and route of cell injection, and population characteristics. Still, the strong overall results favored BMC transplantation and led them to conclude more study is warranted.

Study Details:

Studies ranged in size from 10 to 391 patients, with a median sample size of 39 patients. Follow-up varied from 3 to 60 months, with a median duration of 6 months. Timing of transplantation in acute MI patients ranged from 1 day to 18.4 days, with a median delay of 6.7 days. All of the cohort studies and at least 15 of the randomized controlled trials failed to blind participants or the caregivers involved.

Source:

Jeevanantham V, Butler M, Saad A, et al. Adult bone marrow cell therapy improves survival and induces long-term improvement in cardiac parameters: A systematic review and meta-analysis. Circulation. 2012;Epub ahead of print.

*A meta-analysis is a systematic method of evaluating statistical data based on results of several or more independent studies of the same problem.

“The people really at risk are the ones who have obesity in combination with other metabolic health risk factors,” said Mark Hamer, a principal research associate at University College London who worked on the study.

Metabolic health is defined as having normal levels of markers like blood pressure, blood sugar, HDL, or “good” cholesterol, and C-reactive protein, which is a measure of inflammation in the body. People with good metabolic health did not appear to be at increased risk of heart disease, regardless of body weight. On the other hand, non-obese people with poor metabolic health suffered the same risk as their unhealthy obese counterparts.

These findings are helpful for purposes of stratifying patient’s risks and making recommendations on diet, exercise and medical therapy. It is important to remember that weight loss alone will not necessarily reduce ones risk of heart disease. Weight loss can be an effective method for control of blood pressure, blood sugar and elevated cholesterol levels. Risk factor modification is multi-factorial and is an important component of any heart disease treatment strategy. Patients should discuss their risk factor profile with their doctor and follow the guidelines established by the American College of Cardiology and the American Heart Association.

Of particular note was the presentation of the FOCUS-CCTRN trial results at the opening session by Emerson Perin, M.D., Ph.D., director of clinical research for cardiovascular medicine at the Texas Heart Institute’s (THI) Stem Cell Therapy Center. This was a phase 2 randomized, double-blind, placebo-controlled trial of symptomatic patients (New York Heart Association classification II-III or Canadian Cardiovascular Society classification II-IV) with a left ventricular ejection fraction of 45% or less, a perfusion defect by single-photon emission tomography (SPECT), and coronary artery disease not amenable to revascularization who were receiving maximal medical therapy at five National Heart, Lung, and Blood Institute–sponsored Cardiovascular Cell Therapy Research Network (CCTRN) sites between April 29, 2009, and April 18, 2011. Among patients with chronic ischemic heart failure, transendocardial injection of autologous BMCs compared with placebo did not improve LVESV, maximal oxygen consumption, or reversibility on SPECT.

Despite these results, Dr. Perin, who was one of the study’s lead investigators, was pleased with the study’s design and its contribution to the ongoing study of stem cells. “This is exactly the kind of information we need to move forward with the clinical use of stem cell therapy,” he said.

“The bone-marrow derived stem cells are helpful to the injured heart when they are themselves biologically active,” added Dr. James T. Willerson, the study’s principal investigator and president and medical director of THI. “This study moves us one step closer to being able to help patients with severe heart failure who have no other alternatives.”

The study was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), the national consortium to conduct such research funded by the National Institutes of Health’s (NIH) National Heart, Lung, and Blood Institute (NHLBI).

“It’s no longer a question whether the bone marrow cells work or don’t work; they do work when you have healthy stem cells,” said Dr. Willerson in an interview. “The search now is to find the very best stem cell type or types. And at the moment, I’d say the best stem cells are fat-derived cells and stem cells that reside in the heart called c-KIT positive stem cells.” He  later presented findings of his latest research at one of the ACC annual scientific sessions.

Texas Heart Institute also sponsored a review session which included discussions on stem cell therapy for acute MI and peripheral vascular disease. The beneficial effects of mesenchymal cells for treatment of heart failure and C34+ cells for coronary ischemia were also discussed.

Dr. William Roberts and the American Journal of Cardiology hosted an Editor’s Roundtable discussion on stem cell therapy in heart disease. I had the pleasure of participating as a panelist with Dr. Joshua Hare from the University of Miami, Dr. James Willerson from Texas Heart Institute and Dr. Leslie Miller from the University of South Florida. The discussion centered around the advances in cell therapy and the impact of that science on how we treat heart disease. This discussion will be available through the American Journal of Cardiology and the Okyanos Heart Institute website.