Finally this week, a rather strange story coming out of Ireland. Western European nations are usually the last places that you'd expect to find Doctor's providing unlicensed treatments out of their clinic but it's been going on here.
In Cork, Ireland a clinic has bene provinding unlicensed stem cell treatment for suffers of Multiple Sclerosis. The treatment(?) involves injecting stem cells into the body to supposedly repair damaged cells in the brain.
The treatment is provided by a Swiss Boitech firm through one clinic and the matter has now reached desk of the Minister of Health who is said to be looking into the treatment for which patients ar being charged up to US$50,000.
Whilst many stem cell therapies are experimental, there is a big difference between those which are carried out with approval of the relevent authorities and those which are conducted illicitly.
TheraVitae released the following Press Release regarding Dr. Valentin Fulga, TheraVitae's Co-Founder and CEO, invitation to speak at the inaugaural Israel Innovation Summit to be held in April 2006.
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World Economic Forum Technology Pioneer in Stem Cell Research Invited to Speak at Israel Innovation Summit 2006 Dr. Valentin Fulga, CEO of the TheraVitae Group, the producer of VesCell™ -- Adult Stem Cell Therapy for Heart Disease, has been invited to speak at the inaugural Israel Innovation Summit 2006. The Summit will be held on 4-5 April at the Haifa Congress Center, Haifa, Israel. The World Economic Forum recently named Dr. Fulga as one of its 2006 Technology Pioneers for his work in adult stem cell therapy.
Haifa, Israel (PRWEB) March 29, 2006 -- Dr. Valentin Fulga, Co-Founder and CEO of TheraVitae, has been invited to speak at the inaugural Israel Innovation Summit 2006. This groundbreaking summit brings together leading researchers, entrepreneurs and venture capitalists from Israel and abroad; all committed to a common goal of striving to discover the breakthrough technologies and treatments of tomorrow.
The Summit is the first of its kind in Israel and will accelerate innovation through the sharing of knowledge, collaborations, and investments. World-class researchers from leading universities will explore their applied activities and unveil future technologies, making it an ideal networking platform. Commenting on his invitation to speak during the two day conference, Dr. Fulga stated, “It is an honor to have this opportunity to present our adult stem cell technology and its vast potential at this distinguished meeting. We are delighted that the organizers regard TheraVitae as a leading innovator and have chosen to include us amongst the select group of companies attending the Summit.”
Joining Dr. Fulga for the round table session on Cell and Gene Therapy, chaired by Dr. Nissim Darvish, a Partner in Pitango Venture Capital are:
- Prof. Dror Harats, M.D., Head, Institute of Lipid & Atherosclerosis Research, Haim Seba Medical Center at Tel Hashomer and CEO, Vascular Biogenics, - Dr. Shulamit Levenberg, Biomedical Engineering Department, Technion - Prof. Raymond Kaempfer, CSO, Atox Bio Ltd. Faculty of Medicine, The Hebrew University of Jerusalem
On the heels of his recognition as one of the World Economic Forum’s Technology Pioneers for 2006, and in the wake of the growing success of VesCell, TheraVitae’s proprietary adult stem cell therapy for heart disease which has now been used to treat over 100 patients including famed Hawaiian entertainer Don Ho, Dr. Fulga remarked, “More and more patients are being successfully treated with our therapy every day. Consequently, our technology is gaining an increasing amount of recognition in the scientific and medical communities. This bolsters our confidence in developing additional therapies for other severe disorders, such as critical limb ischemia.
About The Israel Innovation Summit (IIS) 2006
On April 4-5, 2006 an inspiring international gathering of academia, start ups, entrepreneurs, emerging companies, NASDAQ stars and global corporations will meet for The Israel Innovation Summit, at the Haifa Congress Center, Israel.
The first conference of its kind in Israel, the Israel Innovation Summit offers a look into the future in Cell and Gene Therapy, Distributed Computing, Nano Electronics and more. The Summit will act as a meeting platform where breakthrough technology will be introduced and discussed by leading experts, corporate investors and venture capitalists from around the world.
World class keynote speakers -- from the US, Europe and Israel -- will make presentations, including CEOs and Senior Vice Presidents of multinational leading companies. Top researchers will present their visions for the new frontiers of technology which are ready for implementation. Panel discussions with Israeli public companies and global leading corporations will also take place.
It's not only the US where funding for stem cell research is a hottopic of discussion. In Europe, Germany, Austria and other nations opposed to European Union funding of human embryonic stem cell research proposed an EU funding ban this month in Brussels at a meeting of the EU's 25 national science ministers, raising concerns that the minority group could force nations to remove this funding from the newest budget, even for scientists in countries where the research is legal.
This means they could halt enactment of the EU's next science funding program for 2007-13, known as Framework Programme 7 (FP7), unless wording is added to the final FP7 document that would ban EU funding of human embryonic stem cell research.
Under the current Framework Programme 6 (FP6) guidelines, the EU gives funding priority to human adult stem cell research and will not fund any research on embryonic stem cells conducted in member states that forbid the research.
Under FP6, eight projects involving human embryonic stem cell research have been funded and nearly 100 involving human adult stem cells have received funding approval.
The majority of doctors still beleive that unless they can actually see accurately measureable improvements in heart function then any improvement resulting from a patient receiving adult stem cell therapy for heart disease is more of a feel good factor than medical effect.
Additionally, the number of stem cells required for any treatment to be effective is debatable. If only there was a scientific way to measure the effect that implanted stem cells had on heart function. Researchers at Cordis, a subsidiary of Johnson & Johnson, is paving the way for the pioneers to both accurately deliver stem cells via catheter and also measure the effectiveness through advanced 3-D imaging of the heart.
Cordis has developed two breakthrough products.
The NOGA(R) Cardiac Navigation System is the most advanced technology currently vailable on the market to create highly precise, three-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could benefit from a variety of targeted therapies.
The MYOSTAR(TM) Injection Catheter is not yet commercially available in the United States and is used only under investigational protocols.
What better way to start the week than with news from a patient who's seen his EF double since undergoing VesCell therapy in mid-2005, and who now regards his health as back to 'almost normal'. This email was sent by Richard S. to TheraVitae's Co-Founder Don Margolis. Names have been abbreviated to ensure patient and doctor confidentiality.
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From: "Richard S." To: dm@theravitae.com Sent: Thursday, March 23, 2006 10:51 PM Subject: Richard S. Progress Report
Dear Don,
Sorry we haven't been in touch sooner, but we have been monitoring your progress on the blog and it appears that you are snowed under in Bangkok with new patients.
It sounds like you are doing a great job with TheraVitae. . .more power to you. Buddha must be looking after you.
Medical update is good. I'm getting good reports from my cardiologist and you know how nasty they are.
My 8 July '05 Echo showed a 15% EF. The left ventricular systolic function was severely depressed with an ejection fraction of 15%. The anterior wall and inferior wall were akinetic. There was severe hypokinesis of septum and lateral wall was severely hypokinetic. There was mild left ventricular hypertrophy.
My 6 January '06 Echo showed the left ventricular systolic function was moderately depressed with an ejection fraction of 30%. There was mild hypokinesis of inferior wall. There was no evidence of left ventricular hypertrophy.
In comparing the two tests, I think you will agree with my cardiologist and Dr. P. that my heart function has improved substantially. I also got good news yesterday (22 March) on my recent CXR that my heart silhouette is normal and there is no infusion or edema of fluid. Compared this with an 25 August '05 chest x-ray, where the heart silhouette showed mild enlargement.
I guess the overall conclusion is that the stem cells are working and my health is heading in the right direction and I'm almost normal which would be scary!
Paul Harvey, widely known as the largest one-man network in the world and American News' 'Voice of the new millenium' recently featured TheraVitae on his daily news roundup.
Mr Harvey, a recipient of the highest civilian honour in the USA, The Presidential Medal of Honour, has been in radio for over 60 years and his daily news round-up is syndicated, via ABC, to over 1,200 radio stations, 400 Armed Forces Network stations around the world and 300 newspapers.
On Wednesday, March 22nd Paul Harvey featured TheraVitae on his 'Noon News' show. A transcript of the broadcast commentary is below:
Tiny bubbles!
When Hawaiian singer Don Ho sought help for his ailing heart he was in his 70’s at least. Too old to be eligible for a transplant, but too much in love with life to lie down and die. So he heard of stem cell research which promised to rejuvenate ailing hearts, to rejuvenate heart muscle with injections of stem cells culled from the patient’s own blood.
But that’s a procedure not allowed in the United States, where stem cell research is limited by religious constraint. So the corporation which was able to proceed with and benefit from stem cell research was and is the TheraVitae Company with offices in Thailand and has laboratories in Israel.
Don Ho determined to struggle through the international red tape secured the procedure for himself, is stronger by day, is returning to work. The doctor who established the Theravitae Company is an American doctor. But he was not allowed to offer his procedure in the United States, so he moved to Bangkok, Thailand. And its there he has established a worldwide research and corporate facility while establishing laboratories in Israel and lab specimens are then flown to Bangkok for implant and frustrated physicians in the US who dare not risk prosecution and can’t afford to flee are secretly applauding those who do.
(Hear the original audio broadcast on VesCell.com )
All of us at TheraVitae are extremely grateful for Mr Harvey helping get the word out about stem cell therapies for heart disease patients that are available now. However, we'd like to clarify a couple of points in the broadcast:
1) TheraVitae is a Thai / Israeli company. Dr. Amit Patel, a well-known, highly regarded American Cardiologist and specialist in the field of adult stem cell therapy has worked with us in a supervisory role, but he is not, as the transcript mentions, a founder of the company. That honour belongs to co-founders, American entrepreneur Don Margolis and eminent Israeli scientist Dr. Valentin Fulga.
2) TheraVitae's laboratories and research team are located in Israel, whilst treatment takes place in Bangkok, Thailand - taking advantage of the world-class medical facilities that are available at specialised centres such as Bangkok Heart Hospital.
3) We thank Mr Harvey for his kind comments on the unspoken support of doctors, however, we can't comment on individual cases such as Don Ho's without the patient's consent. But from our experience the results of stem cell therapy have surprised the most ardent of critics. Even the most overwhelming improvement in a patient's quality of life isn't measurable scientifically, but MRI scans don't lie.
If you had to select one country as the heart of stem cell research, which would you choose. It would need to be somewhere well known for scientific research. The UK? Germany? Somewhere, with a forward thinking goverment that encourages all types of stem cell research South Korea? Netherlands? Plus there would obviously have to be an environment that attracts entrepreneurs and pioneering types? USA? Sweden?
Arguably, the best way to determine which country can lay claim to being the world's 'stem cell research centre' is to look at the number of research articles published in scientific and medical journals in proportion to the population of the country.
In 3rd place . . . Switzerland
2nd . . . Sweden
and No 1 is Israel . . . a country which also happens to be home to TheraVitae's research team. It looks like they're keeping good company.
TheraVitae, yesterday, issued the following press release on the progress shown by Marie Carty, a patient who prior to reveiving stem cell therapy last year was on the transplant list. Nowadays, a heart transplant simply isn't an option for Ms Carty.
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“Stem cells changed my life” -- Heart patient says transplant 'not an option' after her condition dramatically improved following stem cell therapy.
Little Silver, NJ (PRWEB) March 21, 2006 -- New Jersey native, Marie Carty, knew she needed a new heart. Heart disease had robbed her of any chance of ever leading a normal life again and her cardiologist had no option other than to recommend evaluation for a heart transplant. However, Ms. Carty refused to accept the status quo and instead turned to the Internet for help. Several months later she flew half way around the world in order to receive VesCell™, a pioneering adult stem cell treatment, at Bangkok Heart Hospital.
Before receiving treatment in Thailand, Dr. Mark Zucker, Director of Heart Failure and Transplantation at Newark Beth Israel Medical Center, New Jersey, had recommended that Ms. Carty undergo evaluation for a heart transplant. “Can’t do this,” she replied.
Ms. Carty’s health had been failing badly in the run-up to receiving the experimental treatment. Her morning walks along the New Jersey shore had long been replaced with entire days spent lying listless in front of the television.
While many patients may feel wary of traveling abroad to receive any medical care, let alone one involving such an advanced treatment as adult stem cell therapy, Ms. Carty simply says, “I literally had no option other than to pray I would receive a transplant in time. I became determined to find an alternative. Then I found TheraVitae, the Israeli-Thai biotech company who developed VesCell, on the Internet. Their treatment required minimally invasive surgery and, as you’re treated using cells from your own blood, there seemed to be no chance of complications due to rejection. To be honest, at this stage in my life, I realized I had nothing to lose and everything to gain.”
Just a few months after her treatment, Ms. Carty recollects, “I knew I felt great, the change was like night and day. I had more energy, more stamina and even resumed my occasional two mile walks; something I hadn’t done for a long time. But to hear my own doctor say, "Do you realize that your heart is beating three times -- pumping three times--the amount of blood than before?” was nothing short of amazing. All I ever hoped for was to be able to lead a normal life again and that’s what I’m doing now.”
Ms. Carty, whose story was recently featured on the Christian Broadcast Network television show, The 700 Club, joins legendary Hawaiian crooner Don Ho and a growing number of patients worldwide who have reported life-changing results after undergoing VesCell therapy in Thailand.
Ms. Carty’s treatment involved her giving a half-pint of blood (similar to a common blood donation), from which her adult stem cells were harvested and then differentiated and expanded in-vitro at TheraVitae’s laboratories in Israel. The resulting cells were then implanted directly into her heart by cardiac surgeons at Bangkok Heart Hospital. The total cost for her two-week stay in Bangkok including the life-altering procedure was around US$35,000; a fraction of a heart transplant’s whopping US$150,000+ price tag.
VesCell therapy has to yet receive the green light from the U.S. Food and Drug Administration; so for now, ‘no-option’ heart patients will have to continue traveling to Thailand in order to receive this potentially lifesaving treatment. Other medical teams around the world also report promising results in the treatment of chronic heart disease using adult stem cells. However, these treatments, unlike TheraVitae’s simpler, less painful method, use stem cells derived from bone marrow, rather than blood.
On hearing the news of Ms. Carty’s dramatic improvement in heart function, Don Margolis, Co-Founder of TheraVitae, commented, “Nothing amazes me any more. Marie’s story is only one of the many successes that we have seen in patients treated using VesCell therapy. Our patients want their voices to be heard and want other people to have the opportunity to undergo the same life enhancing treatment that they received. Their message is loud and clear ‘Today, TheraVitae can offer affordable, safe and effective treatment for ‘no-option’ heart disease patients.’”
Today's article is a heart warming story that I've added to the blog for a couple of reasons:
Firstly, it involves a seriously ill patient who received stem cell therapy almost 3 years ago, made a successful recovery and is now living a normal life.
Secondly, it reminds us that when the term 'adult stem cells' is used it relates to stem cells taken from a living human's body rather than an embryo. Regardless of the age of the human donor - baby or adult.
And, thirdly, it serves as yet an other example of how 'adult' stem cells can be used to save lives, something that much touted embryonic stem cells have yet to be used to do in humans.
Read the full New Straits Times article and discover how little Angel Lai, a child whose doctors only gave a 10% chance of survival, is now a healthy, happy 4 year old thanks to a stem cell donation from her baby brother.
A very important event which indirectly affects anyone suffering from heart disease took place last week. This year's annual American College of Cardiologists Scientific Session included a new summit entitled ' i2 Summit 2006: Innovation in Intervention'.
The i2 Summit provided participants with a forum to discus key innovations such as:
• Late-Breaking Interventional Clinical Trials • Peripheral, Vascular & Coronary Interventions • Live Cases from Europe, Asia and the United States • Emerging Technologies
Participants included cardiologists, radiologists, cardiovascular and vascular surgeons, vascular specialists, scientists and clinical trialists.
The online press room contains information on the topics discussed during the 3-day meet which took place from 12-14 March. The following links to downloadable pdfs of press releases covering topics discussed and abstracts from research findings may be of interest to anyone considering stem cell therapy.
Marie Carty made the headlines in newsppaers around the world a couple of month's ago when they ran a syndicated article on her treatment using VesCell therapy and subsequent recovery which was put out on Associated Press newswires.
Marie was making news again recently when she appeared on the Christian Broadcast Network's popular '700 Club' TV show. ( Read the full text of the article on Marie here. )
Recent episodes of the '700 Club' are avaiable as streaming video. The March 15th show included a segment on Marie, her treatment and progress to date.
Follow this link to visit the show summary page. Then select the video icon for the 15 March show which features Dr. Michael Roizen discussing what viewers can do to maintain their cardiovascular health, to view the show online. (Marie's segment appears around 15 minutes into the show.)
Less than one month ago, TheraVitae treated it's first Israeli patient - a small step but a significant one for an Israeli-Thai company.
Whilst is still early days, we have recevied the following email from the patient who wanted to share his story with others who may be comtemplating undergoing VesCell therapy. We'll be posting quarterly updates on the patients condition so that readers of this blog can learn first hand of any improvements in heart function and the patient's overall quality of life.
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Six months ago I began a journey in search of an alternative treatment to address slow but constant deterioration in my heart condition. This journey consisted of intense research and investigation, a sometimes hesitant resolve to move forward as planned, unequivocal support and encouragement from my family, skeptical questions from my friends, support from members of the attending medical team in Israel and a personal relationship established with Theravitae staff in Israel headed by Dr. Valentin Fulga.
Today I begin a new stage in that journey: successful long-term recovery from the Thoracoscopic injection of the Theravitae Vescell™ Stem Cell Pack therapy administered very professionally at the Bangkok Heart Hospital by Drs. Kitipan Visudharom, Permyos Ruengskalrach, Pradub Sukhum, and Sudaratana Tansuphaswadikul on February 20th, 2006. Granted -- by all medical standards it is still very early. There is still much work in progress before I successfully reach the minimal 3-6-9-12 scheduled quarterly ergonometric follow-up checkpoints. I return home filled with optimism that the end results will meet my expectations: improve the quality of my life, reduce the risks inherent in my heart condition and perhaps even postpone or avoid the need for a heart transplant.
My confidence and inherent optimism paid off every step of the way: I found professional and caring support from my friends Dr. Valentin Fulga and Mr. Don Margolis in Theravitae management, all members of the BangkokHospital medical staff and the local operations teams. My plan is to strengthen this relationship and continue to work closely to further promote the potential benefits of these efforts for myself and others wherever possible.
The Chicago Sun Times has an interesting article on additional research into benefits that could be derived from injections of stem cells into a patient's circulatory system in the hope that they find their way to the heart and help heal damaged areas. You'll remember a German study recently showed that mobilising stem cells into the bloodstream and expecting that they would home in of the affected areas of the heart didn't have a high sucess rate.
The difference in this new study, being undertaken at 16 medical centres, including Rush University Medical Centre, will aim to show that stem cells obtained from a healthy donor can help patients who have suffered a heart attack.
Donor's stem cells are matched with recipient's in order to reduce risk of rejection. It appears that researchers belive that using stem cells froma younger, healthier donor may provide positive results. As with the German study,the focus is on providing effective treatment without any form of surgery being required.
As most readers of this blog will know, Dr. Amit Patel is one of the world's foremost experts on the treatment of heart disease using adult stem cells. We, at TheraVitae are therefore honoured and privileged to have Dr. Patel work with us in supervisory role on a regular basis.
You will have read about Dr. Patel in many articles both online and in print. However, have you ever heard him speak? Unless you have been fortunate to attend seminars or events where Dr. Patel has been invited to speak, the answer is probably 'No'.
Recently, the Heart Surgery forum recently carried an audio interview with Dr. Patel, a 2.5MB file, in which you can hear him talking about the future of stem cell therapy for the heart and upcoming trials.
Taking a break from stories out of the USA, here's a glimpse at how one team of researchers in Malaysia are working to treat heart patients using adult stem cells.
Reading the article, you immedaitely notice that the method is very similar to the one that was recently discredited by German scientists. However, there is a big difference, stem cells are induced out of the bone marrow and into the bloodstream, but they are then harvested from periperhal blood and injected directly into the affected area.
The obvious question that needs to be asked is how do the scientists avoid injecting stem cells that could cause calcification into the heart? (As these stem cells are undifferentiated and all will not automatically become heart muscle or capillary cells.) The article mentions that the stem cells are preppared after harvesting to avoid clotting but no mention of any differentiation between type of stem cells is made.
A thought provoking story that leaves you marvelling at the work some scinetists and researchers are undertaking presently, to end the week. This is taken from the Wisconsin Technology Network which reports on news of a discovery at the University of Wisconsin-Madison by researchers at the Materials Research Science and Engineering Center.
Apparently, LCDs - the same devices that are used in the screens on your mobile phone, notebook computer, Gameboy or flat screen TV can actually be used to report in rela time on the differentiation of stem cells. Differentiation is the process by which stem cells gradually turn into function-specific types of adult cells e.g. skin, heart or brain cells.
The process works as differentiated cells exert different levels of force on the matrix (i.e. support/scaffold) in which they are grown. That force can be read to a liquid crystal. Through simple changes of liquid crystal texture and color, the cell culture system is able to report, in real time, the cell interactions with the underlying support on which they are grown.
So read a recent headline in the Pittsburgh Business Times. Will Pittsburgh become a hub of stem cell research? It will if the McGowan Institute for Regenerative Medicine has its way, as it is apparently close to bringing three adult stem cell companies, from Ohio, Israel and South America to Pittsburgh. The driving force behind this move is Dr Amir Patel, Director of Cardiac Cell Therapy at the McGowan Institute who confimred that the three companies were all ones he currently works with.
Pittsburgh is attractive to the relocation candidates because it was the first city in the country where stem cells were surgically delivered into patients' hearts. With the companies convinced at a clinical and scientific level to relocate to Pittsburgh, only the financial aspect, including incentives from state and local governments, still need to be ironed out before the companies will agree to come, according to Dr Patel.
In response to the recent negative headlines regarding stem cell therapies for heart disease patients, TheraVitae yesterday issued the following press release in order to clarify the situation and set patients' minds at ease.
Heart disease patients should not be discouraged by a recent report titled “Stem Cell Treatment for Heart Attack Ineffective" published recently by leading news sources, describing an unsuccessful clinical trial for the treatment of heart disease.
March 7, 2006 -- In this report, German researchers concluded that a specific therapy with a growth factor called ‘granulocyte colony-stimulating factor’ (GCSF) bringing the body's bone marrow stem cells into the circulation, did not appear to be effective. It is important to stress that the doctors did not use stem cells, but a well-known molecule used in cancer patients to recruit stem cells from the bone marrow. Contrary to the accurate title originally presented by the publishing scientific journal ("Stem Cell Mobilization by Granulocyte Colony-Stimulating Factor in Patients With Acute Myocardial Infarction"), it was erroneously described by public media, incorrectly directing the focus towards stem cell treatment.
Some experts believe that the G-CSF method might not have been effective because it failed to deliver the right cells to the right place - the key to any effective treatment.
When asked his opinion on the G-CSF results, Dr. Amit N. Patel, Director of Cardiac Stem Cell Therapies at the McGowan Institute for Regenerative Medicine (University of Pittsburgh Medical Center) replied, “Cell therapy is still in its infancy. No one knows why adult stem cells work. At this early stage, mobilizing cells systemically and hoping they’ll know where to go and what to do is simply unrealistic. The most effective way to treat patients is by administering the cells directly into the organ.”
A key aspect of VesCell™ therapy, developed by TheraVitae to treat patients suffering from end-stage heart disease, is the advanced cell isolation and expansion technique that allows for the effective use of specific stem cells harvested from blood. These resulting cells are then directly administered to the specific target areas in the heart.
Dr. Yael Porat, Vice President for R&D at TheraVitae, said: "A substantial difference exists between the treatment of heart disease using a molecule administered systemically and cell therapy. Compared to the massive amount of diverse cells that are nonspecifically mobilized from the bone marrow using G-CSF, VesCell™ consists of a purer, well-characterized and controlled progenitor cell population which has been purposely cultured to exert a beneficial effect in the heart. Furthermore, the cells are specifically “educated” to induce a healing process within the diseased areas of the heart into which they are directly injected. It is the interaction between the injected cells and the patient’s own body, among other factors, that probably lead to their beneficial effect. It is extremely important to clarify these points so that patients retain hope of improving their condition.
"Nearly 100 patients have so far been successfully treated using VesCell™. The latest success story for TheraVitae was the treatment of Ohio lawyer, Harry DePeitro, whose cardiac MRI scans showed an increase in pumping ability of almost 20% after receiving VesCell™ therapy. Others include Dee Coats, the first Californian to receive VesCell™ therapy; Jeanine Lewis, a patient suffering from Class III-IV heart failure whose doctors reclassified her as a Class I patient only 3 months after she received VesCell treatment and Marie Carty, a New Jersey woman whose successful treatment was recently reported on by several leading news agencies.”
“Unsubstantiated headlines may grab readers’ attention but they do little to further understanding of the highly complex world of adult stem cell therapy.” That’s the opinion of Mr. Don Margolis, Founder of TheraVitae. “TheraVitae will continue to focus on providing its adult stem cell therapy to patients with no other therapeutic option. The increasing experience obtained from the treatment of more and more patients enhances our confidence in the positive outcome of Vescell™ and its benefit to patients with end stage heart disease.”
On 6 March, MSNBC ran an article from Business Week Online regarding research into adult stem cell therapies for heart disease patients. They writer took the positive view that although recent German cast doubt on the effectiveness of one such treatments this does not mean all relatated treatments should be tarred with the same brush. A couple of methods of treatment are discussed in the article.
One therapy that isn't mentioned, but possibly should have been as it's effectiveness has been proven numerous times, is one that has been used to successfully treat almost 90 patients and has even resulted in a patient being removed from the heart transplant list 3 months after treatment. This is of course VesCell herapy from TheraVitae.
Heart, Heal Thyself?
The dream of medical science is to train the body to repair itself in the face of disease or trauma, and the main focus of this dream is the heart. For five years, teams of doctors around the world have been trying to coax adult stem cells, the body's innate repair kit, to regenerate damaged heart tissue after a heart attack or other coronary disease.
These efforts have generated excitement among heart specialists, despite the fact that clinical trial results have been uneven and no one is quite sure how, why, or even if, stem cell therapy works. The excitement continues to mount, despite a study released on Mar. 1 stating that one of the most widely examined methods for delivering stem cells to the heart had failed.
A team of German doctors from Technische Universitat in Munich reported on a rigorously conducted trial in the Journal of American Medical Association [JAMA). Scientists injected G-CSF, a human growth factor known to stimulate adult stem cells, within 12 hours after a heart attack.
There were 114 patients in the study, more participants than the three earlier G-CSF trials combined. Half received the treatment, and the other half were given a placebo. After six months of follow-up, the researchers discovered that G-CSF did prod a significant number of stem cells to move from the bone marrow, where they are produced, to the heart, with no serious side effects.
Nonetheless, there was no improvement in heart function, throwing doubt on the whole stem cell approach. "The answer is fairly unequivocal," says Dr. Kenneth Chien, director of the cardiovascular research center at Massachusetts General Hospital in Boston. "The stem cells did not improve function."
Unequivocal or not, the failure of the German trial has not dampened enthusiasm for heart regeneration. Several reports on stem cell research will be highlighted at the American College of Cardiology meeting in Atlanta on Mar. 11-14, and teams of doctors and biotech companies around the world are continuing their research in this area.
Most are quick to point out that their methods are fundamentally different from the German approach. If anything, the failure of G-CSF turned more attention on the many efforts to deliver stem cells directly to the heart, rather than indirectly trying to stimulate them with a growth factor.
There have been no human studies of the direct approach on the scale of the German trial, and the many smaller studies have often been contradictory. But even Chien, who considers himself a conservative when it comes to stem cell therapy, says it is one of the more exciting areas of heart research. "I don't think it should be considered a slam dunk, but I do think it is promising long-term."
Stem cell researchers, many of whom also treat patients, are driven by a huge unmet need. Some 1.1 million Americans are struck by heart attacks each year, and 4.8 million suffer from congestive heart failure, in which the heart stops pumping effectively, with 400,000 new cases diagnosed each year.
Both these conditions are caused by the destruction of heart muscle cells, and there are few effective therapies that can counteract that damage. Unlike most other tissues in the body, the heart does not regenerate itself. When damage occurs, it merely grows scar tissue, which restricts pumping even further.
Stem cells seem like an obvious solution. In an embryo, stem cells, which are undefined, can turn into any tissue in the body.
Because of restrictions and ethical concerns about the use of embryonic stem cells, however, most heart experiments involve adult stem cells extracted from the bone marrow. The pioneers in this area are Drs. James T. Willerson and Emerson C. Perin of the Texas Heart Institute at St. Luke's Hospital in Houston.
In 2000, Willerson and Perin treated 14 Brazilian patients with stem cells removed from their hip bones and directly injected with a catheter to their damaged hearts. Within two months, the patients demonstrated improved heart function, with almost double the pumping motion in those parts where the cells were injected.
When one of those patients died 11 months after treatment, of unrelated causes, the doctors discovered during an autopsy that there was clear evidence of new blood vessel formation to the heart.
The team is now conducting a U.S. trial with 25 patients, and recently won approval for another trial. "We realize that we've not identified the best stem cells, or the best method of administration," says Willerson. "We don't want to be part of the hype, but this is an exciting time."
Willerson and Perin are using the patient's own adult stem cells to avoid rejection by the body's immune system. But a small biotech in Baltimore, Osiris Therapeutics, is aiming to come up with a more universal approach by using donated mesenchymal stem cells [MSC].
These are universal to everyone, so they do not set off an immune reaction. Animal studies indicate that the MSCs are prompted by inflammatory signals to head to the site of an injury, and Osiris recently started a Food & Drug Administration-sanctioned clinical trial to test the therapy in heart attack patients.
Then there are stem cells that actually originate in the heart, discovered only two years ago. These cardiac stem cells exist in very small numbers, but doctors at Johns Hopkins School of Medicine have figured out how to harvest them by taking a small tissue sample from the heart and then growing them in culture.
The cells have not yet been tested in humans, but when injected into animals they appear to go straight to the heart and regenerate tissue, says Dr. Eduardo Marban, chief of cardiology at Johns Hopkins. "The mystery is: If these cells do work to heal the heart, how do they work?" questions Marban. "We're reading the first page of a very long book here."
Long it may be, but Marban speculates that there could be evidence of whether or not adult stem cells work in humans in a year or two. It will certainly take longer to figure out why. There are many scientists in the field who believe the stem cells may be merely "good neighbors" that are prompting the heart's own healing process to kick into high gear.
That wouldn't be such a bad discovery, says Dr. David T. Scadden, co-director of Harvard University's Stem Cell Institute. "In the short term the stem cells may be providing something that reverses damage, but that could lead to a whole new generation of studies into an off-the-shelf drug that would perform the same function." In that dreamscape, heart attack victims could just visit the pharmacy instead of the hospital.
More unfortunate news coming out of South Korea as investigators dig deeper into the various claims of successful biotech treatments.
The real story of a South Korean woman who walked again following stem cell treatment on her damaged spine is far removed from headlines such as 'Stem-Cell Gal's Miracle Steps' (New York Post, Nov.2004). Any improvement the treatment had was only fleeting and Hwang Si Moo is still confined to a wheelchair.
In hindsight the relaxation of regulations due to the collective stem cell euphoria that pervaded South Korea wasn't a prudent long term. The work of discredited scientist Hwang Woo Suk led to dozens of other companies offering everything from cancer treatments to anti-aging potions. Treatments which now appear not to be as successful as first assumed.
It should be noted that far from providing unproven treatments, TheraVitae offer stem cell therapies that have been shown to work time after time. New patients are encouraged to talk to others who've already received VesCell therapy and can give real examples of the improvement in quality of life they've experienced.
The headline grabs the attention but the reality is that the experimental treamtent is still at the animal testing stage. However, results have been very promising.
An article in the March 1, 2006 issue of Cancer Research reported on an animal study in which bone-marrow derived neural stem cells and a newly discovered cytokine* worked synergistically to track and kill glioma cells and offer long-term protection. However, researchers at Cedar Sinai Medical Center, Los Angeles who undertook the stufy are very optimistic about the potential for treatment in humans.
“The paper recapitulates our previous data demonstrating that the neural stem cells – in this case from bone marrow – were able to track to the tumor very efficiently and, like a heat-seeking missile, deliver a killer depot,” said John S. Yu, M.D., neurosurgeon, co-director of the Comprehensive Brain Tumor Program at the Maxine Dunitz Neurosurgical Institute, and the article’s senior author. “We obtained the stem cells from bone marrow, mirroring what we want to do clinically, which is to take bone marrow cells from a patient, make them into neural stem cells, put in the gene of interest and treat the patient.”
[*A cytokine is atype of protein that is released by cells of the immune system and act as intercellular mediators in the generation of an immune response.]
The article below, authored by Dr. Grant Morrow, Medical Director of the Columbus Children's Research Institute at Children's Hospital is a useful primer for anyone visiting this blog for the first time and who requires a brief overview of the diffrences between embryonic and adult stem cells. One glaring omission, however, is the simple fact that adult stem cells can also be harvested from a patient's own blood in addition to bone marrow.
Human stem cells have unique characteristics. For one, they are unspecialized in the sense that they don't perform a specific function in the body until they are stimulated to change. For example, cells that help the heart beat or produce insulin.
This ability gives them enormous potential to treat diseases. One might characterize the fertilized egg as the ultimate stem cell because it eventually differentiates into a complete human being.
There are two types of stem cells - embryonic and adult.
Embryonic stem cells are present at the fourth to fifth day after fertilization. Because these cells can divide and renew themselves in the laboratory for a long time, they can be grown in large enough numbers to treat a variety of diseases. They also have the greatest potential to differentiate into various types of specialized cells.
Adult stem cells, on the other hand, are located in various organs and help maintain and repair them.
Adult stem cells, however, cannot renew themselves as much in the laboratory and do not have the potential to differentiate into other cells as completely as embryonic stem cells.
In the 1960s, researchers discovered that adult bone marrow contained stem cells that could differentiate into any blood-cell type of the body. As a result, bone-marrow transplants have become effective, standard treatment in many patients with cancer.
However, obtaining bone marrow stem cells requires matching donor and patient and performing an operation to obtain the bone marrow.
Blood from a newborn's umbilical cord contains large numbers of stem cells that can be used as an alternative source. Cord cells act as adult rather than embryonic stem cells.
Since cord blood is routinely discarded, its use for transplantation should minimize ethical concerns.
Researchers have compared the use of bone marrow versus cord blood cells to treat cancer and found that both approaches were equally effective.
A major advantage of cord stem cells is that they can be grown in the laboratory, and matched and stored for future use.
Solving the technical and ethical issues regarding the use of stem cells will require more research, but the discovery that cord blood can be one additional source of adult stem cells is a major advance.
How we harness and use the greater potential of embryonic stem cells is an issue that will require time to resolve.
Yesterday Theravitae issued the following press release regarding the progress of one of our patients, Mr Harry DePietro.
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Comparisons of pre- and post-operative ejection fraction (EF%) tests show significant improvement in Ohio man’s heart function following successful adult stem cell treatment in Bangkok, Thailand.
Youngstown, OH (PRWEB) February 28, 2006 -- For years, Harry DePeitro, 51, suffered from the debilitating effects of cardiomyopathy and coronary artery disease. However, five months after undergoing pioneering stem cell therapy in Thailand, his life has taken a dramatic turn for the better. Mr. DePeitro was treated at Bangkok Heart Hospital using his own stem cells derived from a simple, painless ½-pint blood donation.
Cardiac MRI test results prior to his treatment showed an Ejection Fraction (EF) of 26%. Three months after treatment, a post-operative cardiac MRI showed an improved EF of 31% - a 20% increase in the pumping ability of Mr. DePeitro’s heart.
Mr. DePeitro, a lawyer from Girard, Ohio, made the decision to undergo VesCell™ adult stem cell therapy from TheraVitae after his cardiologists informed him that he had no hope of recovery using standard heart disease treatments. “I was in a pretty bad way; I had applied for Total Disability, was hopelessly waiting for what seemed forever for a response to my application, and could barely walk a block without feeling pain in my chest. To be frank, I’d stopped making any plans as I as just waiting for the inevitable to happen.”
He follows in the footsteps of an ever increasing number of ‘no option’ heart patients, including celebrated Hawaiian entertainer, Don Ho, who have undergone VesCell therapy in order to improve their quality of life. In Mr. DePeitro’s case, the reasons were simple, “It was VesCell or give up on any of the plans for my retirement I had when I was younger. How could my life be over at only 50 years of age? That wasn’t something I could come to terms with. The guys at TheraVitae offered me a lifeline.”
In the five months since being treated, Mr. DePeitro has seen his quality of life improve dramatically. “I feel rejuvenated! While I’m not about to enter a marathon just yet, I feel as though I’ve caught a break. Until you’ve lived with the fear that everyday may be your last, you’ll never know just how good it feels to wake up and make plans for tomorrow.”
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