We reported initially at the end of 2005 about Adult Stem Cell Therapy for Heart Disease.
Go directly to latest developments in 2009 (major update).
Original Article from 2005 :
Interested in health matters, we regularly scan health news worldwide and in Thailand. We were indeed surprised when we encountered the article below, published in a U.S. newspaper.
'Improvement of California woman stuns her cardiologist one month after receiving stem cell treatment in Bangkok, Thailand. '
It appears a company called TheraVitae is based in Bangkok, Hong Kong and Israel. Adult stem cell therapy is being given in hospital(s) in Bangkok, Thailand. Scanning of the involved websites reveals that at various times Bangkok Hospital, Chaophya Hospital, and Siriraj Hospital are mentioned. We could not find out how many hospitals are actively involved, how many patients have been treated or what the overall results are.
Still, this is one more 'achievement' that puts Thailand clearly on the map as a destination for health care, and possibly also as a destination for 'experimental' or 'end-of-the-road' desperate medicine. This really is an interesting matter. What is also interesting is that this has not really been covered recently in the English-language newspapers in Bangkok.
While this clearly indicates advanced medical developments, it of course also raises some questions. Why is this therapy by this company (the technology was developed outside of Thailand, to be sure) being performed in Bangkok, and not say in more 'developed' countries such as the U.S. or Europe? Is it possible that medical ethical committees (we assume they exist in the more well known Thai hospitals) are more easily convinced to participate in medical 'trials' like this? Is it part of a policy by Thai hospitals to start catering to desperate people, who can not get certain treatments in their own country, and want to try anything, anywhere to stay alive or get healthy again?
That said, since we do have a medical background, and understand the developments in this field of medicine, we know there is a certain group of patients that can potentially benefit from the therapies given by TheraVitae. Time will tell us whether this therapy in its present form is just a temporary step (experimental medicine, to be sure) or will become a major helpful advancement to the benefit of cardiac patients who are not suitable anymore for standard therapies such as bypass heart surgery, PTCA or stenting of the coronary arteries.
This was in response to a press release from eMediaWire :
In response we received this message from Paul Talbot, TheraVitae
Reaction to our article (by Paul Talbot, TheraVitae Ltd.):
You recently published an article ( http://www.thaiwebsites.com /adultstemcell.asp ) that raised several important questions about stem cell therapy in Thailand.
I think the key point of the article is:
" Why is this therapy by this company (the technology was developed outside of Thailand, to be sure) being performed in Bangkok, and not say in more 'developed' countries such as the U.S. or Europe? Is it possible that medical ethical committees (we assume they exist in the more well known Thai hospitals) are more easily convinced to participate in medical 'trials' like this? Is it part of a policy by Thai hospitals to start catering to desperate people, who can not get certain treatments in their own country, and want to try anything, anywhere to stay alive or get healthy again? "
The therapy takes place in Thailand simply because the owner and founder of the company and the company president both live in Bangkok. Additionally, clinical trials of comparable quality can be conducted at much lower cost in Thailand than in other countries such as the US, for instance. Hence, Bangkok is the first place they talked to cardiologists about it.
The company founder, Don Margolis, suffered through the painful death of his wife by cancer and decided to dedicate the rest of his life to finding cures for terminally ill people. In the course of his research he came across adult stem cell treatments for heart disease that were in clinical trials in Brazil and Uruguay. Margolis became interested in stem cell therapy. Israeli-based Dr. Valentin Fulga was brought in because he has been in the field of cellular therapy for many years, was the previous CEO of ProNeuron (another stem cell company), and had the research contacts to pursue the treatment.
Trials began at Siriraj Hospital. The interim results were so encouraging that the Ethics committee at Chao Phya hospital ruled that cardiologists there could begin treating no-option heart patients on a compassionate basis in the spirit of the Helsinki accord. Later, Dr. Amit Patel, Director of Cardiac Stem Cell Therapies - McGowan Institute, University of Pittsburgh (USA) Medical Center became interested in what was going on in Thailand and quickly realized that the medical standards and practices of the top hospitals in Bangkok are on par with those in the United States. Dr. Patel, who had already conducted successful clinical trials in Uruguay decided to fly to Bangkok where he trained surgeons at Bangkok Heart Hospital to perform the minimally invasive direct injection procedure that he had pioneered. He did this free of cost. Dr. Patel has continued to refer patients to Bangkok Hospital because he believes that they will be helped. He receives no compensation for this.
Incidentally, the treatments given at both hospitals have been cleared by their own ethics boards and by the Medical Ethics Board of Thailand.
So far, only about half of those treated have been foreigners. The rest have been Thai. The treatment is not available to everyone. Only about 1/3 of those patients who pass initial screening are accepted by the hospitals to undergo the procedure. The others are rejected because the cardiologists involved believe that the procedure will not help the patient or in some cases, they determined that the patient was already too ill to undergo any surgical procedure.
At TheraVitae we routinely get requests from desperate people with a wide variety of ailments. We routinely turn many them away because only certain types of heart conditions are treatable and the decision to treat these conditions rests with the cardiologists, not us.
The questions you have raised are good ones. If there is anything more we can do to answer them, please feel free to contact us.
Paul Talbot, Ph.D.
(e-mail contact : email@example.com)
Developments in 2009 (we have deleted intermediate updates between 2005 and 2009)
We follow up on developments in Adult Stem Cell therapy for heart disease through Google Alerts. Every few weeks we get updates, but mostly they only consist of small press releases regarding individual patients who travelled to Thailand, and were reportedly doing well after stem cell therapy.
On the other hand, we keep up-to-date regarding heart disease in general through websites like WebMD and Medscape. We get weekly updates. What we can say is that over the past three, four years, we do not recall seeing any major report regarding this treatment. While experimental treatment are being tried in Thailand and some other countries, it seems fair to say that research in this field is still rather in its initial stages.
It so happens that Forbes published a leading article about Adult Stem Cell therapies in May 2009. The same month both the Bangkok Post and The Nation reported that the Medical Council of Thailand will regulate the use of stem cell technology. Regarding therapy of cardiovascular disease, Forbes reported the following :
"Behind the treatment : Bangkok-headquartered TheraVitae offers VesCell stem-cell treatments through licensing agreements (among others) with four clinics in Bangkok, while research and development activities take place in Israel.
In these procedures, stem cells are extracted from a patient's own blood, cultured in a lab and implanted directly into the blocked coronary artery or, when no artery is available, into the scarred area in the heart. The goal is to rebuild heart muscle and/or improve blood flow. About 350 patients have been treated thus far, says Michael Belkin, a company representative. As for the risks involved, Belkin would only say that there have been 'a small number of serious adverse events' during implantation."
In another development, The Medical Council of Thailand has decided to publicize its new regulations regarding Adult Stem Cell Therapy.
Modified from Bangkok Post dd. 25 May 2009 :
<QUOTE Bangkok Post>
The Medical Council of Thailand has completed a draft regulation on clinical trials using stem cell technology to provide consumers with better protection.
A panel of researchers from medical schools and private hospitals and a representative of the Food and Drug Administration agreed on the draft regulation after years of delaying a decision.
"The purpose of this regulation is to protect consumers from deceptive stem cell therapies," council president Somsak Lohlekha said. "So they don't have to unnecessarily pay huge sums of money for any treatment which is still at the experimental stage."
The draft regulation will be submitted to the public health minister for approval and published in the Royal Gazette. The process will take about three months before the country's first regulation on medical ethics regarding stem cell research for human treatment will be put into effect, he said. The regulation requires all studies on stem cell treatment, except for blood diseases, to be approved by an "ethics and academic panel" as well as the ethics committee of each medical school and hospital where any stem cell research would be undertaken.
Dr Somsak said panel members would be central to decisions on whether stem cell studies on humans at medical schools and hospitals met scientific and ethical standards. He said the panel would be made up of impartial experts on stem cell technology from medical universities.
Doctors conducting stem cell studies would be required to register with the Medical Council for monitoring and consumer protection purposes.
Dr Somsak said private clinics, especially dermatology clinics, providing expensive stem cell treatment were mushrooming, mainly due to a loophole in the drug bill.
He also warned people about businesses that offer storage of stem cells at birth, which can cost as much as 200,000 baht.
Such services are reportedly popular among wealthy people who believe technological advancements will allow the cells to be used for treating future diseases.
He said scientific innovations could retrieve stem cells from blood for treatment at much cheaper cost. A warning on these misleading advertisements would be published on the Medical Council website, he said.
<END QUOTE Bangkok Post>
The report in the Nation newspaper of the same day, had a slightly different undertone. It put more stress on the fact that some treatments will be banned (with violations punishable by medical licence withdrawals), and that only research and studies would be allowed. That would rather preclude the presently performed therapies on heart disease patients.
<QUOTE The Nation>
Starting in September when a decree to regulate human stemcell study comes into effect, any hospital or medical school found to be carrying out tests in violation of the rules or without permission will ultimately face withdrawal of medical licence, the Medical Council said yesterday.
Council chairman Dr Somsak Lohlekha said the decree will not allow treatments based on the use of human stem cells. "Only studies or researches in relation to human stem cells will be allowed, with mandatory approval from a national regulatory body," he added.
The decree will regulate study and research into the use of human stem cells in treating all diseases, especially those involving dermatology, treatment of veins, organ trans?plants, and all heart related diseases, expect for bone marrow transplant and blood disorders, which have been practised.
The decree will be regulated mainly by a national body, which would be set up later and comprise ex-officio members from various professions, including representatives from the Supreme Court and the Law Society of Thailand.
The Public Health Ministry and the Food and Drugs Administration will enforce regulations under the decree.
The Medical Council has just completed its final version of the decree and will scrutinise it at its major meeting next month. The decree is expected to come into effect after a threemonth process.
During the process, Somsak said many medical schools had opposed the decree, saying it would affect stemcell studies in Thailand, but all parties had finally reached an agreement in finally promulgating the decree.
The Medical Council will soon make an announcement encouraging members of the public or companies to stop storing their own stem cells from umbilical cords for future use, because the storage of such cells was costly and becoming outdated, as the general stem cells could now be extracted from other body parts.
Somsak said the storage of stemcell umbilical cords in the US had been discontinued many years ago.
<END QUOTE The Nation>
Not everything is clear yet. On the one hand, the Bangkok Post speaks about a draft that still has to be ratified. The Nation states that regulations will come into effect as from September 2009, though they still need to be 'scrutinised'.
This being Thailand, we would not be surprised if in the following months, opinions change, and the present 'draft' is significantly modified.
We are pleased to see the comment about umbilical cord blood stem cells. On the one hand, it clearly seemed that we would get two groups of babies. One group with parents that could afford to pay the large sums of money to store the stem cells, the other without such parents. There is something rather unfair in this.
On the other hand, we felt that the 'rich' parents were taken advantage off. Something new was created that parents needed to do to take care of their kids. Fear of (rare) diseases, and avoidance of guilt (in case something happens later on, and we did not take provisions) seemed the driving force, with the greed of the storage providers behind it all. It is good to know that this storage of umbilical cord blood and stem cells is considered outdated. Just puzzled what will happen now (or sometime soon) with all the blood already collected (and paid for).
Further info (this website) about storing blood from umbilical cord.