Stem-Cell Patient Dies In Bangkok

[webfact]

Stem-cell patient dies in Bangkok

By Pongphon Sarnsamak

The Nation

Death of woman, 46, followed treatment at private clinic

BANGKOK: -- An endstage kidney patient died after she received stem cell injections at a private clinic in Bangkok and developed complications, according to Thai and Canadian research published in the "Journal of the American Society of Nephrology".

"The case was reported as Thailand's first fatality caused by stem cell therapy," Duangpen Thirabanjasak, a researcher in the Department of Pathology at Chulalongkorn University's Faculty of Medicine, said yesterday.

The 46yearold woman had suffered from systemic lupus erythematosus for over 20 years with diffuse proliferative lupus nephritis.

In 2006, she went to the private clinic for stem cell therapy, where she was given multiple direct injections of autologous stem cells into the regions of both kidneys during a single visit.

Although no details of this treatment conducted by the private clinic were available, Duangpen said the woman's condition did not improve and six months later, the patient developed pain and hematuria in her left flank.

Duangpen said she examined the patient's kidney tissues and found abnormal cells called angiomyeloproliferative lesions at the injection site.

"The abnormality looked like a cluster of blood vessels and bone marrow cells," she said.

The development of an abnormality in the patient's kidney cells might be a complication from stem cell therapy, she said.

However, the results from several animal experiments studying various organs including kidneys have shown that therapy using autologous stem cells and other stem cells is safe, she said.

Now the public, especially helpless and hopeless patients, should be cautioned about stem cell therapy, she said.

In Thailand, physicians working in state and private hospitals have been using stem cell therapy to treat chronic diseases such as heart failure, Parkinson's and diabetes. But there is no proof yet that stem cell therapy can cure these diseases and there is a potential for harm to patients, she said.

According to the Medical Council, physicians would only be allowed to provide stem cell therapy that was based on scientific research and had been approved by the council as standard treatment.

However, the council has approved only one standard treatment - the transplanting of bone marrow to treat leukaemia. This has been used for more than 40 years.

Physicians providing stem cell therapy also will need to be certified by the Medical Council. Violators will have their medical licences revoked.

The Food and Drug Administration has also banned the advertising and sale of cosmetics containing stem cell material.

-- The Nation 2010-08-02

[siampolee]

However, the results from several animal experiments studying various organs including kidneys have shown that therapy using autologous stem cells and other stem cells is safe, she said.

Thalidomide was considered safe too, look at the dreadful birth defects that resulted from the use of the drug, however Thalidomide is now prescribed for other purposes and works well.

Stem cell work is still in its infancy more time is needed, I can understand someone taking the risk the chance to live rather than die is indeed worthy of a gamble.

Now the public, especially helpless and hopeless patients, should be cautioned about stem cell therapy, she said.

In Thailand, physicians working in state and private hospitals have been using stem cell therapy to treat chronic diseases such as heart failure, Parkinson's and diabetes. But there is no proof yet that stem cell therapy can cure these diseases and there is a potential for harm to patients, she said.

According to the Medical Council, physicians would only be allowed to provide stem cell therapy that was based on scientific research and had been approved by the council as standard treatment.

However, the council has approved only one standard treatment - the transplanting of bone marrow to treat leukaemia. This has been used for more than 40 years.

Therein lies the answer.

Edited August 1, 2010 by siampolee

[meelousee]

In a think tank headed by top educators in medicine, internal medicine, and genetic research have called this "Rat Science" not because it does not work or is bad. Only in the last 5 years have they tried it on pigs, next will be upper primates (apes not monkeys}

It will take time do not shun it on one tragic death. Lupis is an awful disease and will destroy your kidneys transplants are not an option. An endstage kidney patient has only one option, 'stem cell treatment' this lady would have been dead in 6 to 9 months anyway.

Peace to her family

[ding]

The US media will take this and run. The more radical Christians in the US seem to be the tail wagging the dog in these matters.

[geriatrickid]

Nothing like reporting events after the fact. Is the sudden interest because of a complaint to Medical Council? This article was published 4 months ago based upon activity that is almost a year old. Get your umbrellas ready boys and girls, the sh*t is going to hit the fan. My understanding is that there is an allegation of a breach of ethics.

There is a another thread running in respect to the attempt to make Phuket a medical tourism thread. In that thread I have pointed out and emphasized the approach to bioethics in Asia. Here we see a clear example of a questionable activity. The Medical Council of Thailand must act and hold a thorough investigation. If the physicians involved have violated treatment ethics as I believe they have, then they must be sanctioned. However, I will be very surprised if that happens.

Before anyone jumps over the two authors of the study, please note they only removed the kidney from the deceased patient and reported their findings. They did not kill the patient. These are two reputable pathologists and have distinguished careers, so please, no bashing.

Ok, so here's the abstract;

Angiomyeloproliferative Lesions Following Autologous Stem Cell Therapy

Duangpen Thirabanjasak^*, Kavirach Tantiwongseand Paul Scott Thorner^*Departments of *Pathology and Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Pathology, Hospital for Sick Children, Toronto, Canada; and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada Received for publication November 16, 2009. Accepted for publication March 28, 2010.

Some reports suggest that autologous hematopoietic stem celltransplantation holds potential for treatment of renal diseasessuch as lupus nephritis, but the safety of delivering variousstem cell types (hematopoietic, mesenchymal, and endothelialprecursors) is not well established. Here, we report a caseof lupus nephritis treated by direct renal injection of autologousstem cells recovered from peripheral blood. The patient developedmasses at the sites of injection and hematuria. We suspectedtransitional cell carcinoma but nephrectomy revealed that themasses were angiomyeloproliferative lesions. We believe thatthis previously undescribed pathologic entity is stem cell–derivedor –induced. The biologic potential, including the neoplasticpotential, of this lesion is unknown. This case illustratesthat the development of angiomyeloproliferative lesions is apossible complication of stem cell therapy.

In plain English'

They found that the patient had not benefited at all from the treatment. In all likelihood, the treatment killed the patient.

What the nation did not report;

The authors conclude that their findings should serve as a warning to clinical investigators that the development of blood vessel and bone marrow masses may be a possible complication of stem cell therapy. And they said more work was needed to identify why the masses formed, and how this could be avoided.

Writing in the same journal, Andras Nagy, of Toronto's Mount Sinai Hospital, and Susan Quaggin, of the University of Toronto, said caution was needed over stem cell therapies - especially if they were being offered by unregulated private clinics. Premature enthusiasm and protocols that are not fully vetted are dangerous and result in negative publicity for the field of stem cell research, and more importantly, may result in disastrous outcomes with no benefit to the patient. Although there is promise, a large gap still exists between scientific knowledge and clinical translation for safe and effective stem cell-based therapies.

Does anyone think that the private hospital undertook an ethical review prior to undertaking the treatment? Where did they harvest the stem cells from?

Who knows? Nothing is public.

And why does the Thai Medical Council need a kick in its pants from researchers in Canada to respond?

[jdfmail]

In a think tank headed by top educators in medicine, internal medicine, and genetic research have called this "Rat Science" not because it does not work or is bad. Only in the last 5 years have they tried it on pigs, next will be upper primates (apes not monkeys}

It will take time do not shun it on one tragic death. Lupis is an awful disease and will destroy your kidneys transplants are not an option. An endstage kidney patient has only one option, 'stem cell treatment' this lady would have been dead in 6 to 9 months anyway.

Peace to her family

She lived with lupus for 20 years, so how do you come up with the conclusion that she would have died in 6 to 9 months? My aunt lived into her late 50s with this disease when dialysis was more difficult than it is today.

[jayjay0]

The article states

"

In Thailand, physicians working in state and private hospitals have been using stem cell therapy to treat chronic diseases such as heart failure, Parkinson's and diabetes. But there is no proof yet that stem cell therapy can cure these diseases and there is a potential for harm to patients, she said."

Just to play the devils advocate she could just as easily said there is no proof that stem cell therapy can not cure these diseases, and there is a potential for a full recovery for the patients.

There is no proof of either statement. Stem cell research is still a young and unproven science. I would tend to believe that by the time Science can say it is a good tool in there medical kit or it will not work at all. There will be more than one person dead. And they will not all be at the hands of unregulated doctors. I firmly believe that she was not the first to die after the treatment and she will not be the last. Let's face reality there are patients dying on surgery tables all over the world in accredited regulated hospitals undergoing acceptable procedures. The whole field is still in it's infancy. Give it a chance. Do not judge it on one caase in a private hospital in Thailand.

[SamritT]

So sorry to hear that. maybe human should not play GOD. BTW, do you think that she looked like me.

Edited August 3, 2010 by SamritT

[jayjay0]

So sorry to hear that. maybe human should not play GOD. BTW, do you think that she looked like me.

Definitely your much much older sister.

[geriatrickid]

jayjay0,

You are missing the point: New therapies and treatments should be undertaken under specific circumstances with an emphasis upon oversight and review. When people start applying these treatments and therapies outside the structure that allows for checks and balances, they sabotage and disrupt legitimate research and imperil the lives of those that could benefit from the innovations. Stem cell treatments are still being researched and must be left to those facilities and personnel best equipped and trained to test the therapy.

Plenty of for profit facilities throughout the world undertake innovative treatments, but they act within the context of bonafide R&D activity. The teaching hospitals affiliated with Mahidol & Chula are able to do such research, but they didn't. Why do you think that is? My gut feeling tells me is that the proposed treatment would not have passed review. Allowing unapproved, unregulated treatments willy nilly damages the integrity and reliability of the health care system and brings shame to countries . remember the rip off cancer treatments that mexico was famous for back in the '70's? It damaged Mexico/s medical tourism niche when sanctions were imposed. If Thailand doesn't get out in front of this, it could face serious sanctions that impact the money transferred from the WHO and various governments (USA, Canada, Germany, Japan) along with funds from the Gates & Clinton foundations for research and health care projects. That's the part of the story, people must appreciate. There are conditions attached to funding and some of those strings require a rigid enforcement of a code of ethics. Honest, ethical scientists may suffer because of this.

[jayjay0]

jayjay0,

You are missing the point: New therapies and treatments should be undertaken under specific circumstances with an emphasis upon oversight and review. When people start applying these treatments and therapies outside the structure that allows for checks and balances, they sabotage and disrupt legitimate research and imperil the lives of those that could benefit from the innovations. Stem cell treatments are still being researched and must be left to those facilities and personnel best equipped and trained to test the therapy.

Plenty of for profit facilities throughout the world undertake innovative treatments, but they act within the context of bonafide R&D activity. The teaching hospitals affiliated with Mahidol & Chula are able to do such research, but they didn't. Why do you think that is? My gut feeling tells me is that the proposed treatment would not have passed review. Allowing unapproved, unregulated treatments willy nilly damages the integrity and reliability of the health care system and brings shame to countries . remember the rip off cancer treatments that mexico was famous for back in the '70's? It damaged Mexico/s medical tourism niche when sanctions were imposed. If Thailand doesn't get out in front of this, it could face serious sanctions that impact the money transferred from the WHO and various governments (USA, Canada, Germany, Japan) along with funds from the Gates & Clinton foundations for research and health care projects. That's the part of the story, people must appreciate. There are conditions attached to funding and some of those strings require a rigid enforcement of a code of ethics. Honest, ethical scientists may suffer because of this.

Well for the most part I agree with you. I however do not think that one instance is going to bring doom and gloom to Thailand. Yes Thailand does not have any standards for hospitals to meet. It would be nice if they did but they would have to be fairly low other wise some of the smaller ones in outlying areas would have to close.

At any rate you said.

"Allowing unapproved, unregulated treatments willy nilly damages the integrity and reliability of the health care system and brings shame to countries"

While this is true I really don't believe that will happen here in Thailand. You will notice it was a Thai. Also let us remember we really don't know what standards were adhered to at that hospital. Let us remember there was a time when that was all the research that was going on. We have defiantly out grown that now. Been awhile .Was wondering if he States were still trying to please the religious people or have they got a meaningful plan in effect.

Is that hospital doing research or using existing research. From all I know of this process it can revolutionize medical care and as you say should be under supervision. It would be nice if it could be coordinated but that is asking for to much.

now I am rambling.

[JohnLeech]

In plain English'

They found that the patient had not benefited at all from the treatment. In all likelihood, the treatment killed the patient.

I am not supporting or opposing stem cell therapy, but NO, that is NOT what they said. They never inferred, insinuated or implied that "in all likelihood, the treatment killed the patient". Maybe they were careful to avoid doing so, but that is purely your interpretation of what you imagine an autopsy report that you have never seen may have said.

As you rightly say, however, "Who knows? Nothing is public".

[tw25rw]

So sorry to hear that. maybe human should not play GOD. BTW, do you think that she looked like me.

Doctors do more to help people than any "god" ever has. This is a new treatment that is still basically experimental and will eventually become commonplace and reliable.

[edgarfriendly]

anyone here actually involved in any of this with anything to add?

some of the repetitious posters' rhetoric and/or 'trolling' is wearing a 'bit' thin.

dr?

ef

[Deeral]

Can anyone shed light as to the name of the clinic concerned and where it is located.?

Edited February 19, 2011 by Deeral

[ParadiseLost]

If this clinic provided the treatment in the name of research i.e. the patient was paid to undergo the treatment then I can support the doctor but this is highly unlikely. What is more likely is the poor desperate woman was enticed by promises of a possible miracle cure and she paid a huge price - both financially and with her life.

The family of the victim should surely be able to sue the doctor for malpractice.

The most basic human instinct is survival and there will always be desperate, terminally ill people wishing to alleviate their suffering - it should be a capital offence for medical practitioners to offer 'miracle' cures to these poor souls for monetary gain.

A similar situation exists with assisted suicide and abortion - there are always shady quacks willing to profit from others' misery.

Perhaps R&D clinics should be allowed to offer earlier human testing programs to volunteers - but only if no money changes hands...

[Deeral]

jayjay0,

You are missing the point: New therapies and treatments should be undertaken under specific circumstances with an emphasis upon oversight and review. When people start applying these treatments and therapies outside the structure that allows for checks and balances, they sabotage and disrupt legitimate research and imperil the lives of those that could benefit from the innovations. Stem cell treatments are still being researched and must be left to those facilities and personnel best equipped and trained to test the therapy.

Plenty of for profit facilities throughout the world undertake innovative treatments, but they act within the context of bonafide R&D activity. The teaching hospitals affiliated with Mahidol & Chula are able to do such research, but they didn't. Why do you think that is? My gut feeling tells me is that the proposed treatment would not have passed review. Allowing unapproved, unregulated treatments willy nilly damages the integrity and reliability of the health care system and brings shame to countries . remember the rip off cancer treatments that mexico was famous for back in the '70's? It damaged Mexico/s medical tourism niche when sanctions were imposed. If Thailand doesn't get out in front of this, it could face serious sanctions that impact the money transferred from the WHO and various governments (USA, Canada, Germany, Japan) along with funds from the Gates & Clinton foundations for research and health care projects. That's the part of the story, people must appreciate. There are conditions attached to funding and some of those strings require a rigid enforcement of a code of ethics. Honest, ethical scientists may suffer because of this.

Well for the most part I agree with you. I however do not think that one instance is going to bring doom and gloom to Thailand. Yes Thailand does not have any standards for hospitals to meet. It would be nice if they did but they would have to be fairly low other wise some of the smaller ones in outlying areas would have to close.

At any rate you said.

"Allowing unapproved, unregulated treatments willy nilly damages the integrity and reliability of the health care system and brings shame to countries"

While this is true I really don't believe that will happen here in Thailand. You will notice it was a Thai. Also let us remember we really don't know what standards were adhered to at that hospital. Let us remember there was a time when that was all the research that was going on. We have defiantly out grown that now. Been awhile .Was wondering if he States were still trying to please the religious people or have they got a meaningful plan in effect.

Is that hospital doing research or using existing research. From all I know of this process it can revolutionize medical care and as you say should be under supervision. It would be nice if it could be coordinated but that is asking for to much.

now I am rambling.

" I however do not think that one instance is going to bring doom and gloom to Thailand."

unfortunately it is not a single incident. The health system of Thailand is poorly regulated and monitored and all sorts of un-trialed, alternative, complimentary and pseudoscience practices are happily carried out here - often within the walls or with the acquiescence of the main hospitals, both government and private.

what I find of concern in particular here is that wherever I look for the identity of the "clinic" involved has been brushed over. WHY????

One obvious assumption would be that this is because they operated under the wing of one of the major private healthcare companies such as Bumrungrad?

[Spee]

The US media will take this and run. The more radical Christians in the US seem to be the tail wagging the dog in these matters.

Your hit and run post is way, Way, WAY over the top.

The fringe religious sects in the US who shun transfusions, transplants and similar treatments are less than 1% of the population. Other Christian groups who fight against stem cell use, do so in the context of fetal stem cells on aborted infants. Again, when taken in context, this equates to a small percent of the situation.

This poor woman's plight was very unfortunate, but as people know and freely admit, there is a solid base of evidence that stem cell treatments do work. But it is an imcomplete science. Even bone marrow transplants do not solve the problem every time.

I speak from experience because I have been through chemotherapy and have leukemia in remission. When people talk about transplants, bypass, chemotherapy, radiation therapy, stem cells, etc., it's done in terms of risk and probability.

When a doctor tells you to take a pain reliever for a headache, for the typical person there is essentially zero risk and near 100% probability that it will resolve the problem.

When a doctor discusses chemo, transplant, bypass or other more radical treatments, there is increased risk (i.e., will the chemo kill the patient, or is the patient likely to die without treatment) and the results are almost always based in probability and statistics. In order to be able to rely on statistics, there has to be a build up of cases and evidence. The more numbers there are, the better the doctors and scientists understand the risks and likelihood of success.

While we're at it, let's talk about why these things are being done in places like Thailand, rather that other countries. There is the bureacracy of the regulatory agencies, such as the FDA in the US. The FDA has almost sure prevented some deaths by keeping bad chemicals off the market. But they have just as surely killed people by letting bad chemicals get to market, and have just as surely killed people by preventing good chemicals from getting to market. On that basis, what is the real value of these organizations?

[Deeral]

The US media will take this and run. The more radical Christians in the US seem to be the tail wagging the dog in these matters.

Your hit and run post is way, Way, WAY over the top.

The fringe religious sects in the US who shun transfusions, transplants and similar treatments are less than 1% of the population. Other Christian groups who fight against stem cell use, do so in the context of fetal stem cells on aborted infants. Again, when taken in context, this equates to a small percent of the situation.

This poor woman's plight was very unfortunate, but as people know and freely admit, there is a solid base of evidence that stem cell treatments do work. But it is an imcomplete science. Even bone marrow transplants do not solve the problem every time.

I speak from experience because I have been through chemotherapy and have leukemia in remission. When people talk about transplants, bypass, chemotherapy, radiation therapy, stem cells, etc., it's done in terms of risk and probability.

When a doctor tells you to take a pain reliever for a headache, for the typical person there is essentially zero risk and near 100% probability that it will resolve the problem.

When a doctor discusses chemo, transplant, bypass or other more radical treatments, there is increased risk (i.e., will the chemo kill the patient, or is the patient likely to die without treatment) and the results are almost always based in probability and statistics. In order to be able to rely on statistics, there has to be a build up of cases and evidence. The more numbers there are, the better the doctors and scientists understand the risks and likelihood of success.

While we're at it, let's talk about why these things are being done in places like Thailand, rather that other countries. There is the bureacracy of the regulatory agencies, such as the FDA in the US. The FDA has almost sure prevented some deaths by keeping bad chemicals off the market. But they have just as surely killed people by letting bad chemicals get to market, and have just as surely killed people by preventing good chemicals from getting to market. On that basis, what is the real value of these organizations?

THe value is that they exist and exist in a country where laws and regulations are enforced - sometimes too late and sometimes inappropriately. THose who feel they are damaged by a person or institution claiming to help them can seek a remedy under the law.... in Thailand however they have virtually NO REDRESS whatsoever and the health system knows this and is anxious to protect the situation which is primarily to the detriment of the patient and beneficial to those looking to make an easy buck.

Furthermore the procedures used on this woman were not the ones accepted and carried by other doctors; the stem cells were injected directly into the kidneys.

Many "fringe" medical practices that are weeded out by various bodies in US and Europe find a comfy home and a lucrative living here in Thailand where there is nothing to check the veracity of their claims.

......and they all say the same thing - the medical profession is too restrictive and blinkered to new concepts where they come from - this is simply not the truth - if you have a potential cure or treatment it is NOT verified as some above seem to think by trial and error on "guinea pigs", that's the stuff of science fiction and comic books. Medical treatments are established by clinical trials that are then peer reviewed and the well documented environment and results are then repeated......much of this is long before trials on humans occur.

These fringe, quack and charlatan elements simply cannot come up with plausible, verifiable scientific evidence. So they are refused permission to operate their business....then they look for countries where they can avoid such "inconvenient" regulations.

THeir advertisements should be enough to put people off, making wild claims, spreading fears and publishing testimonials endorsements by "members of the public" and claiming this to be satisfactory evidence that their particular treatment is effective (and even safe?). - these people are COMPLETELY UNQUALIFIED to venture any sort of opinion, yet they are so often the ONLY source of confirmation - no scientific trials at all!

Usually they don't focus on the condition itself rather than praising the environment they are treated in and the "accreditations to which they are "linked" but not actually covered. to do this many operate within the walls or under the umbrella of one of the big private hospitals who seem quite happy to ignore any medical inconsistencies in favour of the extra income they bring.

This I'm sure is a clue to the reason the "clinic" involved in the death of this woman has been withheld. THere are powerful/influential people and institutions that would look very red-faced and lose a lot of income if it were to come out.

Basically - miracle cures can't be bought - those selling them are preying on those who so often are in a hopeless situation and they just rip them off before they die - (you can't complain when you're dead)

[WarpSpeed]

In a think tank headed by top educators in medicine, internal medicine, and genetic research have called this "Rat Science" not because it does not work or is bad. Only in the last 5 years have they tried it on pigs, next will be upper primates (apes not monkeys}

It will take time do not shun it on one tragic death. Lupis is an awful disease and will destroy your kidneys transplants are not an option. An endstage kidney patient has only one option, 'stem cell treatment' this lady would have been dead in 6 to 9 months anyway.

Peace to her family

She lived with lupus for 20 years, so how do you come up with the conclusion that she would have died in 6 to 9 months? My aunt lived into her late 50s with this disease when dialysis was more difficult than it is today.

Maybe because the OP states she was in end stage?? Usually that indicates past available conventional treatment techniques effectiveness and a count down begins..

[Deeral]

I think amateur diagnostics are not helpful here - you don't know the patient's case and can only guess at the prognosis.What appears to be certain is that a treatment that would not have been permitted in many countries killed here - I understand that the stem cells formed lumps in her kidneys.THe real issue is that this kind of unregulated practice can still happen in /Thailand and patients are still at risk.There has been no disciplinary action and the NAME OF THE CLINIC remains a mystery.Over a quarter of foreign patients treated in Thailand come here for the specific purpose of treatment and it is often the lure of treatment they can't get elsewhere that attracts them - these people rather than getting a "cure" could well be putting themselves unwittingly in danger