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Published on September 7, 2007

They are labelled with the patient's name and are accompanied by documents that state how many stem cells were available at the time they were packaged in Israel.

There is no check done in Bangkok to determine if the cells are really the patient's cells. There is no procedure to ensure there was no mix-up with someone else's cells.

One stem-cell company admits that their stem-cell product has a very short "shelf life" and the practice has been to have the patient prepped and on the operating table as the cells are transported from the airport to the hospital. This is because the cells, already out of the patient's body for a week, are continuously dying off.

Timing is critical, and there is no re-check of the stem cells done in Bangkok to ensure the stem cells in the syringes are alive, or what the count of live cells is immediately prior to implantation.

The Thai doctors using the stem-cell product are good, competent doctors of the highest calibre.

They provided me with the best of care when I had my stem-cell surgery. That, however, does not change the fact there is no check performed on the cells in Thailand after they are delivered from the lab in Israel.

To check the cells, they would have to be removed from their pre-filled syringes in a certified GMP laboratory and processed through a flow cytometer for an accurate count of live cells.

One stem-cell company's website says their cells are used in several hospitals in Thailand. Do each of those hospitals have a certified GMP lab?

If so (and that is highly doubtful due to the difficulty in acquiring GMP certification), does each of those labs open the pre-filled syringes and individually test them? Is any genetic testing done on the cells to ensure another patient's cells were not mistakenly labelled as the patient about to receive them? No such testing is done in Thailand.

This is why the Thai FDA must develop policies and regulations regarding the use of stem cells in Thailand, and it is imperative that the Thai Medical Council prohibit the use of unchecked stem cells until such time as proper regulatory measures are enacted and legitimate laboratory testing is made available to test the arriving stem-cell product before it is used on patients.

Even more importantly, Thai authorities should ponder the effect that allowing the use of stem cells prepared in an uncertified lab might have on the emerging medical tourism industry in Thailand.

The Thai authorities unfortunately lack experience in the emerging stem-cell field, and that, in addition to the risks to patients' health, is why the Thai government should immediately stop the use of stem cells while they investigate this matter and develop regulations regarding the proper use of stem cells in Thailand.

Harry J DePietro

OHIO

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Stem-cell research has yielded promising results

Re: "More research needed: doctor", News, August 31.

I read with interest the article on THAI StemLife's research on the use of adult peripheral blood stem cells in the treatment of diabetic ulcers, sponsored by the National Innovation Agency and carried out at leading university and private hospitals after local ethical committee approvals were granted. The stem cells used are non modified (non-cultured, non-expanded) autologous (the person's own) stem cells collected from peripheral blood (PBSC) using a standard FDA approved leukaphaeresis machine, thereafter cryogenically frozen and eventually thawed following FACT/AABB/FDA regulations, identical to the collection and storage procedures applicable on stem cells to be used in bone marrow transplants.

Bone marrow transplantation (BMT) has increasingly been used to treat cancer and diseases of the bone marrow since 1957 and ED Thomas received the Nobel Prize for medicine in 1990 for his pioneering work. Today, an estimated 45,000 to 50,000 hematopoietic stem-cell transplants are performed annually worldwide to treat patients with life-threatening malignant and non-malignant diseases.

In 60 per cent of the cases, autologous cells (patient's own) and related allogeneic cells (from within the patient's family in 80 per cent of the cases), rather than unrelated allogeneic cells (unrelated donor), were used.

Significant research has been done in the field of diabetic ulcer treatment by adult stem cells, with results published in international journals. Hundreds of patients have benefited - not only two as mentioned in the article - in Japan, China, Germany and the US (in a running study at Indiana University), with results that we seem to reproduce successfully using easier and less invasive methods.

Furthermore, the reporter seems to confuse the biological effects of stem cells. It is not true that we did not want "to study the generation of stem cells after injection in human cells", which as a sentence makes no sense.

What, presumably, the reporter means - and similarly to us, wants to know - is "how are the injected autologous stem cells working to make new blood vessels, grow new tissue and heal the wound?"

This answer has partially been given via the research mentioned above and we seem to know now that the injected stem cells fuse with local cells, differentiate to local cell types, and/or secrete tissue factors that promote vessel growth. This is clinically proven by contrast X-ray pictures before and two months after treatment.

The presence of injected stem cells in the treated tissues and the increase in involved vessel growth factors have been proven by biopsies done on amputated limbs treated by stem cells. In our samples only one amputation of a gangrenous toe has happened and therefore we have not been able to look at our own biopsies.

It would be unethical to make a biopsy on a healed limb to look at something we probably know the answer to.

The results are satisfying, promising, and our study is on a par with similar studies carried out in Europe and in the US.

The stem cells used are the patient's own without any modifications (no ex vivo culture, no differentiations, no expansions, no feeder cells, no bovine culture media) that would necessitate regulations different than the ones applicable in bone marrow transplantation/s.

The infusion methods and X-ray visualisation studies do not differ from standard care in diabetic peripheral arterial disease and ulcer treatment. But as in all situations in medicine, "primum non nocere" - "do not harm", as Hippocrates said. Extended ethical and regulated research is imperative. All references mentioned in the text are available upon request.

Dr Kostas I Papadopoulos

Chief Operations Officer, THAI StemLife

BANGKOK

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Samak an outdated proxy at best

Re: "Samak vows amnesty for banned 111", News, September 6.

A few weeks into his new post as leader of the People Power Party and Samak Sundaravej already envisages himself as our next prime minister. He even plans to pardon all 111 former TRT executives banned from politics for electoral fraud. He also aims for these people to "do the work passed on from me" once he becomes our next head of government.

Samak may have outgrown his importance. He may even be daydreaming. Prior to his appointment in the PPP, he was already considered a failure and over the hill, partly because of his lack of leadership, but mainly because of his loose mouth.

Samak should be reminded that he is just a cog in the wheel of the TRT juggernaut that belongs to Thaksin exclusively. Even his influence and charisma is lent from the former leader. His importance should rest at that.

Chavalit Van

CHIANG MAI

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A regular cycle of preventable disaster

At regular intervals there is the announcement of yet another massively overloaded boat that overturns, killing at least one person. This prompts the usual bluster in response from the authorities, after which nothing is done, and we wait for the next one to occur.

The typical cycle is easy to break down: owner/operator orders captain to overload boat; boat turns over; captain blamed; owner/operator gets new captain to overload boat; and so on. The recent incident was not the first and it will not be the last.

Christian Lloyd

BANGKOK

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