I agree with part of this article and that is Buyer Beware, however, U.S. doctors have got to get over some of their skepticism and get with the program. The details are foggy here, so I won't speculate if this could have happened, but I did note that they pointed out the case of the Israeli boy who developed a tumor. This is one case and the clinic was not the type of clinic that I would ever step foot in, but to point this out as an example as to why we should all sit around and die waiting for the U.S. to finally get its rear in gear and start researching and eventually treating people is ridiculous. We are given no credit for having even a partial brain and they try once again to use scare tactics to make us wait while they figure out what they are doing and how they are going to make up their lost revenue without transplants, surgeries and tons of drugs. There are some good American doctors who are treating out of frustration, for the most part, in other countries. This is not to say that we should throw all caution to the wind, but my point is that many of us are tired of the years of rodent studies and would be more than agreeable to participate in clinical trials rather than invite the grim reaper in just yet. Many simply do not have the luxury of waiting for years and that is why other countries and their much more lenient policies are inviting to stem cell companies, doctors and patients alike.
Here is an article about the child that developed a tumor:
Nature Reports Stem Cells
Published online: 26 February 2009 | doi:10.1038/stemcells.2009.34
Stem cell clinical trials must be closely monitored
Clive Svendsen1
Results of unregulated stem cell transplant were predictable and avoidable
The study by Amariglio et al. describes a stem cell transplant attempt in a child with ataxia telangiectasia, a rare genetic disease that leads to poor coordination and dilation of blood vessels1. These patients also have weakened immune systems and are more prone to cancer.
There has been a growing demand that stem cell cures be developed for many diseases. This has led to US and European families feeling that not enough is being done, and an alarming number of patients are being drawn to overseas clinics for costly but poorly defined stem cell treatments.
In this case, the parents of the child with ataxia telangiectasia took him to Russia for a stem cell treatment ? presumably hoping that the foetal stem cells would somehow reverse the disease process. However, there is no published evidence of this occurring in animal models, and the paper presents no clear rationale of how it might have worked had it been successful.
The Russian surgeons collected eight-week-old foetal brain tissue (presumably from elective abortions). The tissue, from an undefined brain region, was then removed and expanded in culture for 12?16 days. Between 50 and 100 million cells were then injected into the white matter of the patient's cerebellum by direct injection and into the spinal cord using a lumbar puncture technique. Compared with other trials in which cells derived from foetal tissues have been transplanted into animals or patients, this is an enormous number of cells (orders of magnitude greater than anything previously reported). None of the surgical methods were described in any detail. Apparently the child returned to Russia for three treatments over a period of a few years, tripling the total number of cells received up to 300 million.
The result was entirely predictable based on the current knowledge of foetal tissue stem cell growth and differentiation following transplantation into animal models. A tumour is most simply defined as a lump of growing tissue that is either benign or cancerous. The cells began to form lumps of growing tissue, or tumours, that had both neural and glial cells. This is exactly what these cells are designed to do by nature. Taken at a very early stage of development perhaps from a region that is destined to make billions of cells (the human cortex), the foetal cells tried to make a mini-brain in the spinal cord. Although it was difficult to establish from the limited data in this report, there were no overt signs of excessive cell growth, perivascular cuffing or chromosomal abnormalities within the growing cells, all of which would suggest a cancerous tumour. There was simply a lump of apparently benign cells that contained healthy neurons and astrocytes near the area of the injection. This is in fact very encouraging for future clinical trials in which the correct administration and dose of cells could be established.
The conclusion from this report is that injecting millions of human foetal cells into the brain or spinal cord will result in a tissue mass that continues to develop over time ? just like a developing human brain would in the foetus. It, along with data from preclinical animal studies, tells us that we should carefully control the number of cells that we transplant, as any growing mass in a restricted region of the brain or spinal cord is potentially dangerous. The paper also shows that repeatedly injecting hundreds of millions of stem cells is not going to make a patient better, and it raises a number of very worrying concerns over regulations and rationale for stem cell therapies abroad that are not FDA approved.
This is a crucial paper because it highlights the importance of careful FDA monitoring for any stem cell clinical trials in the United States. This will protect patients and their families from poorly designed, expensive, naive and dangerous clinical trials such as the one described in this report.
References
1. Amariglio, N. et al. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med. 6, e1000029 (2009); doi:10.1371/journal.pmed.1000029.
Author affiliations
1. Clive Svendsen is professor of anatomy and neurology and Co-Director of the Stem Cell and Regenerative Medicine Center at the University of Wisconsin at Madison.
