A revolution in Chinese stem cell technology

Press TV Print Page 1 of 6 A revolution in Chinese stem cell technology Mon, 12 Nov 2007 00:30:46 By Patricia Khashayar MD, Press TV, Tehran Dr Sean Hu, the chairman and founder of Beike Biotechnology, got a PhD in molecular biology from Gothenburg University in Sweden; He has received his post doctoral training at the University of British Colombia in Vancouver. Since 1999, he has decided to get involved in the business side of the research industry as well. As a result, he has set up a company to distribute dental products in China and a hospital management company, which were a good preparation for Beike. He believes his research basis had given him a good understanding of what the scientists were doing and good hospital management. 'This is especially true when treating foreign patients because they require a different standard of care you cannot get in most hospitals.' Q. Could you tell us about your center and the researches conducted there. Also tell us about your role in these researches. A. The early research conducted in our center was focused on a few types of stem cells used for clinical treatment. Our researchers conducted many studies and at last realized that umbilical cord blood stem cells work as well as some of the more controversial types of stem cells for treating several neurological diseases. Thus, we decided to focus on those cells. We also found that bone marrow and peripheral blood stem cells are a better choice in vascular diseases. Later we discovered amniotic membrane stem cells are more effective in various neurological diseases compared with the umbilical cord blood. Now we are working on a series of clinical trials in China in order to obtain SFDA treatment approval and to make this type of treatments feasible for different centers. The technology that we are using is still very basic and in time will be available at every hospital, so we need to keep our R&D going in order to keep our product pipeline full. As such, we are focusing on basic research involving reprogramming and other advanced technologies with the $4 million grant we just received from the government in partnership with China's leading university of science, Qinghua University. I determine the general direction of the research but I let the scientists do their job. I just support them however I can. My job in general is to help my colleagues do their jobs to the best of their ability. I think this is what any good CEO should do. Q. Stem cells are one of the most important fields commonly studied by researchers all over the world. What inspired your interest in such an area and how did you eventually choose this field for research? A. I was always interested in stem cells because of my work in molecular biology. When I read the news indicating the first ALS patient treated in China in 2001, I went straight to that university and introduced myself to the lead scientist, Yang Bo. Over the next two years I went and met every scientists involved in stem cell research. I found out this science the most progressive science and decided to continue until I was sure, it was actually a safe and effective method. http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

Press TV Print Page 2 of 6 Q. How did you get started in this project? Describe the different steps you had taken to achieve today's success. A. After following the first transplanted patients for a four-year period, I realized the treatment was ready to be brought out of the research phase and in 2005, I set up the company with the Shenzhen province government and the said Chinese university. It was not easy. Although China, with over 200 hospitals treating patients, is the most advanced country in clinical treatment using stem cells, there are many limitations and ideas making physicians and scientists stuck in their traditional and conservative ways of thinking like many other Western countries. However, a considerable number of Chinese physicians accept this treatment modality. Q. What are the diseases or injuries which benefit from stem cell transplantation; which operations are performed in your center? A. Our stem cells are provided at eleven major hospitals in China and one in Thailand. We mostly focus on neurological and vascular diseases. We believe the umbilical cord blood stem cells work best for spinal cord injuries, ataxia, cerebral palsy, and multiple sclerosis. They are not thought to be effective in stroke, in which amniotic membrane stem cells are considered to be the best choice. Other diseases with a high success rate which were less studied include autism, spinal muscular atrophy, and most recently optic nerve hypoplasia. Our achievements in treating optic nerve hypoplasia have been very exciting; as vision was restored in all of our four children cases treated with this technique. It is noteworthy that two of these cases were going blind. While many western doctors and scientists do not like to accept the achievements of Chinese scientists, they cannot deny the restoration of vision in children. The patients were blind and now they can see. We have focused on lower limb ischemia, in vascular disease cases. More than 800 patients have been treated using our peripheral blood stem cell and bone marrow techniques. Q. Are these operations performed routinely in other countries or you are the pioneers? A. There are many other stem cell treatment programs going on all over the world; a considerable number of the treatments have originated from Russia and spread to Europe, Central and South America. India has also proved itself as a center for this treatment. Our focus is to bring our treatment to all corners of the world including Romania, Hungary, Central America, and India. Q. Could you provide us some statistics to describe the situation of the research in this field, the number of operations performed and etc. ? A. Since 2005, over 2000 patients have been treated using our stem cell projects. Currently, we are treating about 150 to 200 patients per month; each month about 40 to 50 of these cases are foreign patients. We expect a considerable rise in the figure, as several other hospitals are going to get involved in the project. Hopefully, by the end of next year, we will be cooperating with about 20 to 25 hospitals. Currently, we have only 7 labs to give services to these hospitals; however, according to our good relation with the government's blood banks, we are looking forward to expand our http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

Press TV Print Page 3 of 6 services quickly. Having a laboratory in each city, in China or other parts of the world, is necessary for providing fresh stem cells fresh. Q. And your center, where does it stand? A. Again, we have eleven centers in China and one in Thailand. We treat foreign patients at four of these centers. Q. Is your technique the same as what is performed in other countries? A. We have the proprietary technology for our umbilical cord blood and amniotic fluid stem cells. Our scientists have been able to refine these techniques and protocols over the last five years. We think our umbilical cord blood stem cells are the best out there for the diseases we focus on. The scientists believe combining different types of stem cells instead of utilizing a sole type improves the outcomes. Our plan is to improve the outcomes in our patients instead of proving the effectiveness of a particular stem cell. Q. How many patients have undergone such an operation in your center until now? A. We usually do not perform surgeries except in rare cases of spinal cord injuries. Usually we use a combination of injections into the spinal cord fluid and Intravenous techniques. For lower limb ischemia cases we inject the stem cells directly into the leg muscles. So far there have been 2000 cases treated at hospitals using our stem cell technology. Q. How many of the operations have been successful? A. A satisfaction rate of 80% has been reported; however, it depends on the disease. As for lower limb ischemia, the success rate is much higher, while for a disease such as multiple sclerosis (MS) it goes down to about 70%. We evaluate the satisfaction rate because we focus on improving the patient's quality of life. A higher percentage of patients show significant improvements; however, the patients really do not care what the tests say. They just want to feel better. It is not rare to find a patient, especially with ataxia, who has a significant improvement especially in the Berger balance test scores but does not feel this improvement. Some western scientists may frown upon this but our focus is on getting patients better and not in proving that one particular type of stem cell works. This process does make them harder to patent. Q. What are the factors that influence the success rate? A. Patient selection can influence success rates. After treating a very large number of patients, we have a good idea which patients will react well to the stem cell treatment. Over time our success rate has gone up because we only take cases that hit our sweet spot. We do not treat Parkinson's cases, or the children older than ten years old with cerebral palsy. However, we will enroll the cases who insist, although they are told not to be suitable cases. There are several exceptions, in which we though the case was not a suitable one but to our surprise, the treatment have conversely led to a great improvement. http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

Press TV Print Page 4 of 6 Sometimes these patients ask what would happen if they had followed our recommendations; this is annoying. Q. Are there any criteria for defining a patient suitable for such operation/ predicting a patient to have a successful transplant? A. Yes. We have a detailed inclusion / exclusion criteria. To give some idea of the guidelines: we will not accept any patient who has cancer, hepatitis or HIV. We will not accept Parkinson's cases or children over 10 years old with cerebral palsy. We will not treat any patients on a respirator. Moreover, we generally do not like to accept patients with complete spinal cord injuries but there are exceptions. There are a lot more but I will not get into them here. Q. Is the patient's age decisive too? A. For children with cerebral palsy and autism, the younger the patients, the better are the outcome. However, there are always exceptions; there have been several older cerebral palsy patients who have had impressive improvements and some younger patients who had not achieved the expected improvements. For MS and ataxia, the disease's progress is more important than age. The treatment seems to give these types of patients about 20% improvement. If you are sitting in a wheelchair and you get 20% improvement, it may mean your legs are not too numb and you can lift them for the first time after years. Is this a great improvement in your quality of life? Maybe - but not as much as if you have the treatment in the early stages, which may help you walk without a cane or see like normal individuals. For optic nerve hypoplasia patients, the oldest patient that has been treated in our center has been 5 years old; but we are starting to accept older patients. We hope the 100% success rate in terms of improving vision will also be resulted as we slowly increase the patient's age. We are increasing the age criterion slowly as it is still in the early stages. Spinal cord injuries are very interesting as they seem to go against the 'earlier is better' rule. We have found that some of our best cases have been the patients who have had injuries for over 20 years. We have discovered a better response in these patients compared to those with an injury sooner than six months. As a result, except for the special cases decided by our medical experts, we generally do not allow the hospitals to accept the patients whose injuries have happened in the last six months. In general, if we do not need to use a patient's own stem cells, either bone marrow or peripheral blood stem cells, age is not so important. However, for vascular diseases in which we use the patient's own stem cells, we find it harder to obtain active stem cells from the older patients. Q. Is this operation also helpful in those with congenital disorders? A. The treatment repairs the dying cells, so in cases where a congenital disease causes nerve damage, it could also be helpful. Ataxia is a good example. We have many cases of hereditary ataxia. When the treatment helps one of the relatives, it almost always will help other family members as well. http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

Press TV Print Page 5 of 6 Six of our Canadian cases who had SCA2, were reported a significant improvement following the treatment. Q. Are there any specific complications reported following this operation? A. Because the patients get injections into the spinal cord fluid, we do see a lot of spinal headaches. Also, fevers often occur in children and some adults; however, this is not common and is only observed in 3.8% of the cases. It is interesting to note that I have asked many other doctors working in this field and they all believe developing fever is a good sign and is generally associated with good outcomes. A scientific study should be carried out in order to confirm this correlation. Q. What were some of the most rewarding and/or challenging moments you experienced in this project? A. The most challenging moment occurred at the beginning when we first started treating our foreign patients. The first two patients did not have any improvement following the third injection and assumed we were cheating them. One decided not to continue with his last injection. A key person in our project, Jonathan Hakim, almost quit during this time because he felt so bad about the patients without improvement. However, once the third patient showed improvement, everything changed and the other two asked for as many stem cells as they could get. These cases experienced some improvements after they returned home. The most rewarding moments come every time we see the face of a patient who shows improvement. This is not only because of seeing little improvement in them but also because of the change made to their attitude towards life. Q. What encourages you to continue this project? A. We help patients every day and they are thankful; this makes me continue my research in this project. We cannot tell you how many people have thanked us for changing their lives. On the other hand, we meet people from all walks of life and from different countries. There is very little opportunity to do this in normal business. We have treated patients no matter rich or poor, from various nations and ethnic backgrounds. We have even had patients from Iran. In addition, we are now starting to compete internationally in different fields from basic research to clinical treatments. We actually have the chance to be the leading stem cell research and treatment company in the world. This is exciting. Q. How do you see the future of this field? What would be its place over the next ten years? A. Stem cells are going to completely change the way we think about medicine and preventing the aging process. We are going to start living a lot longer thanks to stem cells and this is going to influence almost every aspect of the life. This technology is very young and we are experiencing many amazing things. The industry itself is going to make more money than the IT industry has had in the last 20 years. Q. Do you have any specific comments or advice for our readers. http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

Press TV Print Page 6 of 6 A. It is very important to ask from as many patients as possible to ensure the safety and effectiveness of the technique used in a treatment center where you are planning to have your stem cell treatment there. Transparency is important and with the help of the Internet, useful information could be gathered quickly; even through reading patients' blogs, watching videos, and participating in discussion groups. To see an example of our efforts of transparency, you can go to http://www.stemcellschina.com. PKH/RE Count of views : 3159 © Press TV 2007. All Rights Reserved. http://www.presstv.com/pop/print.aspx?id=30720 3/26/2008

A revolution in Chinese stem cell technology

by Patricia Khashayar on Aug 29, 2009

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A revolution in Chinese stem cell technology Document Transcript