Dr. Sean Hu is the founder and chairman of Beike Biotechnology, a Chinese stem cell research and treatment center. Beike has treated over 2,000 patients using stem cells for diseases like multiple sclerosis, cerebral palsy, and limb ischemia. The success rates vary by disease but are around 80% on average. Dr. Hu believes stem cell therapy will revolutionize medicine in the future by helping people live longer and altering many aspects of life.

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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.
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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
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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.
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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.
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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.
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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
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