Stem Cell Therapy Today in the People’s Republic

· April 28, 2009

President Obama’s recent U.S. stem cell policy reversal allows federally funded researchers to use hundreds of new embryonic stem cell lines. "Our government has forced what I believe is a false choice between sound science and moral values," Obama declared as he signed documents changing U.S. science policy in March 2009.

The U.S. is a bit late to the global stem cell research game. Japan’s Dr. Shinya Yamanaka demonstrated the ability to reprogram adult cells to behave as embryonic stem cells as early as 2007. But it is in China’s Guangdong Province that there have been almost miraculous strides in actually using stem cells to treat and cure diseases such as blindness, cerebral palsy, and spinal cord injuries.

Dr. Sean HuDr. Sean Hu is a soft-spoken powerhouse of a man who holds both an M.D. from China and a Ph.D. in Biochemistry and Molecular Biology from Gothenburg University in Sweden. The company he founded, Beike (bei-ker) Biotechnology, is one of the leading players in stem cell therapy. Headquartered in Shenzhen – not far from Hong Kong – Beike has become a therapeutic refuge for a fast-growing number of patients seeking stem cell treatments.

h+: Dr. Hu, what brought you, a Ph.D. biochemist and medical doctor, to the stem cell industry?

SH: After I finished my postdoctoral work in Canada in 1999, I stopped doing research and started running a couple of businesses in China – importing dental equipment from the West and running a hospital management consulting company at the same time. This gave me the opportunity to work with hospitals in China.

From 2000 to 2001, China’s stem cell research was still poorly funded. James Thomson published his breakthrough work creating embryonic stem cell lines from human blastocysts in Science Magazine in 1998, which kicked off a race for funding in the West. After seeing the first successful Chinese case treated with stem cells at Zhengzhou University Hospital in 2001, I decided to get involved with the research. I was interested in taking laboratory bench work to the hospital bedside. I think that cell-based therapy has a lot of potential because most of the biological activities in our bodies occur at the cellular level. In 2004, after three years of clinical studies observing more than 100 cases, I decided to build a company to supply and work on safe adult stem cells.

Regenerative medicine is the future. Asia will be at its center.

h+: What are Beike’s most successful cases?

SH: As of February 2009, Beike has treated over 5,087 patients with cord blood stem cell injections for diseases like ataxia, autism, ALS, brain trauma, cerebral infarction, cerebral hemorrhage, cerebral palsy, diabetics, Guillain-Barre, encephalatropy, and spinal cord injury – many of these are considered incurable diseases.

There have been many successful stories of stem cell therapy (SCT). One example is the recovery of a nearly blind sixteen-year-old girl, Macie Morse, who recently got her learner’s permit and started driving. She came to one of our hospitals for treatment in July 2006, with 20/4,000 vision in one eye and only light perception in the other due to optic nerve hypoplasia. After treatment, Macie now has 20/80 vision in one eye and 20/400-plus in the other!

h+: Have there been any mistakes that you could share with us and explain what was learned from them?

SH: Mistakes have occurred when we don’t screen our patients effectively. SCT works well for some diseases but not in others. For example, we’ve learned from experience that SCT has very little effect on complete spinal cord injury even though it can improve partial spinal cord injury. Also, the effect of SCT on ALS (Lou Gehrig’s Disease) patients is transient and short-lived – patients have to come back regularly for additional treatment. Currently we are focusing on brain injury, cerebral palsy, ataxia and other optic nerve damage, lower limb ischemia, autism, spinal muscular atrophy, multiple sclerosis, peripheral vascular disease, diabetic feet, and others.

h+: SCT cases in 2006 cost around fifteen to twenty thousand dollars USD for an initial treatment. Costs have increased since then. Do you see this as the result of currency fluctuation or will costs continue to increase for other reasons?

SH: Currency fluctuation has definitely contributed to the cost increases. For example, in 2006, one US dollar equaled 7.8 Chinese yuan; in 2008, one US dollar equaled 6.7 Chinese yuan.

Meanwhile, Chinese companies are still buying cytokines (polypeptide regulators) from the West. It would be cheaper if we had home-made cytokines in China. But this is not going to happen soon because the market is not big enough for high volume cytokine production. Of course, the higher cost is also a result of Beike supporting hospitals to improve their equipment, service, and environment. In addition, we’ve been hiring experts to improve the protocols. These include overseas professors from well known universities like Stanford. This means we need to match the salary levels with those in the West.

h+: What’s the percentage of patients who actually go back for further treatment?

SH: About 20%. The cost is still too high for many of them because it is not covered by insurance. In almost every case, if the treatment works for the patient the first time, repeat treatments will also be effective. Some of our patients have returned four or five times for more treatment.

h+: What’s the average cost for each additional treatment?

SH: The same as the initial treatment.

Stem Cell Therapyh+: Many of your patients keep a blog to share their experiences. Does Beike use any of these blogs for case study? Does Beike keep track of the patients afterwards?

SH: It’s hard to get any concrete information from the blogs. But we do post evaluation medical forms and satisfaction forms to monitor the patients. We are starting to collaborate with some hospitals in the U.S. for single blind studies. We have third party doctors to compare patients with the same disease that went through different treatments – with or without stem cell therapy. The third party doctor doesn’t know what kind of treatment the patient went through. They test the treatments equally.

We also plan to do stem-cell-only treatments for some visually impaired patients. We want to find out if stem cell therapy by itself is sufficient to make a change. Because right now, most of the treatments done in our clinics are holistic: they combine stem cell therapy with an injection of nerve growth factor, acupuncture, and rehabilitation therapy. For our first forty foreign optic nerve hypoplasia and septo-optic dysplasia (ONH/SOD) patients, we required each to go through intensive testing from their local doctors before and after the treatment. We were able to prove to ourselves that the treatment was working. This has given us the confidence to go forward and invest money to expand into the western markets.

h+: What happened to that first patient who you visited at Zhengzhou University Hospital in 2001? That’s eight years ago now.

SH: She’s a retired teacher in her 60s. She’s doing fairly well. After the first treatment, she went through a few more treatments for her ALS every few months.

h+: What’s the major challenge for your company currently? What’s the major challenge for the stem cell industry in China?

SH: We’re a China-based stem cell company. Our major challenge is the U.S. FDA standard. For the time being, the U.S. and Europe hold the majority shares of the market because the cost for treatments is still too high for developing countries. We want to build our clinics and labs there. We are working on improving our levels to meet international standards such as the Declaration of Helsinki, the Council of International Organizations of Medical Sciences (CIOMS), the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the Guidelines for Good Clinical Practice from the World Health Organization (WHO) and The International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. It will take time and lots of financial support. Technically speaking, we are confident and optimistic because we have developed a very diverse technological base. However, China is facing a shortage of comprehensive expertise that has experience in clinical study, stem cell research, as well as the therapeutic industry.

h+: Who are your biggest competitors? Who is doing the most interesting new research that you’re following?

SH: Osiris in the U.S. is our biggest competitor. We are way ahead of most of the Chinese stem cell companies. Although, Beijing Keyu is one of the pioneers in stem cell therapy research and Tianjin Xiehe has a very impressive storage facility. Zhongke is catching up as well.

h+: What are your thoughts on Geron’s FDA approval in the U.S. last month? Will that create more pressure on Beike? Is Beike also seeking FDA approval?

SH: I think Geron’s FDA clearance to begin the world’s first human clinical trial of embryonic stem cell-based therapy is great news for the entire stem cell industry. More competition is inevitable. The stem cell industry is becoming more competitive. To excel, Beike has established a Stem Cell Expert Advisory Committee and a separate Data and Safety Monitoring Board (DSMB) to oversee future Beike-sponsored research. We are currently conducting international level clinical trials. We are not yet in the process of applying for FDA approval, but we’re starting to prepare.

h+: What are your thoughts on China’s regenerative medicine industry? Is Beike currently working on any projects related to regenerative medicine?

SH: Regenerative medicine is the future. Asia will be at its center. More and more western scholars and doctors are coming to China to collaborate. We have signed an agreement with AELCELL of Stanford University and the University of Texas Health Science Center at Houston. Right now, we are able to grow human organ cells from isolated stem cells.

h+: What are your thoughts on healthy, radical life-extension (living beyond the current 120+ age limits)? Will the stem cell industry play a major role in life-extension? Will Beike get involved?

SH: Yes, stem cell therapy will play a major role in life-extension. From what we’ve learned, the positive side effects of our treatments include patients sleeping better, improved appetite, and more robust hormone regulation after the treatment. The potential of stem cell therapy in anti-aging is enormous. Beike is definitely looking into this. For now, however, we want to focus on improving our treatments for incurable diseases.

h+: The U.S. and the Chinese government face the stem cell issue very differently, especially for embryonic stem cells. Do you think that the Chinese government is giving this industry enough support?

SH: In the past few years, the Chinese government has invested substantially in stem cell research. However, funding is still quite limited. Even though we don’t have religious interference, our government’s science policy has yet to catch up. There have been talks about forming a stem-cell-related committee in the central government.

h+: How do you feel about the research environment in China? Do you have difficulty finding the kind of academic support that you need? Do you have difficulty getting material support such as equipment and chemical solutions?

SH: The research environment in China is still behind. The communication between scholars is still very limited. However, we no longer have difficulty getting material support from overseas. Last year, we hosted China’s first ever symposium on advanced iPS (induced pluripotent stem cell) research as well as the first annual China Stem Cell Technological Forum. We hope to bring the Chinese closer to the international community.

h+: What’s the biggest lesson you’ve learned in the past three years? What would you do differently now?

SH: After all these years of observation and practice, I consider adult stem cell-based therapy to be safe. I believe it will become one of the major players in medical industry because it overcomes the single molecule limitation (manipulating single molecules at the molecular level).

Would I do it differently? Not much, I think. Beike did not go through the traditional path of a typical biotech company because it would have been too costly for us. But the value to everyone in the company – helping so many patients improve their quality of life – has been priceless.

h+: Where do you see the company in five years? In ten years?

SH: We are building Beike to become a first-class international conglomerate in three areas:

  1. We will set the standard and criteria for R&D in developing adult stem cells and iPS. We will have one of the biggest iPS centers of the world.
  2. We will have one of the biggest Good Manufacturing Practice (GMP) standard international clinic and laboratory networks.
  3. We will have one of the biggest stem cell banks of the world.

Currently we have permission from the governments of Turkey and India for clinical practice. We are expanding our network in Eastern Europe (starting in Hungary and Romania) and Central America (Panama). Eventually we will come to Northern America and Central Europe. Last June, we set out to build a 21,500 square foot comprehensive Jiangsu Stem Cell Storage Facility which will become one of the most highly developed of its kind. It will facilitate the storage of human umbilical cord blood stem cells, placenta stem cells, amniotic membrane stem cells, bone marrow stem cells, and also iPS – which will come soon.

h+: Do you have plans to take Beike public?

SH: Yes, after the markets recover and our iPS research matures. Currently, we are founded with capital from Beijing University, Hong Kong University of Science and Technology, Shenzhen Municipal Government, and the China State National Fund.

h+: An article in last week’s PLoS Medicine describes a teenage boy’s brain tumor after receiving a fetal stem cell treatment in Russia. Has Beike encountered anything similar? Do you do follow-up research on your patients?

SH: I haven’t read the article yet, but it depends on the type of stem cell they injected into the patient. The adult stem cells we use are safe. We haven’t encountered a similar case in the past eight years. Meanwhile we’ve established a world-class research hub that is focusing on cell reprogramming and gene engineering – in the hope of discovering new treatments for diseases like cancer.

 

5 Responses

  1. Brian says:

    This article should be labeled “ADVERTISEMENT.” The writer states that Beike has made “almost miraculous strides in actually using stem cells to treat and cure diseases such as blindness, cerebral palsy, and spinal cord injuries.” However, she provides very little support for such a sweeping statement. Beike has published very little, just a few articles in Chinese journals describing a few cases studies. Patient testimonials – such as those on the Beike-sponsored blogs – are not considered valid evidence of medical efficacy by anyone in the medical world. The placebo effect is so strong – especially in a case where a family sacrifices so much to raise money and travel around the world – that it’s impossible to know what improvements are real and what are placebo. Beike might be onto something promising, but they need to start running some clinical trials and publishing some real data.

  2. tehseen ullah says:

    i have spinal injury T6T7 complete pra i want my treatment now plz send me cost of the treatment

  3. Anonymous says:

    This article should be labeled “ADVERTISEMENT.”

    This is a good suggestion. Hu is a totally quack. His so-called stem cells made by his bompany is a mix of unknown cells. No quality control, no any liscence from the Chinese authorities.

    He mainly treat patients with nerve injury. As we know, patients with nerve injury some times recover on their own without any treatment. So the “successful” cases boasted by them are unbeilvable. Only controlled, blinded, and large-sacle clinical trial can support the effects of any treatment for brain or spinal injury and any nerve disease.

    see: nature mazine report
    Stem-cell therapy faces more scrutiny in China The Chinese Ministry of Health has implemented regulations on the clinical application of cutting-edge therapies such as stem-cell injections. Stem-cell scientists in China contacted by Nature hope that the rules may help to curtail a growing trade in unproven treatments that attract patients from around the world, risking their health and potentially damaging the reputation of stem-cell research. The new regulations, which came into effect on 1 May, designate all forms of stem-cell therapy as ‘category 3′ medical technologies — those deemed “ethically problematic”, “high risk” or “still in need of clinical verification”. The ministry will take direct responsibility for regulating all category-3 procedures, which include gene therapy, surgical treatment of mental disorders or drug addiction, and sex changes. Institutions wishing to offer stem-cell therapies must first demonstrate safety and efficacy in clinical trials; the treatment will then be assessed by a ministry-approved regulator. Institutions failing that process must wait 12 months before reapplying. Although the penalties for not adhering to these rules have not been made explicit, institutions that transgress are likely to face fines or have their permit to practice medicine revoked, says Renzong Qiu, a bioethicist based at the Peking Union Medical College in Beijing. “These regulations will make people understand that the Ministry of Health and many scientists in China are concerned about these unverified procedures,” says Ching-Li Hu, a paediatrician and senior adviser to Shanghai Jiaotong University’s medical school, and a member of the International Bioethics Committee of the United Nations Educational, Scientific and Cultural Organization. Hu and Qiu are members of an expert panel that will deliver recommendations to the ministry later this year on how to implement the regulations effectively. Murky area China already has experience in regulating cutting-edge technologies by assessing clinical trials and conducting ethical reviews. It was the first country to give governmental approval for a gene-therapy treatment, one produced by SiBiono GeneTech in Shenzhen that targets head and neck cancers. But stem-cell therapy is a murkier area. Some researchers worry that medical institutions will be able to circumvent the regulations by calling their therapies research, even though they are charging patients and not carrying out the rigorous monitoring required by clinical-trial protocols. If those institutions have sought official approval, it comes from local governments or institutional review boards, which do not have the expertise to properly assess the treatment, says Hu. From interviews with scientists and physicians, Qiu estimates that there are 100–150 clinics claiming to offer stem-cell therapies in China. But it is not yet clear whether companies supplying the stem cells will be also be subject to the regulations. Shenzhen-based Beike Biotechnology is China’s most prominent stem-cell therapy company, providing adult stem cells and umbilica The foundation offered to help Beike set up a clinical-trial protocol that would include creating a registry of patient outcomes. Joseph Cosico, the foundation’s vice-president for research operations, says that Beike declined the offer “because of their inability to fund the venture”. Beike says that it decided to work with another group, partly for cost reasons, but would not provide any details of that collaboration. “I can understand why they wouldn’t want to do a trial,” says cell biologist Duanqing Pei, director-general of the Guangzhou Institute of Biomedicine and Health. “They might spend millions of dollars to prove that the treatment isn’t effective.”

  4. Anonymous says:

    What a hatchet job this comment is. It sounds like someone who has been drinking Wise Young or Doug Sipp’s Kool Aide. When a person has been flat on his back for 11 years, from age 17-28 and can only rotate his hands and then after a series of stem cell treatments he can now hold himself up in a sitting position, raise his hands above his head, control his bowels and regained almost complete feeling to his feet, this commenter want you to believe it has nothing to do with the stem cells.

    He says “with nerve injury some times recover on their own without any treatment,” as if this might be the reason after 11 years of no progress with regular PT and other treatments. This young man would laugh in your face it is so absurd. “Only controlled, blinded, and large-sacle clinical trial can support the effects of any treatment for brain or spinal injury and any nerve disease.” Again, the audacity of such a statement!! Maybe you want to go back to school and learn how to spell “sometimes” and “license” and then take a class on critical thinking.

    These people are doctors and scientists and are offering treatment to some of the sickest and most desperate people and sometimes it works and sometimes it doesn’t. These are dedicated people offering the kind of care you have never seen in the US and they are not getting rich doing it. Why do you think a person dedicates their life to helping others? Just to make money like in the US? You are using your own warped lens to judge others. And I defy anyone to show where any harm has come and there are literally hundreds of people who have had marked improvements. But if this is true, what happens to some of the research money going to the institutions in the US? Is there any conflict of interest when Wise Young is scrambling to raise money for his research and saying derogatory things about other companies with which he is in competition?

    Arrogance and ignorance are a deadly combination and the commenter has displayed both. Arrogantly thinking he knows something when it is merely his own theory, and ignorance for ignoring the facts surrounding a number of patients whose lives have dramatically improved. But we are to believe that it just coincidentally happened when the nerves decided to respond at the same time of stem cell treatments and that it would have happened anyway without the treatments. And how about all those drugs in the US that the backscratching between FDA and Big Pharma have been approved and have killed thousands like Vioxx? Or the more than 100,000 people every year that are killed through bad treatment at US hospitals? You probably think the US still has the best health care in the world even though every survey shows it considerably down the list.

    You live in a fantasyland that is misinformed by the mainstream press and by people who have a vested interest in holding back these advances. First you might want disavow yourself of the idea that Santa Claus and the Easter Bunny are real. After that, I have a bridge in Brooklyn that I can get you for a really good deal.

  5. Lily says:

    You are misguided. Nature is made up and supported by every scientist who has everything to lose by people getting treated with the same stem cells that Beike is using. Basically an article by Nature is like letting Iran write an article about the US and giving it an air of impartiality. Stem cells as they are do help patients but it is very hard to make money off of. This is an economic and political war and the patients are the ones that are losing. It seems that our pets are okay to treat with stem cells and they do very well but when it comes to humans where the money is, then we are going to have to wait until all of our friends at Nature make the money.

    You are either one of the people who are working with the establishment and don’t care about people’s health or you are just a blinded idiot. I tend to go with the idiot theory.

    By the way, the cells are very well known as they are no different than the cells that are used to treat blood diseases in the west. Now you can see why it is so threatening to all your friends.

    Lily

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