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STEM CELLS CHINA - BEIKE
 

Laurance Johnston, Ph.D.

In my search for function-restoring therapies for spinal cord injury (SCI) or dysfunction, I’ve visited numerous cell-transplantation programs emerging throughout the world. As a continuation of these efforts, I recently traveled to China to check-out Beike Biotechnology’s stem-cell program. An UK’s Times newspaper article selected Beike (pronounced Bay-Ka) as a runner-up company on its list of the “Top 10 Chinese firms that will challenge the west.” (March 9, 2008)

Beike

Beike was founded in 2005 with funding from Beijing University, Hong Kong University of Science and Technology, and Shenzhen City (near Hong Kong), and nurtured with Chinese government grants. The company has established collaborations with 60+ scientists at leading Chinese universities. Building upon a base of research starting a decade ago, Beike-affiliated doctors treated their first patient in 2001; and in several years, had treated hundreds with a variety of disorders. As confidence grew, they established Beike to treat patients with stem cells on a commercial scale.

Since then (12/08), they have treated ~3,900 patients at about 30 clinics in China and one in Thailand, about 800 of which came from 35 other countries. Over a third of the patients had spinal-cord dysfunction, including SCI (1176), MS (103), and ALS (194); and 77 had traumatic brain injury.

Technically, however, Beike does not treat patients. Through their 18 laboratories located throughout China, the company provides stem cells to collaborating hospitals. It is the hospitals who have been granted the authority from the China Ministry of Health to treat patients in Beike-established clinics. Although many Chinese hospitals provide stem-cell therapy, Beike is the country’s largest stem-cell source. Overall, stem-cell therapy is much more accepted in China. For example, is not uncommon for the more connected to periodically “shoot-up” with stem cells for rejuvenation sake.

To make the therapy more internationally accessible, Beike will be establishing laboratories and treatment centers in India, Europe, Middle East, and either Panama or Mexico.

Visit to Clinics

My multi-city visit was hosted by Beike’s Director of International Affairs, Jon Hakim, who grew up in my home state of Minnesota and whose father had been a physician at various Minnesota hospitals and had treated Vice President Hubert Humphrey. Jon’s heartland background combined with his Mandarin fluency and Chinese work experience minimized the cultural gap. In addition, many Chinese doctors and scientists knew some English from working abroad. As author Marshal McLuhan predicted, we have, indeed, become a “global village.”

I was astonished by China’s continued growth and development since my last visit in 2001. Much of the country seemed to be a high-rise construction zone; expressways were clogged with stop-and-go traffic; and shoppers scurry around buying Christmas gifts.

I visited Beike clinics in three cities, Qingdao, Hangzhou, and Shijiazhuang, as well as Beike-affiliated scientists in Beijing. Of these clinics, Americans tended to go to either Qingdao or Hangzhou. Eventually, however, patients will be assigned to clinics based on the specific disorders the clinics are most proficient in handling.

The clinics were located in a wing or floor of a collaborating hospital. The suite-like rooms were spacious and modern (e.g., flat screen TV’s, DVD players, Internet access, etc.) with beds for caregivers. In each clinic, liaisons fluent in English helped patients with their needs. Because Chinese names can be confusing for Westerners, staff usually adopted a Western moniker. For example, the Hangzhou clinic patient liaison was Rebecca, a recent English-literature major (photo with author). The Shijiazhuang liaison was Stanley, who had worked for a Mediterranean cruise ship line.

By the Yellow Sea, Qingdao hosted the 2008 Olympic sailing events. Its downtown strip was a Chinese “Riviera” with beaches, fancy restaurants, and luxury shopping. The city is the home of China’s famous Tsingtao beer (a western derivation of Qingdao), a German-recipe brew that came out of the 19th century German occupation of the city. The clinic itself is located in a hospital further out near the airport (Click on thumbnail). Shops and restaurants under construction by the hospital will provide opportunities to do nearby activities. 

South of Shanghai, Hangzhou is a prosperous, modern city with beautiful lakes and natural scenery. It is visited by many Westerners. Because Hangzhou is further south, the city is warmer in the winter. The Hangzhou clinic had a good ambience that fostered patient interactions and was close to shops and restaurants.  

About 200-miles southwest of Beijing, Shijiazhuang is a more industrial city that greatly grew after the founding of the People’s Republic of China in 1949, and, until recently, has been off the beaten track for Westerners.  Clinic patients were primarily from Eastern Europe, the Middle East, India, South America, and Australia. Beike staff generally picked up patients at Beijing’s just-built international terminal, a four-hour drive away.

For readers interested in clinic life, check out the numerous patient blogs posted on www.stemcellschina.com.

Stem-Cell Review

Stem cells encompass a continuum of cell types that transform into our end-product tissue. As our central nervous system (CNS) develops, embryonic stem cells evolve into more specialized tissue-specific, neural stem cells. Adult stem cells are found in most tissues, including, for example, CNS, bone marrow, skin, intestine, liver, muscle, hair follicles, and even teeth. Sometimes, they are robustly expressed, such as the bone-marrow’s ongoing production of blood-cell-replenishing stem cells; in other tissue, they are quiescent.

Transplantable cells can be obtained from the patient (called autologous); genetically different individuals, embryos, or umbilical cords (allogeneic); or different species (xenogeneic). All three types have been implanted by various programs to restore function after SCI. Because autologous tissue is patient derived, there is no immunological rejection. The undifferentiated nature of embryonic and, to a lesser degree, umbilical cells also minimizes rejection.

Donor cells are transplanted back into the patient by a variety of routes, including into the spinal cord or surrounding fluid, intravenously, or intramuscularly. Although it’s easier and safer to inject cells into a muscle, blood, or spinal fluid than surgically accessing the cord, it may not be as effective. Many devil-is-in-the-details questions remain regarding the ultimate deposition, fate, and survivability of stem cells transplanted by divergent routes.  

With SCI, it is unclear how functional improvements are physiologically mediated. The implanted stem cells may become new neurons or support cells; or alternatively, secrete growth factors or other substances that augment the function of surviving neurons, or create an environment more conducive for regeneration.

Commercialization

Many stem-cell programs have grown beyond their more altruistic, academic research roots and have become economically driven. Without a doubt, there is big money to be made in stem cells, which is not necessarily bad. Like all biotech and pharmaceutical company products, such economic motivation is needed if real-world, stem-cell therapies are to emerge. Nevertheless, at this stage, caveat emptor for individuals considering any stem-cell program. Prospective clients should carefully weigh potential treatment pros and cons relative to their unique situation, including costs.

Beike stresses upfront that no benefits may accrue; clients should have realistic expectations. Because every injury and person is different, responsiveness to any therapy, stem cell or otherwise, varies considerably.

Beike Stem Cells

Beike transplants a variety of stem cells by different routes. Frequently, the company uses umbilical cord stem cells, in part, because cord blood is commonly collected after birth by Chinese blood banks. Beike also transplants stem-cells obtained from the patient’s bone marrow. Cells are usually transplanted either intravenously or by lumbar puncture, the latter which introduces the cells directly into the CNS. Occasionally, cells have been implanted directly into the spinal cord.

After testing for diseases, the cord blood is transferred from the blood bank to a Beike laboratory and retested. Stem cells are separated from blood cells and platelets through centrifugation and then cultured in a media containing growth factors, which enhance rejuvenation potential. The growth media is washed away, leaving the desired stem cells. To ensure viability, all stem-cell preparations are fresh and not frozen for later use.

Typically, patients receive 4-7 stem-cell injections over a 25-35 day period. This treatment regimen is supplemented with individually tailored, rehabilitation programs.

SCI

Many Beike-treated patients with SCI have regained life-enhancing benefits, ranging from the subtle to fairly dramatic. Cumulatively, even little gains have made a big difference in post-treatment quality of life.  In addition to the stem cells, some improvement is probably due to the patients’ concomitant initiation of aggressive physical rehabilitation.

Although improvements with some disorders may fade over time, SCI gains seem to be enduring. Consistent with more long-term physiological mechanisms, benefits often slowly kick-in after stem-cell treatment and returning home. Functional gains seem to be greater for individuals who have been injured for longer periods of time.

Study: Beike scientists have evaluated the effects of treating 500 patients with umbilical-cord-blood stem cells (465 completed the study). Patients were 18-65 years old, 78% were men, and all had been injured 1-10 years before treatment (C4-T10 injuries).  Patients received 4-5 intrathecal injections containing 10-30 million stem cells at one-week intervals and followed for a year using several evaluation parameters, including commonly used ASIA assessments (American Spinal Injury Association) for motor function and sensation. Statistically significant, modest improvements were documented which continued after the final injection. No serious side effects observed.

Based on the findings, Beike investigators will soon be initiating in India a more rigorously designed, randomized, placebo-controlled trial.

Patient Experience

Beike has treated more patients with SCI than any other disorder. Many of the patient experiences are posted at www.stemcellschina.com, including before-and-after-video documentation.  

For illustrative purposes, I’ve included Gabi’s experience. A 30-year-old Romanian, who was one of Beike’s first foreign patients, Gabi sustained a C5-6 incomplete injury in 1995 from a diving accident. After three sets of stem-cell injections, Gabi posted the following [English edited]:

“My hand movements are much better. I have more power in my hands and body, and new sensations all the way down to my feet, almost 90% … I feel my hands 100% now.”

“I’ve started to move my fingers a little and can feel pain in my first two fingers. I also can feel a lot of heat in my legs, and…can move my feet, but only 1-2 times. Now, I can contract my stomach muscles. I can stay on my feet 30-50 minutes, but with assistance and support on my knees. I have more stability than before, and when I’m on my feet I can move my hands and body more because my abdominal and back muscles are stronger.”

When lying in bed, I can move my feet a little … I can hold my urine for 5-10 minutes before I have to go. My sensation is much improved; I can feel better my legs and all my body for temperature, as well as pain and touch (skin) sensation…My stability is much better than before, I can sit on the bed without support, and if my mother pushes my legs forward, I can move them back. So, now I have started to move my legs; even if it is a little, it’s a start. My triceps have started to work too.”

Patients I specifically met during my visit included Cheryl who sustained a T12 complete injury five years earlier from falling off a horse; and Leslie who was injured 12 years previously from a diving accident.  Both had returned to China for a second set of treatments and have patient blogs. Cheryl reported improvements in bowel and bladder function, and muscle control and sensation in legs. Leslie had a considerable reduction in the chronic pain that had plagued her since injury. (Photo: Leslie with author, mother, and clinic doctors)

Conclusion

A recent article in a scientific journal noted that beneficial claims promoted over the internet by many stem-cell clinics represent over-hyped, economically driven marketing and are not supported by sufficient peer-reviewed studies. Although I agree with many points, the article demonstrated one of the scientific community’s quintessential weaknesses: the authors didn’t bother to talk to any patients. Essentially, the authors just relied in one form or another on the opinions of like-minded Western scientists (i.e., another definition of peer review).

Although people with SCI are demanding real-world solutions now, scientists believe the best way to develop these solutions is an allegiance to what many with SCI consider a glacial, trickle-down scientific process. Through searching the internet, people with SCI increasingly get glimpses of what is possible and don’t want to wait until science’s liaise-faire approach produces a thumbs-up approval at some distant point in the future.

It doesn’t have to be like this. If we are flexible, there are ways to reduce the scientific and regulatory hurdles to speed-up the development of safe and efficacious approaches for restoring function after SCI. One of the easiest is to open-mindedly establish bridge-building collaborations with investigators, programs, or clinics in other countries.

Adapted from article appearing in March 2009 Paraplegia News (For subscriptions, call 602-224-0500) or go to www.pn-magazine.com

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