Stem cell therapy technology immature patients pay for "dedication research"

China Education Equipment Purchasing Network News: The current medical level is more and more developed, but the treatment methods resulting from commercial investment and related public opinion are also emerging. Stem cell transplantation technology treatment is still in clinical research stage in China. However, with the intervention of commercial capital, from the acquisition, preparation and production of stem cells to the treatment of hospitals, a complete industrial chain has been formed. The profit of each link is ultimately paid by patients who are dedicated to research.

Fierce capital

Beike Bio was established in 2005. In 1999, founder Hu Xiang discovered that stem cells had "promising prospects", decided to start a business, and began to gradually build a business transformation platform.

In the Hu Xiang model, Beike Biology has mastered some core technologies of stem cells by cooperating with domestic and foreign research institutions, and combined them with hospital clinical treatment.

The publicity and promotion carried out by Beike in the cooperative hospital has made stem cell transplantation not only serve the patients, but also made the hospital obtain a considerable benefit in return.

With the approval of hospital clinical research issued by health departments at all levels, the mutually beneficial business model of Beike Biology and partner hospitals quickly took root.

"If it is done according to traditional medicines (requires phase III clinical trials), there are companies in the United States that burned hundreds of millions of dollars in 12 years. But Beike has already made good profits (50 million yuan) in only 3 years, which are all established In terms of business model innovation. "Hu Xiang is very satisfied.

The comparison cannot be so simple. Because the US FDA will never allow medicines and medical technologies to charge patient fees during clinical research trials. On the contrary, they will have to pay related fees.

In China, stem cell banks established by commercial companies and cooperative institutions are just one of the sources of high profits. At present, umbilical cord stem cell banks can be divided into public banks and private banks. The former is invested by the government and the latter is paid by customers.

The listed company ST Zhongyuan owns the largest stem cell bank in China. In the first half of 2011, a generous investment was made, with a plan to issue an additional 457 million yuan to acquire the well-known stem cell clinical transformation company, Heze Bio. Within six months, the stock's stock price soared from 10 yuan per share to 27 yuan, up 174%. Investors' dedication to the commercialization of stem cells is evident.

It is precisely due to the involvement of private capital from various backgrounds that the "Beijing-Hospital Model" was replicated on a large scale; many hospitals saw huge profits and began to organize their own production of stem cells.

"Combine a few technicians and buy some instruments. It's a new company and it will be produced immediately." Said a person in charge of a stem cell company in Beijing.

The temptation of high fees

Director Xing still did not appear in the 261 hospital. At the moment, Zhang Mingliang, who has seen a silver lining, still has doubts about the efficacy of stem cell therapy. The on-duty doctor told him that the stem cell therapy technology is an emerging technology that has curative effects on liver disease, cerebral palsy, and diabetes. They have been used clinically since 2007 and have done thousands of cases.

Regarding Zhang Mingliang ’s concern about the safety of the new technology, the hospital said that they have followed up thousands of cases, and none of them have safety risks.

"Our hospital has its own stem cell culture room. Although there are many stem cell treatment hospitals, our advantage is that stem cells are derived from fresh umbilical cord blood; the number of stem cells in the center can reach 10 to the 8th power, which is higher than many hospitals. Naturally good. "The physician continued to dispel Zhang Mingliang's doubts.

"A course of treatment is about half a month. In the middle, the lumbar puncture is through the spinal canal (through the brain), and the vein is reinfused three times. Simple stem cells are about 40,000 yuan, plus other treatment expenses, it should not exceed 50,000 yuan. Fang answered Zhang Mingliang's question about fees.

In addition to cerebral palsy, the scope of stem cell treatment in the 261 hospital also includes diabetes, bone marrow injury and cirrhosis.

Zhang Dongsheng (pseudonym) from Liaoning is a patient with severe cirrhosis. While Zhang Mingliang was wandering in the 261 hospital, he aimed at stem cell therapy at the 302 Hospital Liver Disease Biotherapy Center.

Zhang Dongsheng was lucky. Among the nearly 100 hospitals in Beijing that are carrying out stem cell transplantation, 302 Hospital is almost the only one that does not charge.

The staff of the center told Zhang Dongsheng that 302 stem cell transplantation of liver disease is limited to severe cirrhosis, ascites and acute liver failure, which is a clinical research trial. Not all patients can participate, depending on whether the symptoms are adapted.

If it passes the preliminary review, each volunteer patient only needs to pay a deposit of 3,000 yuan to sign an informed and voluntary agreement. After a free course of treatment, a 1-year clinical follow-up is required. If it is effective, you can continue to participate in free transplantation after one year.

For this clinical study of stem cell treatment of liver cirrhosis, the center has directly invested more than 8 million yuan in scientific research, excluding auxiliary costs. Over the past three years, thousands of volunteers have undergone stem cell transplantation, and none have been charged.

Wang Fusheng, a professor at the center, is a well-known expert in the field of liver disease stem cells in China. He is also one of the host of the conference on cell therapy technology. Wang Fusheng did not want to comment on the commercial operation of stem cells. But he has his own standards. "We (the center) have the approval of the Ministry of Health in the army, but it is limited to clinical research, not clinical application."

Transboundary treatment

"Is it not qualified for treatment, and dare not collect money? Is the technology pass?" Some patients came to the 302 hospital with suspicion.

These patients may not even think about it. There is no hospital in China that is qualified for clinical application and treatment of stem cells. All currently approved are clinical research projects.

"Even research qualifications require in principle the approval of the Ministry of Health ’s Department of Science and Education. Of course, military hospitals are approved by the military ’s health department. The Ministry of Health ’s audit is extremely strict. However, many local research projects are approved in the province, even It is also approved by the prefecture-level health department. "An associate director of the Chinese Medical Doctors Association who asked not to be named said helplessly.

Wu Suwei of the Business Department of the Chinese Medical Doctors Association said at the cell therapy seminar: "Even the clinical research of mesenchymal stem cell transplantation has been halted, and the previous approval and filing are deemed to be legitimate. The Ministry of Health will issue" Stem Cell Research " And Applied Ethics Standards "will be released at the end of the year."

However, Zhang Mingliang's online search results suggest that every hospital promotes clinical treatment and attaches treatment cases to show the effect. Even the 261 hospital did not mention any clinical research words, but made a fuss about the treatment effect.

"There are also many stem cell studies in the United States, but there is a lot of leniency in and out of it. Phase I and II clinical trials are all about safety. Few can pass phase II clinical trials, not to mention large-scale treatment publicity to allow patients to pay for orders and make profits. "A scientist who participated in the cell therapy technology seminar said.

Although many industry experts believe that the effectiveness and safety of mesenchymal stem cells (except for hematopoietic stem cells) is difficult to draw conclusions, this has not stopped the large-scale commercialization of stem cell transplants that are still in the research stage, and even attracted many foreign patients. Come.

In 2007, the reporter saw a 10-year-old girl Linda, a Hungarian cerebral palsy patient, who came to China to receive a "neural stem cell transplant" in a hospital engaged in stem cell therapy in Zhejiang.

After hearing about the "Neural Stem Cell Transplantation" treatment carried out in China, Linda's family paid $ 20,000 in treatment fees and waited for the miracle to appear.

There were more than 20 patients from Hungary, Romania, the United States, Thailand, and the United Kingdom who lived with Linda in the "Cell Therapy and Rehabilitation Center" on the 20th floor of this hospital.

The company that provides stem cells to this hospital in Zhejiang is Shenzhen Beike Biology, a leader in the industry and the first commercial model of stem cells in China.

Xiao Nan commented: Medical institutions are the guarantee of our lives. If we put immature treatments on the stage for money, then we are not responsible for our lives. High medical expenses are the reason for this phenomenon, and patients choose stem cell therapy because they believe in medical standards. But in the end, it was revealed that the treatment process was not yet mature. Was it too irresponsible for the patient, because money blinded his eyes?

(Xie Yinan / Editor)

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