Are Stem Cell Treatments Regulated in China?

China seeks to regulate thriving stem cell industry: At least 10,000 people from around the world travel to China every year seeking experimental stem cell therapies for various ailments, many debilitating and untreatable.

These medical tourists are part of a thriving unregulated trade in unproven treatments that make use of stem cell products that have not been approved by local or international health authorities and are often or at best on clinical trial.

Because stem cells have the ability to become any type of cell in the human body, researchers across the globe are studying them to see if they can cure disease. Stem cell therapies treat disease or injury by introducing into damaged tissues new cells that nudge the damaged ones to regenerate.

Because of the promise such therapies hold for many stubbornly untreatable diseases, the unregulated industry is thriving and very lucrative around the world, and in China. Desperate patients are often willing to pay tens of thousands of dollars in a last ditch attempt to restore sight or other functions lost to disease.

According to industry analysts, around 100 hospital and medical facilities in large Chinese cities offer stem cell therapies for many diseases—particularly diabetes, spinal cord injury, cerebral palsy, brain injury, stroke, cancer and Alzheimer’s disease.

The treatments that are backed by little or no scientific evidence and are, at best, considered experimental, the International Medical Travel Journal reports.

“Some of these involve large general hospitals where patients pay thousands—or even tens of thousands—of dollars for treatments that are advertised online, which attract both Chinese patients and those from overseas,” the IMTJ article says.

But, the article claims, that many “patients have come away with little or no improvement and a number have died.”

Military hospitals
Many military hospitals — most likely because of their facilities, equipment, trained scientists and access to medical technologies — are part of this thriving trade, Qiu Renzong, a leading bioethicist with the Chinese Academy of Social Sciences, told China Daily.

While many stem cell therapies are being offered in Chinese medical institutions, only adult stem cells sourced from bone marrow and umbilical cords for treating blood cancer have been proven safe and effective, Renzong said.

The World Health Organization also says more scientific data in terms of safety and efficacy is needed before stem cell treatment can be applied to humans.

At the General Hospital of Chinese People’s Armed Police Forces, around 80 patients, including 10 expats, are currently undergoing stem cell treatment, a nurse with surname Qiao who works with that hospital’s stem cell transplantation department told China Daily. She said her department has treated more than 4,000 patients from 15 countries since 2003.

Year-long regulatory campaign
Seeking to regulate the industry to ensure the safety of stem cell products and therapies, China’s health ministry announced on Jan. 11 that will halt new applications for clinical trials of stem-cell products until July 1.

Speaking in a webcast by China.com.cn, Deng Haihua, Ministry of Health representative, said the year-long campaign to regulate the industry’s development will be overseen by his ministry and the State Food and Drug Administration. The statement is in posted the government website.

Deng said that this means that:

  • Medical institutions that have approved stem cell studies underway shouldn’t alter them or charge volunteers for tests.
  • Trials that haven’t been approved should be stopped.

“All medical research and clinical practices of stem cell therapy without approval from the ministry and the State Food and Drug Administration will be put to an end after the overhaul,” Deng said.

According to the minister, China authorities have never approved any stem cell therapy on the mainland, largely because providers of stem cell products and therapies have not been able to address concerns over ethics and efficacy adequately.

But in reality, says Yang Jian, CEO of the Shanghai Medical Tourism Products and Promotion Platform, the demand for the treatments has driven practice for a long time, and the industry has been growing rapidly.

And whether the Chinese government can enforce the ban is questionable, as many hospitals making money from stem cell treatment are affiliated with government organizations—such as the army and the domestic police forces. These institutions are more powerful than both government departments tasked to enforce the stem cell ban.

In 2009, both regulators were unable to enforce an order compelling hospitals and clinics offering advanced and experimental medical technology to obtain approval first for these technologies or face closure.

If it’s any indicator, right now, Yang says, some hospitals exploit regulatory loopholes to carry out controversial therapies that have not been checked for safety and efficacy.

Asked how the overhaul would affect their business, nurse Qiao said that because her hospital was affiliated with the armed police, it would not be subject to regulation by the health ministry.

China’s stem cell development

Since 2007, China adopted a four-way approach to build its stem-cell industry. The approach included permissive policies on stem cells, recruiting Chinese expatriates into local research, and giving the industry an annual funding of about US $320 million, said Ipshita Chakraborty, a Calcutta-based industry analyst for Frost & Sullivan.

Currently, the potential of Chinese stem-cell research is high, said Chakraborty, who tracks technology and investment opportunities in the stem cell space for the Mountain View, California-based consulting company. “There’s a body of research that is more than enough to commercialize,” she said.

A more stringent regulatory system will allow Chinese institutions to sell products overseas, the analyst told Bloomberg Businessweek.

“One industry shortcoming for a long time was a lack of a globally compliant regulatory system,” she said. “The regulatory system is the most important, so if (China) focus (es) on that, that’s good news for them: they’re putting focus on their investment in the right direction.”

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