An international group of stem-cell researchers is urging China to cancel draft regulations that would permit some hospitals to sell therapies developed from patients’ own cells, without approval from the nation’s drug regulator.
The International Society for Stem Cell Research (ISSCR) sent a statement outlining its concerns to Jiao Hong, director of China’s National Medical Products Administration in Beijing, on 20 May. The society, which is based in Skokie, Illinois, represents more than 4,000 scientists, clinicians and ethicists around the world.
“We are deeply concerned that China’s newly proposed regulations will provide incentives for hospitals to market unsafe and ineffective interventions directly to consumers. This has the potential to harm the people of China, undermine public health and discredit the international standing of the Chinese regenerative medicine community,” warns the statement, which was signed by society president Doug Melton.
Under the proposal, which was released in March, select hospitals will be allowed to sell cell therapies — which are made from human cells, often from the immune system, to treat diseases such as cancer — without first testing the treatments in large numbers of people. The law is expected to come into effect over the next few months, although it is unclear whether further changes will be made.
In many countries, cell therapies must go through rigorous clinical trials to show that they are safe and effective before drug regulators approve them for sale.
The letter states that the “limited safety and efficacy testing” for cell therapies proposed in the draft policy is not adequate, and does not meet international standards.
The ISSCR urged China’s government to rescind the draft regulations and only allow the use of stem-cell-based therapies in well-regulated clinical trials or products approved by the National Medical Products Administration after demonstrating they are safe and effective in trials.
Clinics offering unproven stem-cell therapies have proliferated around the world. There have been numerous documented cases of acute and chronic complications and other adverse events, including death, following such treatment.
The ISSCR says that regulators in the United States, Australia and Canada are strengthening rules to reduce the marketing of unproven cell therapies, and it advises China to do the same.