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Regulation reins in stem cell therapy for safety and efficacy

Shan Juan
Updated: Aug 22,2015 10:46 AM     China Daily

China is aiming to control the “wildly” growing practice of stem cell therapy, issuing on Aug 21 its first regulation covering the largely controversial medical procedure in terms of safety and efficacy.

All treatments involving stem cells will be considered experimental except for hemopoietic stem cell therapy treating a variety of blood diseases, including leukemia, said the regulation by the National Health and Family Planning Commission.

“Only eligible hospitals can work with stem cells in clinical trials for research and there must not be fees or advertising,” said Zhang Linming, a senior official in the commission’s Science and Technology Department.

The regulation stipulates that only top State-owned hospitals, widely known as 3A, can become eligible after passing special evaluations by health authorities.

A list of the authorized hospitals will soon be made public and channels for public reporting of violations set up, he added.

Currently, many Chinese hospitals, mostly small ones, offer stem cell treatment for a range of conditions and illnesses, including spinal-cord injuries, epilepsy, cerebral palsy, cancers and autism. They even attract patients from abroad, and they charge a lot.

Zhang said the commission had taken note of the situation and “would count on the new regulation as a legal basis for cleaning up the sector.”

Huang Xiaojun, head of the Peking University Institute of Hematology and a member of the commission’s stem cell therapy experts’ panel, said stem cell therapy is not ready for wide clinical use given unconfirmed safety risks and efficacy.

He said potential risks include infections, deformity, irreversible organ injury and death. “Recipients must be informed of all the possible risks and give written consent to start any clinical trials for stem cell therapies.”

In addition, practitioners are required to register all proceedings, problems and outcomes with health authorities.

Huang urged the public to be highly cautious about “experimental” treatment, and those who decide to go ahead with it should choose qualified practitioners.

Previous estimates in 2011 put the number of stem cell treatment hospitals in China in the hundreds.