China puts stem-cell clinical trial regulation in play with draft for comment

Chinese health authorities have proposed some new regulations for conducting stem-cell clinical trials in the country, one requiring that a 30-year archive of the clinical records of stem-cell donors and patients be maintained.

Another provision in a proposal put out for public comment would require that patients receiving stem-cell transplants continue to be observed after the trials are over to ensure the long-term safety and effectiveness of the trial research, according to a report by the Xinhua state news agency.

Stem-cell researchers also would be required to halt a trial immediately after adverse reactions are observed and trial participants would have to be informed before the trial of the goals and risks of the treatment.

Another rule would require all trial participants to have insurance.

- here's the story from Xinhua