Stem cell treatments in China: what is approved and what is not
- Only a small number of stem cell therapies have been approved for clinical use in China, all through the Hainan Boao Lecheng pilot zone or the national drug regulator.
- Most stem cell treatments offered to foreign patients in China are either registered clinical research or unregistered procedures with unclear evidence.
- You can check whether a specific project is on the national registered clinical research list; if it is not, it is not approved.
What is actually approved
China's National Medical Products Administration (NMPA) has approved a limited number of cell therapy products, including CAR-T therapies for certain blood cancers. These are approved drugs with marketing authorization, not experimental procedures.
The Hainan Boao Lecheng International Medical Tourism Pilot Zone has a separate pathway that allows use of certain technologies not yet approved elsewhere in mainland China, under its own regulations. The Hainan Provincial Health Commission publishes a list of approved technologies; only items on this list may be offered to patients there.
What is not approved
The National Health Commission (NHC) requires all stem cell clinical research to be filed with the agency and conducted at approved hospitals with ethics review. Offering stem cell treatments outside this framework, or charging patients for unregistered procedures, is not permitted.
The US FDA has issued repeated warnings about unapproved stem cell treatments, including a 2019 safety communication and permanent injunctions against clinics. The International Society for Stem Cell Research (ISSCR) has published guidelines distinguishing approved therapies from unproven interventions.
How to check a specific program
- Ask the hospital for the NHC research filing number and the ethics approval document.
- Search the China Clinical Trial Registry (ChiCTR) or ClinicalTrials.gov for the study.
- For Lecheng: ask for the specific approval document from the Hainan Provincial Health Commission.
- If the provider cannot produce any of these, the treatment is not in an approved pathway.
Why we removed the prices
We previously listed prices for three stem cell procedures offered in the Lecheng pilot zone. After review, we determined that presenting these as comparable "treatment prices" alongside approved medical procedures could mislead patients about the evidence base. We have removed them from our price index and redirected this page to a risk advisory.
Sources
Information only. Not medical advice, diagnosis or a treatment recommendation. Talk to your doctor. In an emergency, call your local emergency number.