Source: China’s NMPA Approves Country’s First MSC-Based Cell Therapy, Ruibosheng, BioInformant, 13 Jan 2025. Summary written by Future Health GCC.
What happened
On 2 January 2025, China’s National Medical Products Administration gave conditional approval to amimestrocel injection, sold under the name Ruibosheng. It is the first therapy in China made from mesenchymal stem cells taken from human umbilical cord tissue.
What it treats
It is approved for steroid-refractory acute graft-versus-host disease (GVHD). GVHD can happen after a patient receives blood stem cells from a donor, when the donor’s immune cells attack the patient’s body. When it does not respond to steroids, the usual first treatment, it is serious and can be fatal.
Mesenchymal stem cells are studied for their ability to calm the immune system and reduce inflammation, which is why they are being used for this condition.
How far along it is
This is a conditional approval, which means the company must continue to provide evidence. According to BioInformant, it brings the number of mesenchymal stem cell products approved for sale anywhere in the world to 12. Only one of them is approved in the United States.
What it means for families
It is a milestone for umbilical cord tissue as a source of therapeutic cells: a regulator has now approved a treatment made from them. The approval is for one specific condition in China, and the treatment is made from donated cord tissue.
Read the original article on BioInformant →
This is a summary of published research, written by Future Health GCC. It is not medical advice. Speak to your doctor about any treatment.
Photo: NCATS / NIH, via Wikimedia Commons (public domain).