UCSF investigators have developed a cGMP-compliant method to efficiently produce alloantigen-reactive regulatory T cells (arTregs) ex vivo for selective immune suppression. The method utilizes isolated patient regulatory T cells (Tregs) that are stimulated by and expanded in the presence of allogeneic B cells. The arTregs may be used to prevent or treat rejection of transplanted cells and organs, and to prevent or treat graft-versus-host disease (GvHD). The method is highly robust, and is one of the first cGMP-compliant approaches to efficiently expanding arTregs.
The method has been used to produce arTregs under GMP for several phase 1 trials of kidney and liver transplantation, and the therapy is well tolerated. A phase 2 study in liver transplantation will be initiated in 2020.
|United States Of America||Published Application||20180036345||02/08/2018||2011-138|