Activated donor immune cells may prevent severe complication after allogeneic stem cell transplantation
Researchers have successfully conducted the first clinical trial using activated regulatory T cells (ATregs, Actileucel)—derived from white blood cells of healthy blood donors. This novel cell therapy aims to prevent graft-versus-host disease (GvHD) following an allogeneic stem cell transplant. The Phase I/II study has yielded extremely encouraging results: ATregs can be produced within 24 hours…
A groundbreaking clinical trial has successfully demonstrated the potential of activated regulatory T cells, or ATregs, to prevent graft-versus-host disease (GvHD) in patients who undergo allogeneic stem cell transplantation. Researchers from ActiTrexx in Mainz developed a novel cell therapy that uses Tregs harvested from healthy, unrelated blood donors and activates them with a patented stimulant.
This process significantly enhances Tregs' tolerance-promoting effect and reduces the number of cells needed to prevent GvHD. A Phase I/II study involving 10 patients at sites in Mainz, Dresden, Münster, and Dortmund showed that ATregs can be produced within 24 hours and administered immediately afterward without serious side effects.
The trial results indicate that ATregs can successfully engraft and do not cause severe graft-versus-host disease or transplant-related mortality, demonstrating both safety and feasibility. This innovative approach eliminates the need for complex cell expansion from genetically compatible donors, making ATreg a more universally applicable and practical treatment option. Future studies will be necessary to confirm the therapy's superiority over standard prophylaxis.
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