ARTCLINE Advances with 100 Patients Enrolled in Septic Shock Study

Artcline GmbH has reached a milestone in its ReActIF-ICE clinical study, with 100 out of 142 planned patients enrolled. This multicenter study, taking place in 20 intensive care centers in Germany, evaluates the ARTICE® therapy's effectiveness in treating septic shock by enhancing immune function. The study aims to complete recruitment by the end of 2025, with a market launch expected in the latter half of 2026.

The ARTICE® procedure involves using immune cells from healthy donors to regenerate patients' compromised immune systems. The study will assess safety, focusing on serious adverse events up to 28 days. Secondary goals include mortality rates and changes in organ failure assessment scores.

Regulatory approval has been secured for the ARTICE® components, setting the stage for its anticipated release and potentially significant impact on septic shock treatment outcomes. The initiative underscores an unmet need in severe sepsis therapy, a condition responsible for a substantial global mortality rate annually.