May 10, 2019
The LITTMUS team announced the first enrollment and first liver transplantation, which occurred at Massachusetts General Hospital on May 1st 2019. The LITTMUS study will test a new approach to achieve transplant tolerance using the liver transplant recipient’s own T regulatory cells (Tregs).
The LITTMUS Consortium consists of researchers from MGH and UCSF who first met at the June 2016 ATC meeting in Boston. Since then, study development has progressed on two separate but aligned and harmonized protocols in parallel. One protocol is for 9 MGH participants who will receive an arTreg-CSB product manufactured at the Connell & O’Reilly Families’ Cell Manipulation Core Facility (CMCF) at the Dana Farber Cancer Institute (DFCI); the other protocol is for 9 UCSF participants who will receive an arTreg product manufactured at the Human Islet and Cellular Transplantation Facility (HICTF) and GMP Facility at UCSF.
These two trials are open-label, non-randomized clinical trials exploring cellular therapy to facilitate anti-rejection medication withdrawal in liver transplant recipients. Individuals who are wait-listed liver transplant candidates will be approached for interest in the study and enrolled prior to transplant. Once participants undergo transplant, they will go through a series of eligibility evaluations to prepare them for the Treg infusion. Following the Treg administration, eligible participants will undergo a supervised, step-wise withdrawal of anti-rejection medications over time. The goal of transplant tolerance will be achieved if participants are free of signs of liver rejection for 52 weeks after the discontinuation of all anti-rejection medications.
Congratulations to the LITTMUS team on this important milestone!
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