Production and characterization of endocrine cells derived from human pancreas organoids for cell-based therapy of
type 1 diabetes
LSFM4LIFE is a project.
The aim of LSFM4LIFE is the isolation and therapeutic-scale manufacture of human pancreas organoids for the cellular therapy of type 1 diabetes (T1D). Pancreas organoids, which are grown from adult stem cells, are a small in vitro version of pancreas. The production of pancreas organoids from adult stem cells has been established in 2013.
Objectives
LSFM4LIFE develops tools and technologies for the advanced cell therapy of type 1 diabetes
Production
LSFM4LIFE produces long-term renewing, human pancreatic organoids (hPO) for T1D therapy and characterizes their genetic stability and in vivo safety.
Expansion
LSFM4LIFE identifies the optimal expansion and differentiation conditions of hPO by employing high-throughput screening.
Standardization
LSFM4LIFE standardizes the manufacture of hPO under xenogen-free and well-defined biochemical conditions, by employing new biomimetic scaffolds.
Regulatory Compliance
LSFM4LIFE achieves regulatory-compliant GMP production of hPO for pre-clinical studies and phase I clinical trials.
Outcomes
LSFM4LIFE intends to bridge the “valley of death” from the idea of using human pancreas organoids for T1D therapy to the application of GMP-level organoids for the implementation of the clinical phases
TRL* 4
Demonstration of effectivity and safety of the human pancreas organoids in a relevant laboratory animal (mouse)
TRL* 4/5
GMP batch of hPO fulfilling the requirements for phase 1 clinical trials
TRL* 6
hPO in multiwell format for the research in type 1 diabetes
*TRL: The Technology Readiness Levels (TRL) scale is a measurement system used to assess the maturity level of a technology. There are nine levels from TRL 1, the lowest, to TRL 9, the highest.
More information on the European Association for Research and Technology Organisations (EARTO) policy paper “The TRL Scale as a R & I Policy Tool – EARTO Recommendations“.
