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.


partners
0

Countries
0

Funding
0.1
Million Euros from the EU

Duration
0
Years
Start
0
till the end of 2019

Objectives


LSFM4LIFE develops tools and technologies for the advanced cell therapy of type 1 diabetes

Production

Production


LSFM4LIFE produces long-term renewing, human pancreatic organoids (hPO) for T1D therapy and characterizes their genetic stability and in vivo safety.

Expansion

Expansion


LSFM4LIFE identifies the optimal expansion and differentiation conditions of hPO by employing high-throughput screening.

Standardization

Standardization


LSFM4LIFE standardizes the manufacture of hPO under xenogen-free and well-defined biochemical conditions, by employing new biomimetic scaffolds.

Regulatory-compliance

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“.

Partners