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
    0.1million
    From the EU
    Project 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 the 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 human pancreas organoids for the T1D therapy to the application GMP-level organoids ready for the implementation of the clinical phases

    TRL* 4

    Demonstration of effectivity and safety of the human pancreas organoids are demonstrated 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 type of 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 Organizations (EARTO) policy paper “The TRL Scale as a R & I Policy Tool – EARTO Recommendations“.

    Partners