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 LFM4LIFE 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.

Partners