Closed Researched Projects

Central Innovation Program of the Federal Ministry of Economics and Technology

Funding reference: EP 121049


Current situation

In pharmaceutical research, there is a need for cell cultures of the three tissue types: endoderm, ectoderm and mesoderm. They should be derived from a single non-immortalized and non-tumorigenic cell line and are used as physiological models for pharmacological and toxicological tests.

TICEBA GmbH has profound knowledge in and holds various patents for isolating and cultivating pluripotent stem cells from human skin. As part of an R&D project, the conditions required for differentiation of pluripotent mesenchymal stem cells taken from the skin into the endoderm, ectoderm and mesoderm of the cotyledon were established and validated. As a result, a tool for testing pharmacological drugs or substances is now available.


Objective

To develop a cell differentiation assay (endodermal, ectodermal and mesodermal) based on pluripotent mesenchymal stem cells for use as a physiological model for pharmacological and toxicological testing of potential drugs.


Procedure

Procedure In addition to defining and validating the various biological constituents of ABCB5+ cells under GMP conditions, mycoplasma and endotoxin components could also be determined and validated.


Conclusion

Through the Central Innovation Program, TICEBA GmbH was able to create a cell differentiation tool for the pharmaceutical industry.


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News
Article about our study with limbal stem cells

On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELL in patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.

Clinical Trial - EB

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.

Clinical Trial - LSCD

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.

Safety

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

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