Technical Results

First, the German legal environment was identified and analyzed in depth. Key regulations from the Arzneimittelgesetz (AMG), Transplantationsgesetz (TGG), Genehmigungsgesetz (GenFG), Stammzellgesetz (StammZellG), and Embryonenschutzgesetz (ESG) were systematically reviewed. The analysis revealed specific licensing requirements for clinical trials, quality control standards for cell products, and patient consent provisions. Findings are slated for publication in the forthcoming chapter “Clinical Translation of hiPS‑cells in Germany” in the stakeholder handbook.

Second, the Austrian legal framework was mapped using the Arzneimittelgesetz (AMG), Gewebe- und Zellstoffgesetz (GZSG), Genehmigungsgesetz (GenFG), and Reproduktionsmedizinisches Gesetz (RMG). The study identified gaps in the current legislation, particularly regarding the definition of “cell therapy” and the approval pathway for hiPS‑cell‑derived products. These results will appear in the upcoming chapter “Clinical Translation of hiPS‑cells in Austria.”

Third, a comparative legal analysis highlighted both commonalities and divergences. Both countries require a clinical trial authorization, but Austria’s GZSG imposes stricter donor consent clauses, whereas Germany’s AMG mandates a more detailed risk assessment for cell‑based therapies. The comparative study will be published in the chapter “A Comparative Analysis of hiPS‑cell Clinical Translation in Germany and Austria.”

Fourth, the project produced a set of interdisciplinary recommendations—collectively termed the “Guidelines for Stakeholders.” These guidelines provide actionable advice for researchers, clinicians, and policymakers, including procedural checklists for trial approval, ethical considerations for patient recruitment, and suggestions for harmonizing regulatory submissions across the EU. The guidelines will be released in the stakeholder handbook and translated into English to broaden accessibility.

Finally, the project culminated in the creation of a stakeholder handbook that integrates scientific, entrepreneurial, patient‑oriented, ethical, and legal perspectives on hiPS‑cell application. The handbook, to be published by Springer, will include an overview chapter on the current state of hiPS‑cell clinical use, authored by the project team.

Collaboration

The initiative was a joint effort between the German Stem Cell Research Center, the University of Vienna, and several industry partners specializing in cell therapy manufacturing. Regular project meetings were held at the consortium’s website, and travel to national and international conferences facilitated knowledge exchange. Funding was provided under the project code FKZ: 01GP1602A, covering literature acquisition, meeting expenses, and conference travel.

• German Stem Cell Research Center – legal analysis and drafting of German regulatory review.
• University of Vienna – analysis of Austrian statutes and comparative legal assessment.
• Industry partners – contribution of practical insights on regulatory submissions and manufacturing compliance.
• Consortium stakeholders – participation in guideline development and stakeholder handbook editing.