Treatment of acute respiratory distress syndrome (ARDS) using mesenchymal stem cells

Purpose and goal

The aims of the project were to validate the commercial, regulatory and intellectual property requirements for the development of a cell-based therapy for ARDS. In essence, the goals are met, but funding for the proposed clinical trial and the further development of the project is not yet secured.

Expected results and effects

The project resulted in the conclusion that the prerequisite regulatory pathway and intellectual property aspects to implement a cell-based therapy for ARDS exist. However, it has proved difficult to raise sufficient finances in Sweden for the development of an advanced cell-based therapy, partly because of limited access to venture capital and partly because the cell therapy field is to some extent associated with sub-optimal business conditions for clinical development and commercialization.

Planned approach and implementation

The first stage of the project was focused on studying the competitive and IP landscape, and identifying regulatory requirements and compile the IP portfolio. In a second phase, the orphan drug status was analyzed in detail, combined with a strengthening of the IP protection and strategy. In the final stage a business plan was compiled to enable more proactive business development, together with an identification and assessment of potential partners. Regulatory documentation was also prepared. Increased focus on international business development might have been important.