Strategy and regulatory pathway for StemCART - A stem cell derived cartilage repair product

Purpose and goal

Cline develops a cell-based implant for effective regeneration of cartilage tissue. This product aim to overcome technical challenges resulting in a safe, high-quality, and native-like cartilage available to large numbers of patients. This project support the transition from preclinical to clinical phase. The focus will be on the regulatory area, creating a gap analysis and setting the strategy for the regulatory pathway to be approved for the First-in-human clinical trial. With the help of an external partner the knowledge will be implemented to increase the internal competence.

Expected results and effects

To maximize the impact of the project, it has been built to ensure the successful transfer of skills and knowledge obtained. After creating the gap analysis and the development strategy, a briefing book for submission and discussion with EU national regulators is planned, with subsequent regulatory meeting minutes, follow-up and an updated development plan. One of the main deliverables is to deliver a strategy for future regulatory work to be conducted by the Cline team beyond this project and a gap analysis allowing Cline to be aware of its areas of missing competence and fill those.

Planned approach and implementation

The work will be carried out by the hired experts closely alongside Cline, specific activities such as workshops and education across the team have been planned. The regulatory consultant will support Cline in establishing an integrated CMC, non-clinical and initial clinical development strategy which will then be validated. This work will be carried out mainly through processes of consultation, desktop research, report writing, and workshop activities.