ACT2 (Allogeneic Chondrocyte Therapy - A phase 2a) Study

Descriptions

University of Birmingham (UoB) is the sponsor of ACT2 (Allogeneic Chondrocyte Therapy - A phase 2a study), an MRC funded project (MR/V027670/1). The study commenced in 2021 with the aim to develop and manufacture an allogeneic chondroprogenitor cell therapy from fresh osteochondral allografts in order to treat cartilage lesions in a single surgery. The study requires a manufacturing facility that can work with the research team to develop and validate the manufacturing process of the cell therapy product to a standard that can gain MHRA approval and thus enable the commencement of a Phase 2a human trial. Due to unforeseen circumstances, previously contracted GMP manufacturers are no longer able to manufacture the cell therapy product and, thus an alternative manufacturing facility is required expeditiously.

The UoB team must operate within the restrictions placed upon them by the funder and the current project plan. In addition to this, the administrative burden as a consequence of BREXIT makes the use of a UK laboratory the only viable option. The Newcastle Advanced Therapies Facility has the unique requirements to deliver the project within the financial and time restrictions facing the project.