ACT2 Project

Description

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 UoB is 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 labaratory the only viable option. The OsCell Laboratory at The Robert Jones and Agnes Hunt Hospital (RJAH) has the unique requirements to deliver the project within the financial and time restrictions facing the project. Lot 1: Our decision to exclusively source the OsCell laboratory to manufacture the chondrocyte therapy is founded on several irrefutable factors. The OsCell Laboratory is the only GMP facility within the UK who currently manufacture a GMP compliant chondrocyte therapy for clinic use. It is the most experienced laboratory in the UK for the manufacture of chondrocytes, with a proven track record of chondrocyte manufacture since 1997. OsCell is the only GMP laboratory in the UK with the necessary experience of process development and the validation of new therapies for cartilage repair, as well as producing cells for use in a clinical trial of a cell therapy for cartilage repair. RJAH and the OsCell Laboratory, together with Keele University, instigated and delivered the ACTIVE trial (ISRCTN48911177), which remains the largest clinical trial investigating a chondrocyte cell therapy in the world. In addition, the RJAH and OsCell Laboratory has just completed the ASCOT trial (ISRCTN98997175), a randomised controlled trial of autologous chondrocyte implantation vs. two mesenchymal stem cell (MSC) therapies, 1 of which was combined with chondrocytes. No other facility in the UK possesses the capability to furnish us with the complete suite of resources, knowledge, experience and support necessary to uphold the exceptional standards of research and innovation we strive to maintain. The funding requirements and the current project status require the manufacturer to be in a position to commence manufacture within 2 months. The location of the OsCell laboratory is unique in that it is on the same site as the Keele University researchers involved in the study. This provides the researchers with the opportunity to closely interact with the facility to enable rapid knowledge transfer and ensure, as best as possible, that the future timelines of the project are met. It is anticipated that the manufacture protocols of the new therapy can be easily embedded within the facility and minimise the training requirements, hence facilitating a relatively early adoption. In addition, the close proximity will allow for optimised training and practice, negating the need for additional ethical and administrative approvals. The use of any other facility would result in significant delays, particularly regarding training and administration, which would threaten the project timelines. The nature of the OsCell Laboratory facility is also unique in that only 1 research project at a time is accepted by the facility, guaranteeing the project will receive the necessary priority that the current imposed timelines necessitate. The Qualified Person (QP) involved in the project for the last 14 months would remain in place, ensuring continuity. No other facility can provide a QP with prior knowledge of the project and experience of currently supervising the release of manufactured chondrocytes for clinical use in a UK facility.