U.K. firm Sistemic reported its participation in an EU-funded collaborative project, Regener-AR, which aims to progress TiGenix’ Cx611 stem cell therapy for rheumatoid arthritis through early clinical trials. The TiGenix-led project is funded to the tune of €5.9 million through the European Seventh Framework Programme (FP7).
Cx611 utilizes stem cells extracted from adipose tissue (eASCs), and is undergoing Phase I/II testing in a clinical trial in Spain. Sistemic will bring its miRNA fingerprinting SistemQC™ stem cell characterization and QC tool-kit into the clinical development program, for process optimization and QC testing of the cell therapy product.
Sistemic is exploiting an miRNA profiling technology through a range of drug development and bioprocessing products. The SistemQC platform combines miRNA profiling with statistical and contextual analytics, for applications in monitoring product quality, benchmarking cell models, evaluating lot-to-lot variability, and assessing drift of cell lines over time. The firm has in addition exploited its miRNA fingerprinting technology to develop a range of products for use by the pharma industry in toxicity and drug response testing.
TiGenix is developing a range of allogeneic eASC-based stem cell products for treatment of complex perianal fistulas in Crohn disease, rheumatoid arthritis, osteoarthritis, and other autoimmune diseases. Cx611 was the first of these to move into clinical development. An autoimmune disease candidate, Cx621, has also been granted regulatory clearance by the Spanish authorities to start in initial clinical evaluation. Cx621 is designed to be delivered directly into the lymph nodes, delivered via a proprietary technique for direct administration.
TiGenix’ flagship cartilage regenerating product, ChondroCelect®, is an implantable suspension of ex vivo-expanded autologous cartilage cells. The product was granted approval in the EU in 2009 for the repair of single symptomatic cartilage defects of the femoral condyle of the knee. The firm claims ChondroCelect is the first cell-based product to complete development and achieve centralized EU registration as an approved Advanced Therapy Medicinal Product (ATMP).
TiGenix has also received approval in the EU for its ChondroMimetic product, a porous resorbable implant comprising collagen, glycosaminoglycan, and calciumphosphate, which has been developed to stimulate regenerative repair of joint surfaces and bony defects caused by trauma or disease.