Xintela starts its first-in-human study (Phase I/IIa) with XSTEM® for the treatment of knee osteoarthritis in Australia. XSTEM, which consists of allogeneic (donated) integrin alpha10beta1-selected mesenchymal stem cells, is developed and manufactured by Xintela.
Patients with moderate knee osteoarthritis (grade II-III) will receive a single injection of XSTEM into the knee joint. Three different doses will be assessed in up to 54 patients and each patient will be followed for 18 months. The primary goal is to show that XSTEM is safe, but also to look for preliminary efficacy signals, such as reduced cartilage degradation, regeneration of damaged cartilage and improved joint function. Initial safety data is expected before the end of 2022 and early efficacy data during 2023.
“We are very excited to start treating osteoarthritis patients with our promising stem cell product XSTEM. We have received approval for the clinical study in Australia and are now ready to start recruiting patients. Our earlier preclinical studies have shown that XSTEM has a regenerative effect and therefore has the potential to be a DMOAD (Disease Modifying Osteoarthritis Drug) and a breakthrough treatment for osteoarthritis”, says Xintela’s CEO Evy Lundgren-Åkerlund.
