Xintela has started last dose level of XSTEM in knee osteoarthritis clinical study
Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis, being conducted in Australia, is testing three different dose levels of the stem cell product XSTEM®. The Safety Review Committee for the clinical study assessed the treatment of the eight patients on the second dose level with XSTEM at the one-month follow-up, concluded the dose is safe, and approved the continuation to dosing of patients at the third and last dose level. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela.
Patients with moderate knee osteoarthritis (grade II-III) receive one injection of XSTEM into the knee joint. Three different dose levels are being evaluated in 24 patients with the option to add additional patients up to 54 patients. Each patient will be followed for 18 months with an efficacy reading every six months. The primary goal is to show that XSTEM is safe, and also to investigate preliminary efficacy signals, such as reduced breakdown of joint cartilage, regeneration of damaged cartilage, and improved joint function. Safety data from all dose levels and early efficacy results are expected in 2023.
"We are very pleased to see that our study with XSTEM in the treatment of knee osteoarthritis is progressing well and that the last dose level has started. We look forward to establishing the safety for all dose levels and to start evaluating the effect of the treatment”, says Camilla Wennersten, Director Clinical Development of Xintela.