Xintela starts next 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 3 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 lowest XSTEM dose level at the one-month follow-up, concluded the dose is safe, and approved the continuation to dosing of patients at the second 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 up to 54 patients and each patient will be followed for 18 months with an efficacy reading every 6 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.
"Completion of the safety evaluation for the lowest dose of XSTEM in the treatment of knee osteoarthritis and the decision to proceed with the inclusion of patients at the next dose level is an important milestone. To accelerate patient recruitment, we are now adding another clinical site to the study. 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.