Xintela’s stem cell product, XSTEM, has been assessed as safe at all dose levels 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 has now assessed all three dose levels safe at the planned three-month follow-up. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is being developed and manufactured by Xintela.
Patients with moderate knee osteoarthritis (grade II-III) have received one injection of XSTEM into the knee joint. Three different dose levels have so far been dosed in 24 patients (8 patients/dose level). The study enables an expansion of up to a total of 54 patients. Each patient is followed for 18 months with an efficacy reading every six months. The primary goal of the study is to show that XSTEM is safe. In addition, preliminary efficacy signals, such as reduced pain and improved joint function as well as reduced breakdown of joint cartilage and regeneration of damaged cartilage are being investigated.
“It is very gratifying and an important milestone that the safety of all three dose levels of XSTEM has now been established in the clinical study in osteoarthritis patients. We now look forward to continuing to evaluate the clinical efficacy of the treatment. When we have additional data from the three doses, we will decide on the possible expansion of the study”, says Camilla Wennersten, Director Clinical Development of Xintela.