Xintela completes XSTEM dosing at third and final dose level in knee osteoarthritis clinical study
All patients on the third and final dose level have now been dosed in Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis in Australia where three different dose levels of the stem cell product XSTEM® are being tested. The primary goal of the study is to show that XSTEM is safe but also to investigate preliminary efficacy signals.
XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and produced 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 a total of 24 patients with the possibility to increase the number up to 54 patients. The first two dose levels have been considered safe at the one month follow-up and all patients have now been dosed at the third and final dose level.
Each patient will be followed for 18 months with efficacy readings every six months. The primary goal is to show that XSTEM is safe, but also investigate preliminary efficacy signals, such as reduced pain, reduced degradation of articular cartilage, regeneration of damaged cartilage and improved joint function. Xintela has previously reported that patients treated with the lowest dose of XSTEM, experience reduced pain and improved function of the knee after six months.
"All 24 osteoarthritis patients have now been treated with one dose of XSTEM. It is encouraging that the study is progressing so well and that patients experience a positive effect of the treatment at the lowest dose level. We look forward to the continued evaluation of all dose levels and to take the next step in the clinical development," says Camilla Wennersten, Director Clinical Development.