Bifogade filer
Xintela completes dosing of XSTEM first dose level in knee osteoarthritis clinical study
Kurs & Likviditet
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
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®. All patients at the lowest dose level have now been dosed. 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 an 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. Initial safety data are expected before the end of this year and early efficacy results in 2023.
“The first 8 patients with knee osteoarthritis have now been injected with XSTEM. Each patient will be evaluated for 1 month for safety before we start dosing patients at the next dose level. We are pleased that our Phase I/IIa study is progressing well and are looking forward to the first safety readouts”, says Xintela's CEO Evy Lundgren-Åkerlund.