Xintela has released interim data from its ongoing clinical study evaluating its stem cell product, XSTEM, in patients with knee osteoarthritis. XSTEM is an allogeneic adipose stem cell therapy, consisting of integrin α10β1-selected mesenchymal stem cells.
At 18 months post-treatment, the company reports demonstrated safety and positive efficacy, including statistically significant and clinically meaningful improvements in knee pain and knee function.
Additionally, the data suggest beneficial effects on bone structure and indicate a potential to slow cartilage breakdown, supporting XSTEM’s possible disease-modifying properties in treating osteoarthritis. Among the three dose levels tested, the highest dose showed the most pronounced therapeutic effect.
About the trial:
The ongoing Phase I/IIa clinical trial is a first-in-human study evaluating XSTEM for knee osteoarthritis. It includes three dose levels (4, 8, and 16 million stem cells), with eight patients enrolled per dose group, totaling 24 patients aged 41-75 years.
Participants with symptomatic moderate knee osteoarthritis (Kellgren-Lawrence [KL] grade II-III) receive a single injection of XSTEM into the knee joint. The primary objective is to assess the safety and tolerability of XSTEM, with secondary exploratory endpoints including efficacy parameters—pain reduction, improvements in joint function, and changes in cartilage and bone structure—evaluated every six months.
Xintela performed the interim analysis based on data collected up to 18 months after XSTEM treatment. Here are the key findings:
– All doses appear safe and well tolerated, no adverse events reported.
– The highest dose group (16 million stem cells) showed greater improvements in knee pain, function, and structural changes in bone and cartilage compared to the lower dose groups.
– Patients receiving the highest dose experienced statistically significant, clinically meaningful, and sustained improvements in knee pain and function assessments (assessed by VAS [Visual Analog Scale] and KOOS [Knee Injury and Osteoarthritis Outcome Score]) up to 18 months post-treatment compared to pre-treatment baseline.
– In the highest dose group, knee pain was reduced by 63% (VAS), and all patients showed clinically meaningful improvements in activities of daily living (KOOS-ADL) at 18 months post-treatment compared to baseline.
– The highest dose group also showed improvements in subchondral bone structure (indicating reversal of osteoarthritis-related bone changes) and suggested a trend toward preventing cartilage breakdown, effects not observed in the lower dose groups.
The study will conclude following a 24-month follow-up period for patients receiving the highest dose level of XSTEM. Final results are expected to be reported in September 2025. Patients in the lowest and middle dose groups have completed their participation in the study, concluding at the 18-month follow-up.
