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Background: Currently no treatments are available that truly impact the progressive nature of knee osteoarthritis (OA), and following failure of conservative approaches, many patients ultimately require Total Knee Replacement (TKR) surgery. This major surgical intervention is associated with a long and complicated rehabilitation period, and a substantial rate of later complications requiring further interventions. However, the growing understanding of the role of inflammatory mediators in the propagation of OA and articular cartilage and joint damage may prove to be a new therapeutic approach. Allocetra TM is an innovative allogeneic cellular therapy that modulates the function of activated macrophages in an attempt to reset inflammatory balance, by harnessing the naturally occurring property of apoptotic cells to induce an immuno-modulated pro-homeostatic state. In order to address the need for new therapies which may mitigate or delay the deterioration to TKR surgery, Allocetra TM treatment for knee OA was evaluated.
Objectives: The clinical trial aimed to evaluate the safety and preliminary efficacy of intra-articular (IA) injection of Allocetra TM in patients with end-stage knee OA.
Methods: This is a single center open-label study which evaluated the safety and initial efficacy of intra-articular administration of Allocetra TM in patients with end-stage knee OA. Patients were adults with pain and functional disability due to advanced knee OA which was indicated for knee replacement surgery. Patients were treated with an IA injection of Allocetra TM to the knee and followed for safety reactions following injection. Responses to treatment were assessed by patient self-reporting of pain (scale 0-10) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires.
Results: A total of 18 patients were enrolled in the study. Patients had advanced OA, with a radiographic classification of Kelgren-Lawrence grade 4 (13 patients) or 3-4 (5 patients), and an average pain of 7 at baseline. Patients were treated with an IA injection of Allocetra TM to the target knee on Day 0, and went on to report pain and WOMAC pain, stiffness and function at defined timepoints up to 2 years. No serious adverse events were reported. Patients reported transient events of discomfort/pain or swelling in the knee following injection, which were conservatively managed. To date, all patients completed at least 3 months of follow-up, demonstrating an average 30% reduction of reported pain, compared to baseline. This improvement was maintained at 6 months, where 43% of patients still reported a reduction of at least 30% in their knee pain, compared to baseline. These results were also supported by the WOMAC scores reported at 3 months, reflecting a consistent improvement in both pain and function. Moreover, to date, only 2/18 patients proceeded to undergo knee replacement surgery. In order to further assess the therapeutic potential of Allocetra TM in these patients, a second IA injection of Allocetra was offered to participants and – follow-up is ongoing.
Conclusion: The study results indicate a favorable safety profile following Allocetra TM IA injection in this population of patients with end-stage knee OA indicated for knee replacement surgery. Surprisingly, despite the advanced articular damage many of the patients reported a meaningful improvement in their knee pain, allowing them to preserve their functionality without resorting to extensive knee surgery. This initial study is followed by an ongoing double blind, randomized, multi-center study to evaluate the safety and efficacy of intra-articular administration of Allocetra TM compared to placebo in patients with symptomatic knee OA.
REFERENCES: NIL.
Acknowledgements: NIL.
Disclosure of Interests: None declared.
© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (