Efficacy and Safety of ELIXCYTE Intra-articular Injection in Subject With Knee Osteoarthritis
Status:
Not yet recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
This is a Phase III, single-blinded (subject-blinded), placebo-controlled, multicenter study
to investigate the efficacy and safety of a new study intervention, ELIXCYTE, compared to
placebo (normal saline) in subjects with knee osteoarthritis. The primary hypothesis of the
study is to demonstrate that ELIXCYTE is superior to placebo (saline) in improving knee pain
on the target knee from baseline.
During the study, each participant will receive either ELIXCYTE (study intervention) or
placebo (normal saline) intra-articular injection once on the target knee after eligibility
criteria check. The target knee will be assessed by X-ray, MRI and subject self-evaluation
knee questionnaires (WOMAC, KSS and KOOS) in the following visits. Other safety assessments,
including lab test, physical examination, vital sign, medical/medication history and adverse
events will also be collected throughout the study.