NCT07337863

A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate in Patients With Knee Osteoarthritis

A Randomized, Double-Blind, Multicenter, Phase II/III Clinical Study Comparing Umbilical Cord-Derived Mesenchymal Stem Cell Secretome Versus Sodium Hyaluronate on Clinical Outcomes, Pain, and Function in Patients With Kellgren-Lawrence Grade 2-3 Knee Osteoarthritis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universitas Sriwijaya · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.

Detailed description

This multicenter, randomized, double-blind Phase II/III clinical study aims to compare the efficacy and safety of intra-articular UC-MSC-derived secretome with sodium hyaluronate in patients with Kellgren-Lawrence grade 2-3 knee osteoarthritis. Eligible participants will be randomly allocated to one of two treatment arms. Clinical outcomes will be evaluated using validated pain and functional assessment tools at predefined time points. Safety assessments will include monitoring of adverse events throughout the study period. The results of this study are expected to provide evidence regarding the potential role of UC-MSC-derived secretome as an alternative therapeutic option for knee osteoarthritis.

Conditions

• Knee Osteoarthritis (Knee OA)

Interventions

Type	Name	Description
BIOLOGICAL	UC-MSC-Derived Secretome	Umbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol.
DRUG	Sodium Hyaluronate (Hyalein)	Sodium hyaluronate administered via intra-articular injection as an active comparator.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-16
• Completion: 2027-06-17
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Indonesia