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A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate in Patients With Knee Osteoarthritis
Sponsor: Universitas Sriwijaya
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-01-01
Completion Date
2027-06-17
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
UC-MSC-Derived Secretome
Umbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol.
Sodium Hyaluronate (Hyalein)
Sodium hyaluronate administered via intra-articular injection as an active comparator.
Locations (1)
RSUP Dr. Mohammad Hoesin Palembang
Palembang, South Sumatera, Indonesia