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Phase II/III Randomized Trial of UC-MSC Secretome vs Sodium Hyaluronate in Knee Osteoarthritis

NCT07337863 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Knee Osteoarthritis (Knee OA)

Interventions

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.

Sponsors & Collaborators

  • PT Bifarma Adiluhung

    collaborator INDUSTRY

  • Universitas Sriwijaya

    lead OTHER

Principal Investigators

  • Radiyati Umi Partan, MD, PhD · Universitas Sriwijaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2026-09-16
Completion
2027-12-24

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337863 on ClinicalTrials.gov