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

NCT07337863 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: UCMSC-OA-Phase II/IIIPML-BFA-04-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Knee Osteoarthritis; UC-MSC Secretome; Randomized Controlled Trial; Sodium Hyaluronate; Intra-articular Injection

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in WOMAC Pain Subscale Score

  Change from baseline in knee pain assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale.

  Baseline to Week 24

Secondary Outcomes (1)

• Change From Baseline in WOMAC Total Score

  Baseline to Week 12

Study Arms (2)

UC-MSC-Derived Secretome

EXPERIMENTAL

Participants receive intra-articular injection of UC-MSC-derived secretome

Drug: Sodium Hyaluronate (Hyalein)

Sodium Hyaluronate

ACTIVE COMPARATOR

Participants receive intra-articular injection of sodium hyaluronate

Biological: UC-MSC-Derived Secretome

Interventions

UC-MSC-Derived Secretome BIOLOGICAL

Umbilical cord-derived mesenchymal stem cell secretome administered via intra-articular injection according to the study protocol.

Sodium Hyaluronate

Sodium Hyaluronate (Hyalein) DRUG

Sodium hyaluronate administered via intra-articular injection as an active comparator.

Also known as: Sodium Hyaluronate

UC-MSC-Derived Secretome

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females in the age range 40-70 years
• Radiographic evidence of grade 2 to 3 osteoarthritis (OA) based on Kellgren and Lawrence radiographic criteria.
• Body mass index between 18 - 30 kg/m2
• Female participants of childbearing age who agreed to use accepted methods of contraception during the course of the study.
• Ability to provide written informed consent and willing to participate the study

You may not qualify if:

• Participants who, based on physical examination and clinical history (anamnesis), are in the active or acute phase of cardiac, pulmonary, hematological, hepatic, renal, systemic autoimmune, immunodeficiency, or coagulation disorders that may interfere with the administration of the study drug (Secretome or Sodium Hyaluronate) will be excluded,
• Diagnosed with a meniscal rupture based on clinical history (anamnesis) and physical examination. If the anamnesis and physical examination show symptoms and signs of a meniscal rupture, further evaluation will be performed using ultrasound (USG),
• Participants with significant axial deviation, defined by valgus or varus deformity observed during physical examination, will be excluded,
• Participants with other pathological lesions on knee X-rays from the screening examination will also be excluded,
• History of any form of secondary arthritis in the knee due to trauma,
• History of surgery or major trauma to the knee joint
• Has knee effusion,
• Has any other inflammatory disorder of the knee joint
• Diagnosed with active malignancy.
• History of stem cell or secretome therapy.
• Intra-articular injection of corticosteroid and/or prior treatment with Sodium Hyaluronate and/or platelet rich plasma (PRP) in past 3 months.
• Use of NSAIDs and/or chondroprotective supplements, such as glucosamine and chondroitin sulfate, within 7 days before the trial, whether used orally, topically, or via injection,
• Undergoing immunosuppressive therapy, or anticoagulant therapy, or corticosteroid therapy.
• For women of child-bearing potential: positive pregnancy test or lactating (females who were planning pregnancy within the next year were excluded).
• Enrolled in any other clinical trials within the past four weeks.

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• PT Bifarma Adiluhung: collaborator

Study Sites (1)

RSUP Dr. Mohammad Hoesin Palembang

Palembang, South Sumatera, Indonesia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Radiyati Umi Partan, MD, PhD

  Universitas Sriwijaya

  STUDY CHAIR

Central Study Contacts

Rudi Erwin Kurniawan, MD, MH

CONTACT

+6282166114111; dr.rudierwin@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded to treatment allocation. UC-MSC-derived secretome and sodium hyaluronate will be prepared and administered in a similar manner to ensure blinding is maintained during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this parallel assignment study, participants will be randomized to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate.

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): June 17, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for up to 5 years.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study steering committee. Data will be shared under a data use agreement to ensure participant confidentiality and appropriate use of the data.

Locations

ID (1)