Recruiting

IxCell hUC-MSC-O for Knee Osteoarthritis

What is being tested

Human umbilical cord mesenchymal stem cells

+ Placebo

Biological

Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

From 40 to 80 Years

+31 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 3

Interventional

Study Start: January 2024

See protocol details

Summary

Principal SponsorShanghai IxCell Biotechnology Co., LTD

Study ContactJie Zhao

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 5, 2024

Actual date on which the first participant was enrolled.

This study aims to assess the effectiveness and safety of a treatment called IxCell hUC-MSC-O for individuals with knee osteoarthritis, a condition causing pain and stiffness in the knee joint. The focus is on using mesenchymal stem cells (MSCs), which are special cells capable of transforming into different types of cells and can help repair damaged cartilage in the joint. MSCs have shown promise in previous research for their ability to reduce inflammation and promote healing, which makes this study particularly important for finding new ways to manage osteoarthritis, potentially improving joint function and quality of life for those affected. Participants in this study will receive an injection of the treatment directly into the knee joint. The study is designed to compare the effects of the actual treatment against a placebo, ensuring that any improvements can be attributed to IxCell hUC-MSC-O itself. Throughout the study, researchers will closely monitor participants to evaluate both the effectiveness of the treatment in relieving symptoms and any possible side effects. This approach helps ensure that the treatment is both safe and beneficial for managing the symptoms of knee osteoarthritis.

Official TitleA Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis

NCT06716281

Principal SponsorShanghai IxCell Biotechnology Co., LTD

Study ContactJie Zhao

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

398 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

7 inclusion criteria required to participate

Patients diagnosed with knee osteoarthritis according to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association;

Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal anti-inflammatory drugs, viscosupplementary therapy, etc.;

The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;

Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;

Show More Criteria

24 exclusion criteria prevent from participating

Patients diagnosed with secondary knee osteoarthritis;

Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis, symptomatic chondrocalcinosis, osteonecrosis, or active infections, lower limb arteriosclerosis obliterans, etc.);

Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;

Patients who have previously used stem cell therapy;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

IxCell hUC-MSC-O;2.5×10\^7 cells/1 mL, 1 mL/vial; 2ml

Group II

Placebo

Sodium Chloride Injection；1 mL/vial；2ml

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, ChinaOpen The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine in Google Maps

Recruiting

One Study Center