A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells (AlloJoin®) Therapy for Knee Osteoarthritis.

Wuxi Cellular Biopharmaceutical Group Ltd.2 sites in 1 country520 target enrollmentFebruary 28, 2025

ConditionsKnee Osteoarthritis

InterventionsMesenchymal Stem Cells Sodium Hyaluronate Injection

DrugsMesenchymal Stem Cells Sodium Hyaluronate Injection

Overview

Phase: Phase 3
Intervention: Mesenchymal Stem Cells
Conditions: Knee Osteoarthritis
Sponsor: Wuxi Cellular Biopharmaceutical Group Ltd.
Enrollment: 520
Locations: 2
Primary Endpoint: WOMAC score
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy

Registry

clinicaltrials.gov

Start Date

February 28, 2025

End Date

December 1, 2028

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wuxi Cellular Biopharmaceutical Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who understand and voluntarily sign the consent form before this study；
•According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed；Course of knee osteoarthritis was more than 6 months;
•Age: 40-75, males and females；
•The subjects' WOMAC score was 24-72
•The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III;
•Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches.

Exclusion Criteria

•The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on).
•The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells.
•The subject considered obese.
•Laboratory test (any item meets): neutrophil absolute number \< 1.0 × 10\^9 / L, platelet count \< 50 × 10\^9 / L, serum albumin \< 30g / L, serum creatinine \> upper limit of 1.2 times normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase \> upper limit of 2 times of normal value range.
•The subject has diseases or symptoms may affect VAS, WOMAC and so on.
•The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers.
•The subject has an history malignant tumour.
•The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis.
•The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial.
•According to the researchers, the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.

Arms & Interventions

Mesenchymal stem cells

Intervention: Mesenchymal Stem Cells

Sodium hyaluronate

Intervention: Sodium Hyaluronate Injection

Outcomes

Primary Outcomes

WOMAC score

Time Frame: 48 weeks

The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 48 weeks after the first injection

MRI quantitative analysis of articular cartilage

Time Frame: 24 weeks

Secondary Outcomes

MRI quantitative analysis of articular cartilage （volume change percentage）(12、48、104 weeks)
MRI quantitative analysis of articular cartilage (volume change)(12、24、 48 and 104 weeks)
VAS Score(4、12、24、36、48、60、72、84、104 weeks)
SF-36(4、12、24、36、48、60、72、84、104 weeks)
Whole-Organ Magnetic Resonance Imaging Score(12、24、48 and 104 weeks)
mJSW(104 weeks)
Physical examination(Day 0、week 1、2、3、4、12、24、36、48、60、72、84、104 weeks)
Adverse Events and Serious Adverse Events(Day 0 to 104 weeks)
WOMAC Score(4、12、24、36、60、72、84 and 104 weeks)