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

Shanghai AbelZeta Ltd.6 sites in 1 country488 target enrollmentOctober 2023

ConditionsKnee Osteoarthritis

InterventionsMesenchymal progenitor cells Sodium Hyaluronate Injection

DrugsSodium Hyaluronate Injection

Overview

Phase: Phase 3
Intervention: Mesenchymal progenitor cells
Conditions: Knee Osteoarthritis
Sponsor: Shanghai AbelZeta Ltd.
Enrollment: 488
Locations: 6
Primary Endpoint: WOMAC score
Status: Not yet recruiting
Last Updated: 2 years 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 Progenitor Cells Therapy

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

October 2023

End Date

December 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai AbelZeta 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；
•Age: 40-75, males and females；
•The course of knee osteoarthritis was more than 6 months;
•The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC score at least 48 hours after discontinuation of all painkillers);
•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 has a BMI of over
•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 progenitor cells

Mesenchymal progenitor cells group

Intervention: Mesenchymal progenitor cells

Sodium hyaluronate

Sodium hyaluronate injection group

Intervention: Sodium Hyaluronate Injection

Outcomes

Primary Outcomes

WOMAC score

Time Frame: 24 weeks

The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection