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

Shanghai AbelZeta Ltd.7 sites in 1 country106 target enrollmentMay 16, 2020

ConditionsKnee Osteoarthritis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Shanghai AbelZeta Ltd.
Enrollment: 106
Locations: 7
Primary Endpoint: WOMAC Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria 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 II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis. This is a multicenter, randomized, double-blinded, phase II clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different group after signing the ICF and screening tests. Each group was treated for two cycles. The patients were followed up to 48 weeks after the first treatment.

Registry

clinicaltrials.gov

Start Date

May 16, 2020

End Date

July 31, 2023

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 and less than 10 years;
•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 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.

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

Secondary Outcomes

VAS Score(4、8、12、24、36、48 weeks)
Changes of laboratory test indexes and vital signs(0d、1、3、4、8、12、24、25、27、28、36、48 weeks)
MRI quantitative analysis of articular cartilage(24 weeks,48 weeks)
WOMAC Score(4、8、12、36、48 weeks)
SF-36(4、8、12、24、36、48 weeks)
Adverse Events and Serious Adverse Events(0d、1、3、4、8、12、24、25、27、28、36、48 weeks)