A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Shanghai AbelZeta Ltd.1 site in 1 country22 target enrollmentDecember 2015

ConditionsOsteoarthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Shanghai AbelZeta Ltd.
Enrollment: 22
Locations: 1
Primary Endpoint: WOMAC Score
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

Detailed Description

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis. This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

March 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai AbelZeta Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Object has an allergic history or is of an allergic constitution.
•Subjects who understand and sign the consent form for this study.
•Age: 18-70, males and females.
•Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)\> 4 months.
•Course of Knee osteoarthritis:6 months to 10 years;
•The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).

Exclusion Criteria

•The subject has an allergic history of medicine or food。.
•The subject'BMI is over
•The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung， endocrine system.
•The subject has an history malignant tumour.
•The subject has complications or diseases of: systemic or rheumatoid arthritis, 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 in the 3 months prior to this trial.
•The subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
•The subject has coagulation disorders.
•The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.
•The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.