Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects

Shanghai AbelZeta Ltd.28 enrolled

Overview

The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.

This is a randomized, single-blind,phase II clinical trial. At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks. In addition, external control will be added if necessary.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Defect of Articular Cartilage Knee Osteoarthritis

Interventions

ReJoinTMBIOLOGICAL

adipose derived mesenchymal progeinitor cells

Sodium HyaluronateDRUG

Sodium Hyaluronate Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-70 years old, KOA couse ≤ 10 years * Kellgren-Lawrence Ⅰ-Ⅲ * VAS core \>6， more than 4 months * Signed informed consent from the subject * cartilage defect 2-6cm2 Exclusion Criteria: * Pregnancy test positive. * Subject infected with hepatitis C, HIV or syphilis. * Subject enrolled in any other cell therapy studies within the past 30 days. * Subject deemed to be not suitable for the study by the investigator

Locations (1)

Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

WOMAC scores

WOMAC scoring will be performed 48 weeks after the first injection

Time frame: 48 weeks

Secondary Outcomes

VAS scores

VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection

Time frame: 0 day、8 weeks、24 weeks、36 weeks and 48 weeks

SF-36 scores

SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection

Time frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks

Outbridge scoring

Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy

Time frame: 1 day and 24 weeks

CRP

Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection

Time frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks

Cartilage defect size

Cartilage defect size will be measured at 24 weeks after the first injection

Time frame: 0 day and 24 weeks

Cartilage volume

Cartilage volume will be measured at 24 weeks after first injection

Time frame: 0 day and 24 weeks

Data from ClinicalTrials.gov

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