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

Phase 2

• Conditions: Defect of Articular Cartilage; Knee Osteoarthritis
• Interventions: Biological: ReJoinTM; Drug: Sodium Hyaluronate

• Registration Number: NCT02855073
• Lead Sponsor: Shanghai AbelZeta Ltd.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ReJoinTM Group	ReJoinTM	Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
Sodium Hyaluronate Group	Sodium Hyaluronate	subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.

Primary Outcome Measures

Name	Time	Method
WOMAC scores	48 weeks	WOMAC scoring will be performed 48 weeks after the first injection

Secondary Outcome Measures

Name	Time	Method
VAS scores	0 day、8 weeks、24 weeks、36 weeks and 48 weeks	VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
SF-36 scores	0 day、8 weeks、24 weeks、 36 weeks and 48 weeks	SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Outbridge scoring	1 day and 24 weeks	Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
CRP	0 day、8 weeks、24 weeks、 36 weeks and 48 weeks	Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Cartilage defect size	0 day and 24 weeks	Cartilage defect size will be measured at 24 weeks after the first injection
Cartilage volume	0 day and 24 weeks	Cartilage volume will be measured at 24 weeks after first injection

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China