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

Cellular Biomedicine Group

Status and phase: Unknown; Phase 2

Conditions: Defect of Articular Cartilage; Knee Osteoarthritis

Treatments: Biological: ReJoinTM; Drug: Sodium Hyaluronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02855073

CBMG-ReJoinTM-CL-1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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28 participants in 2 patient groups

ReJoinTM Group

Experimental group

Description:

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

Treatment:

Biological: ReJoinTM

Sodium Hyaluronate Group

Active Comparator group

Description:

subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.

Treatment:

Drug: Sodium Hyaluronate