NCT02855073

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

A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Defect of Articular Cartilage
• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	ReJoinTM	adipose derived mesenchymal progeinitor cells
DRUG	Sodium Hyaluronate	Sodium Hyaluronate Injection

Timeline

• Start date: 2014-07-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-08-04
• Last updated: 2018-12-17

Locations

1 site across 1 country: China