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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02855073
• Other study ID #: CBMG-ReJoinTM-CL-1.0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: Cellular Biomedicine Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years old, KOA couse = 10 years

• Kellgren-Lawrence ?-?

• 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

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• ReJoinTM
adipose derived mesenchymal progeinitor cells

Drug:
• Sodium Hyaluronate
Sodium Hyaluronate Injection

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC scores	WOMAC scoring will be performed 48 weeks after the first injection	48 weeks
Secondary	VAS scores	VAS scoring will be performed 8 weeks?24 weeks?36 weeks and 48 weeks after the first injection	0 day?8 weeks?24 weeks?36 weeks and 48 weeks
Secondary	SF-36 scores	SF-36 scoring will be performed 8 weeks?24 weeks?36 weeks and 48 weeks after the first injection	0 day?8 weeks?24 weeks? 36 weeks and 48 weeks
Secondary	Outbridge scoring	Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy	1 day and 24 weeks
Secondary	CRP	Serum CRP levels will be tested 8 weeks?24 weeks?36 weeks and 48 weeks after the first injection	0 day?8 weeks?24 weeks? 36 weeks and 48 weeks
Secondary	Cartilage defect size	Cartilage defect size will be measured at 24 weeks after the first injection	0 day and 24 weeks
Secondary	Cartilage volume	Cartilage volume will be measured at 24 weeks after first injection	0 day and 24 weeks