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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis, Defect of Articular Cartilage

Intervention / Treatment
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* Biological: ReJoinTM
* Drug: Sodium Hyaluronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReJoinTM Group<br>Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15. | Biological: ReJoinTM<br>* adipose derived mesenchymal progeinitor cells<br>* Other names: adipose derived mesenchymal progenitor cells;|
| Active Comparator: Sodium Hyaluronate Group<br>subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22. | Drug: Sodium Hyaluronate<br>* Sodium Hyaluronate Injection<br>* Other names: Artz;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC scores | WOMAC scoring will be performed 48 weeks after the first injection | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Outbridge scoring | Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy | 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 | 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 | 0 day and 24 weeks | 
| Cartilage volume | Cartilage volume will be measured at 24 weeks after first injection | 0 day and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose-derived mesenchymal progenitor cells, Artz