Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ReJoinTM Group 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
adipose derived mesenchymal progeinitor cells
Other Names:
|
| Active Comparator: Sodium Hyaluronate Group subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22. |
Drug: Sodium Hyaluronate
Sodium Hyaluronate Injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- WOMAC scores [48 weeks]
WOMAC scoring will be performed 48 weeks after the first injection
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai ninth people's hospital | Shanghai | Shanghai | China | 200011 |
Sponsors and Collaborators
- Cellular Biomedicine Group Ltd.
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
- Study Director: You Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CBMG-ReJoinTM-CL-1.0