Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
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|ClinicalTrials.gov Identifier: NCT02855073|
Recruitment Status : Active, not recruiting
First Posted : August 4, 2016
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Defect of Articular Cartilage Knee Osteoarthritis||Biological: ReJoinTM Drug: Sodium Hyaluronate||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
adipose derived mesenchymal progeinitor cells
Other Name: adipose derived mesenchymal progenitor cells
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 Name: Artz
- WOMAC scores [ Time Frame: 48 weeks ]WOMAC scoring will be performed 48 weeks after the first injection
- VAS scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 day and 24 weeks ]Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
- CRP [ Time Frame: 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 [ Time Frame: 0 day and 24 weeks ]Cartilage defect size will be measured at 24 weeks after the first injection
- Cartilage volume [ Time Frame: 0 day and 24 weeks ]Cartilage volume will be measured at 24 weeks after first injection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855073
|Shanghai ninth people's hospital|
|Shanghai, Shanghai, China, 200011|
|Study Director:||You Wang||Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University|