Defect of Articular Cartilage, Knee Osteoarthritis
Conditions
Keywords
adipose-derived mesenchymal progenitor cells, Artz
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.
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.
Interventions
BIOLOGICALReJoinTM
adipose derived mesenchymal progeinitor cells
DRUGSodium Hyaluronate
Sodium Hyaluronate Injection
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai AbelZeta Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC scores | 48 weeks | WOMAC scoring will be performed 48 weeks after the first injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed