Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReJoinTM Group | Experimental | Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15. |
|
| Sodium Hyaluronate Group | Active Comparator | subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReJoinTM | Biological | adipose derived mesenchymal progeinitor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC scores | WOMAC scoring will be performed 48 weeks after the first injection | 48 weeks |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| You Wang | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai ninth people's hospital | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32043426 | Derived | Qiao Z, Tang J, Yue B, Wang J, Zhang J, Xuan L, Dai C, Li S, Li M, Xu C, Dai K, Wang Y. Human adipose-derived mesenchymal progenitor cells plus microfracture and hyaluronic acid for cartilage repair: a Phase IIa trial. Regen Med. 2020 Jan;15(1):1193-1214. doi: 10.2217/rme-2019-0068. Epub 2020 Feb 11. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sodium Hyaluronate | Drug | Sodium Hyaluronate 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 |
| D012216 |
| Rheumatic Diseases |