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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
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Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells low-dose group | Experimental | Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks. |
|
| Mesenchymal stem cells mid-dose group | Experimental | Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks. |
|
| Mesenchymal stem cells high-dose group | Experimental | Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells low-dose group | Biological | Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recording of Adverse Events and Serious Adverse Events | 12 weeks | |
| Electrocardiogram | 9 weeks | |
| Vital signs | 9 weeks | |
| Physical examination | 9 weeks | |
| WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) | 24 months | |
| Laboratory tests | Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 | 24 months | |
| NRS-11 | 24 months | |
| The volume of articular cartilage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chunde Bao, M.D. & Ph.D. | Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29417902 | Derived | Song Y, Du H, Dai C, Zhang L, Li S, Hunter DJ, Lu L, Bao C. Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections. Regen Med. 2018 Apr;13(3):295-307. doi: 10.2217/rme-2017-0152. Epub 2018 Feb 8. |
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|
| Mesenchymal stem cells mid-dose group | Biological | Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use |
|
|
| Mesenchymal stem cells high-dose group | Biological | Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use |
|
|
| 24 months |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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