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In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
Osteoarthritis (OA) is one of the most common forms of arthritis. It is a lasting condition in which the material that cushions the joints, called cartilage, breaks down. This causes the bones to rub against each other, causing inflammation, stiffness, pain and loss of joint movement. Currently, there are few effective treatments available for patients suffering from OA.
Mesenchymal stem cells (MSCs) are cells that have the ability to self-regenerate, which means they have the ability to make copies of themselves and to turn into other kinds of cells (e.g. cartilage cells). Stem cell science shows much promise for the future treatment of osteoarthritis, but much of the research is still in the early stages. In this study, researchers want to determine the safety of MSCs that a patient can tolerate without causing side effects. Moreover researchers will also be looking at the function of the knee over time, which may give them some insight on the usefulness of MSCs as a treatment option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placenta Derived Mesenchymal Stem Cell | Experimental | Placenta Derived Mesenchymal Stem Cell administered into the knee joint once |
|
| sodium hyaluronate | Active Comparator | Sodium hyaluronate administered into the knee joint once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placenta Derived Mesenchymal Stem Cell | Biological | 1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Number of participants with adverse events as measure of safety and tolerability | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| radiographic evidence | Number of participants with a change in cartilage thickness of knee OA using MRI | 1 Year |
| WOMAC assessment | Number of participants with a change in joint function from baseline WOMAC assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YU TANG, Dr. | Affiliated Hospital of Jiangsu University | Principal Investigator |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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A Randomized, Double Blind, Phase-II Study Assessing the Safety and Efficacy of Intraarticular Ex-vivo Cultured Adult Allogeneic Mesenchymal Stem Cells in Patients with Osteoarthritis of Knee
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Double blind
|
| Sodium Hyaluronate | Drug | Sodium hyaluronate administered into the knee joint once |
|
|
| 1 Year |
| VAS | Number of participants with a change in arthritis pain scores on the visual analogue scale | 1 Year |
| SF-36 | Number of participants with a change in SF-36 | 1 Year |