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The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients
In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.
The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy) |
|
| No treatment | No Intervention | No treatment (after high tibial osteotomy) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml | Biological | biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI scan | MRI perform to measure cartilage defect size change from baseline up to 27 weeks | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| MRI scan | MRI perform to measure cartilage defect size change from baseline up to 15 weeks | 15, 27 weeks, 18, 24 months |
| WOMAC score | Change in WOMAC Total score from baseline up to 15, 27 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KANGIL KIM, M.D., Ph.D | KyungHee University Gangdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KyungHee University Gangdong Hospital | Seoul | 134-727 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35674255 | Derived | Kim JH, Kim KI, Yoon WK, Song SJ, Jin W. Intra-articular Injection of Mesenchymal Stem Cells After High Tibial Osteotomy in Osteoarthritic Knee: Two-Year Follow-up of Randomized Control Trial. Stem Cells Transl Med. 2022 Jun 22;11(6):572-585. doi: 10.1093/stcltm/szac023. |
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|
| 15, 27 weeks, 18, 24 months |
| WOMAC sub-scale | Change in WOMAC sub-scale from baseline up to 15, 27 weeks | 15, 27 weeks, 18, 24 months |
| Kellgren & Lawrence grade | Change in Kellgren & Lawrence grade from baseline up to 15, 27 weeks | 15, 27 weeks, 18, 24 months |
| EQ5D | Change in the score of EQ-5D from baseline up to 15, 27 weeks | 15, 27 weeks, 18, 24 months |
| ROM | change from baseline in knee flexion Range of Motion(ROM) at 15,27 weeks by physical examination | 15, 27 weeks, 18, 24 months |
| KOOS (Knee Injury & Osteoarthritis Outcome Score) | Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS) | 15, 27 weeks, 18, 24 months |
| PGIC(Patient Global Impression of Change) | The percentage of subjects who were evaluated as improved at 15 weeks and 27 weeks in the patient global impression of change | 15, 27 weeks, 18, 24 months |
| PSQI(Pittsburgh Sleep Quality Index) | Change in PSQI from baseline up to 15, 27 weeks | 15, 27 weeks, 18, 24 months |
| Biomarkers | Change from baseline in Biomarkers up to 15, 27 weeks | 15, 27 weeks, 18, 24 months |
| Incidence of adverse reactions and characteristics associated with investigational product | 15, 27 weeks, 18, 24 months |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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