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| ID | Type | Description | Link |
|---|---|---|---|
| CTM_LESÃO ARTICULAR-461/2010 | Other Grant/Funding Number | Fundação Araucária |
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| Name | Class |
|---|---|
| Pontifícia Universidade Católica do Paraná | OTHER |
| Consultório Médico Dr. Alcy Vilas Boas Jr., Paraná, Brasil | UNKNOWN |
| Hospital Marcelino Champagnat, Paraná, Brasil | UNKNOWN |
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This is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.
Osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. However, these treatments rarely modify the course of the disease.Recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. We designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stem cells | Experimental | Bone marrow aspiration, Autologous bone marrow-derived mesenchymal stem cells |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone marrow aspiration | Procedure | Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC (Western Ontario and McMaster Universities)score | 3 months, 6 months, 9 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in cartilage thickness at 6 months by MRI | 6 months | |
| Knee pain relief (WOMAC and Lequesne scores) | 3 months, 6 months, 12 months | |
| Change from baseline in progression of osteoarthritis at 12 months by plain radiograph (X-ray) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulo Brofman, PhD | Pontifícia Universidade Católica do Paraná | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Tecnologia Celular, Pontifícia Universidade Católica do Paraná | Curitiba | Paraná | 80215-901 | Brazil |
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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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| Fundação Araucária |
| OTHER |
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| 12 months |