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This study aims to compare the efficacy of Umbilical Cord Mesenchymal Stem Cell and secretome between arthroscopy and without arthroscopy intervention in OA patients. This study has 4 arms namely Arthroscopy + Booster, Arthroscopy + Pre-conditioning, Non-Arthroscopy + Booster, Non-Arthroscopy + Pre-conditioning.
The study subjects each group amounted to 5 patients suffering from osteoarthritis. Patients are evaluated before, and 1,3,6 months after injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopy + Booster | Experimental | After arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. |
|
| Arthroscopy + Pre-Conditioning | Experimental | After arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. |
|
| Non Arthroscopy + Booster | Experimental | Without arthroscopy intervention, patient will be given 10 million UC-MSCs and 2 cc Secretome twice with 2 weeks interval via intra-articular injection. |
|
| Non Arthroscopy + Pre-Conditioning | Experimental | Without arthroscopy intervention, patient will be given 2 cc Secretome, 10 million UC-MSCs, and 2 cc Secretome with 2 weeks interval via intra-articular injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome | Biological | After Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 1 month after injection |
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 3 month after injection |
| Visual Analog Scale (VAS) | To asses pain score, score 1(good)-10(worst) | 6 month after injection |
| Western Ontario and McMaster Universities Osteoarthritis Index | To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. | 1 month after injection |
| Western Ontario and McMaster Universities Osteoarthritis Index | To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. | 3 month after injection |
| Western Ontario and McMaster Universities Osteoarthritis Index | To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. | 6 month after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Asessment | COMP, MMP-13, IL-6 | 2 weeks after injection |
| Laboratory Asessment | COMP, MMP-13, IL-6 | 1 month after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gatot Soebroto Hospital | Jakarta Pusat | DKI Jakarta | 10410 | Indonesia |
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|
| Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome | Biological | After Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. |
|
| Non Arthroscopy with Mesenchymal Stem Cells + Secretome + Secretome | Biological | Without Arthroscopy intervention, patient recieve 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, two weeks afterward, patient receive 2 cc Secretome, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. |
|
|
| Non Arthroscopy with Secretome + Mesenchymal Stem Cells + Secretome | Biological | Without Arthroscopy intervention, patient recieve 2 cc Secretome, two weeks afterward patient receive 10 million Allogeneic Umbilical Cord Mesenchymal Stem Cells in 2 cc NaCl, and four weeks later, patient receive another 2 cc Secretome. All intervention will be done via Intra-articular. |
|
| Laboratory Asessment | COMP, MMP-13, IL-6 | 3 months after injection |
| Magnetic Resonance Imaging (MRI) T2 mapping | MRI T2 mapping is used for cartilage evaluation | 6 month after injection |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| D000089282 | Secretome |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
| D055442 | Metabolome |
| D008660 | Metabolism |
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