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Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life.
Ten patients, aged between 60 and 80 of both genders, who were diagnosed with knee osteoarthritis at Kellgren and Lawrence (KL) score 2-3 were selected based on strict inclusion and exclusion criteria. Each patient was treated with a single intra-articular injection of 20 million cells of amniotic fluid mesenchymal stem cells in AFCC type into an OA knee. After the treatment, they were monitored through clinical assessment and laboratory investigation, including blood chemistry test and Magnetic Resonance Imaging (MRI) of the treated knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFCC injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogenic amniotic fluid mesenchymal stem cell | Biological | Intra-articular AFCC injection will be given for single knee for each patient in single dose, 20 million of AFCC in each dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of abnormal physical examination | The following examinations will be conducted: general appearance, respiratory, abdomen, nervous system, muscoskeletal system and etc. In case of abnormal conditions, they shall be recorded as an adverse event. | Month -3, Day 0, Month 3, 6 and 12 |
| Incidence of abnormal vital sign | The following assessment will be conducted: heart rate, blood pressure and temperature. In case of abnormal results, they shall be record as an adverse event. | Month -3, Day 0, Month 3, 6 and 12 |
| Incidence of abnormal laboratory test results | The following lab tests will be conducted: serum chemistry, haematology, liver function test. In case of abnormal results, they shall be recorded as an adverse event. | Day 0, Month 3, 6 and 12 |
| Incidence of abnormal ECG parameters | The following assessments will be conducted: 12 lead ECG recordings with long Lead II, and two-dimensional echocardiography (2D ECHO; if needed). In case of abnormal conditions, they shall be recorded as an adverse event | Day 0, Month 3, 6 and 12 |
| The type of Adverse event (AE), numbers of AE and proportion of patients with AE. | AE will be monitored and recorded by the investigator throughout the study. | Day 0 to 7, 14, 30, Month 2 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS) | Screening (Month -3), Day 0, Month 3, 6, and 12 |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatsanee Phermthai, PhD. | Siriraj Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Ten elderly patients from both gender diagnosed with knee osteoarthritis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with amniotic fluid mesenchymal stem cells developed for chondrogenic treatment. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.
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Assessment changes of knee complaints by using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
| Screening (Month -3), Day 0, Month 3, 6, and 12 |
| Degree of cartilage change | Assessment change of joint narrowing space width using Radiography (X-ray) and Magnetic Resonance Imaging (MRI) | Screening (Month -3), Day 0, Month 3, and Month 12 |
| D012216 |
| Rheumatic Diseases |