Knee Osteoarthritis
Conditions
Keywords
Amniotic fluid mesenchymal stem cells, Knee Osteoarthritis
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALallogenic amniotic fluid mesenchymal stem cell
Intra-articular AFCC injection will be given for single knee for each patient in single dose, 20 million of AFCC in each dose
Sponsors
Siriraj Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 60 to 80 years 2. The Visual Analog Scale (VAS) score of the subject's knee joint was greater than 4 3. Knee pain needs at least 15 days of experience. 4. The Kellgren Lawrence grade of the subject's knee joint was II/III as per the axial position X-ray. 5. Subjects who understand and voluntarily sign the consent.
Exclusion criteria
1. The subject has secondary osteoarthritis (such as other joint arthritis, major trauma on the study joint in the previous 3 months, axial deviation angle beyond 15 degrees of the bones of the knee joint) 2. The subject has other known rheumatic or inflammatory diseases (such as rheumatoid arthritis and inflammatory arthritis). 3. The subject has other conditions that cause knee joint pain (such as cancer, joint tumor) 4. The subject who awaiting knee surgery 5. The subject has an underlying disease that affects treatment during 1 year (such as cancer, liver disease, severe kidney disease, SLE) 6. The subject has a history of vertebral fracture or leg bone fracture 7. The subject has a nervous system disorder that affects balance (such as stroke or Parkinson's disease) 8. The subject has an acute or chronic infectious disease 9. The subject who had evidence of knee surgery 10. The subject who has received intra-articular steroids or other substances within the last 6 months. 11. The subject who has received symptomatic slow-acting drugs for osteoarthritis (SYSADOA) within the last 4 months 12. The subject has a deformity of the knee joint. 13. The subject has any other pathological conditions 14. The subject has a communication problem 15. The subject has claustrophobia 16. The subject who had surgery to insert a cardiac pacemaker 17. The subject who had surgery to insert an aneurysm clip 18. The subject who had surgery to insert a cochlear implant 19. The subject has any internal metallic objects (such as metal plates, surgical clips, bullets)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The type of Adverse event (AE), numbers of AE and proportion of patients with AE. | Day 0 to 7, 14, 30, Month 2 to 12 | AE will be monitored and recorded by the investigator throughout the study. |
| Incidence of abnormal vital sign | Month -3, Day 0, Month 3, 6 and 12 | 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. |
| Incidence of abnormal laboratory test results | Day 0, Month 3, 6 and 12 | 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. |
| Incidence of abnormal ECG parameters | Day 0, Month 3, 6 and 12 | 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 |
| Incidence of abnormal physical examination | Month -3, Day 0, Month 3, 6 and 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Screening (Month -3), Day 0, Month 3, 6, and 12 | Assessment changes of knee complaints by using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire |
| Degree of cartilage change | Screening (Month -3), Day 0, Month 3, and Month 12 | Assessment change of joint narrowing space width using Radiography (X-ray) and Magnetic Resonance Imaging (MRI) |
| Pain score | Screening (Month -3), Day 0, Month 3, 6, and 12 | Change in pain in the affected knee joint in response to treatments using the Visual Analog Score (VAS) |
Countries
Thailand
Outcome results
None listed