Osteoarthritis
Conditions
Keywords
chondrocyte cells, osteoarthritis, gene therapy
Brief summary
The purpose of this study is to evaluate the efficacy and safety of intraarticular Invossa K Injection patients diagnosed with Kellgren & Lawrence grade 2 knee osteoarthritis.
Interventions
BIOLOGICALInvossa K Inj.
Invossa K Inj.
DRUGPlacebo
Placebo control
Sponsors
Kolon Life Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 19 and older 2. Patients with IKDC Subjective Knee Evaluation of ≤ 60 of the target knee. 3. Patients with a score of ≥ 40 on the 100 mm pain VAS of the target knee. 4. Patients with grade 2 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence 5. BMI should fall between 18.5 and 30 6. Patients who satisfies the clinical/radiational criteria by the American College of Rheumatology guidelines, and applies to one of the following. * Age \> 50 years old * Morning stiffness \< 30 minutes * Crepitus and Osteophytes 7. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms 8. Patients with persistent symptoms in spite of conservative therapy for more than 3 months : Improvement of 100 mm VAS are less than 10 mm after 3 months 9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history 10. Agreed to use an effective contraceptive method during the study period 11. Voluntarily agreed to participate in this study, and signed the informed consent form
Exclusion criteria
1. Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit (But, possible to include after 14 days of wash-out period) 2. Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit (But, possible to include after 14 days of wash-out period) 3. Patients with severe pain in other areas that could effect the diagnosis of the symptoms 4. Patients over Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence 5. History of surgery like arthroendoscopy within the past 6 months on the target knee 6. Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months 7. History of injection within the past 3 months on the target knee 8. Pregnant or breastfeeding female 9. With another joint disease apart from degenerative arthritis 10. Patients with hepatitis including carrier 11. Patients with HIV and an infectious disease which is clinically uncontrolled 12. Patients who have any of the following clinically significant diseases or have a medical history within 6 months : * Clinically significant heart diseases which are considered by the investigator * Uncontrolled hypertension : if the systolic blood pressure exceeds 160 mmHg or diastolic blood pressure exceeds 100 mmHg in a sitting position * Kidney disease * Liver disease * Endocrine disease * Uncontrolled diabetes mellitus : HbA1c ≥ 9% * Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease * Genetic diseases (hyperkinesia, collagen gene abnormality) 13. Medical history of past or current malignant tumor 14. Patients with a history of anaphylactic reactions 15. Patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide, mannitol, dextran 40 or bovine proteins 16. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study 17. Patients who administered the INVOSSA K inj. 18. Considered inappropriate by the investigator for participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IKDC (International knee documentation committee) Subjective Knee Evaluation | Week 0 and 52 | Changes in IKDC Subjective Knee Evaluation (score) |
| 100 mm VAS (Visual analogue scale) | Week 0 and 52 | Changes in 100 mm VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 100 mm VAS | Week 0, 26 and 39 | Changes in 100 mm VAS |
| OMERACT-OARSI (Outcome measures in rheumatology-Osteoarthritis research society international) response rate | Week 26, 39 and 52 | OMERACT-OARSI response rate after administration (%) |
| MRI scan | Week 0, and 52 | Changes in MRI scan |
| Joint Space Width | Week 0, and 52 | Changes in Joint Space Width (mm) |
| Biomarker (CTX-I) in blood | Week 0, 26, and 52 | Levels of CTX-I in blood (ng/ml) |
| WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index) score | Week 0, 26, 39 and 52 | Changes in WOMAC (score) |
| Rescue Medication (Dosage) | Week 0, 4, 12, 26, 39, and 52 | Dosage of Rescue Medication (mg) |
| Rescue Medication (Frequency) | Week 0, 4, 12, 26, 39, and 52 | Frequency of Rescue Medication (number) |
| Drop-out rate | Week 0, 4, 12, 26, 39, and 52 | Drop-out rate (%) |
| Reason of drop-out | Week 0, 4, 12, 26, 39, and 52 | Reason of drop-out is recorded in CRF (Case Report Form), when the patient is dropped-out according to drop-out criteria (e.g. Withdraw a consent, Patients who can not continuously participate in study due to adverse events, Impossible to follow-up of the patient. etc.). |
| Biomarker (CTX-II) in urine | Week 0, 26, and 52 | Levels of CTX-II in urine (ng/ml) |
| IKDC Subjective Knee Evaluation | Week 0, 26 and 39 | Changes in IKDC Subjective Knee Evaluation (score) |
Countries
South Korea
Outcome results
None listed