Osteoarthritis, Knee
Conditions
Brief summary
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K&L Grade III/IV.
Detailed description
Study Design: open-label, single-center, dose-escalation study
Interventions
BIOLOGICALANT-301
Administration on Day 1
Sponsors
Anterogen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form 2. Patients aged 19 to 70 years old. 3. Patients diagnosed with K&L grade III/IV knee osteoarthritis 4. Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale
Exclusion criteria
1. Patients with joint diseases other than osteoarthritis 2. Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening 3. Patients who received intra-articular injections within 6 months prior to the screening 4. Patients who have received systemic steroid therapy within 3 months prior to the screening 5. Patients who have received immunosuppressive agents within 3 months prior to the screening 6. Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening 7. Patients who are unwilling to use contraception during the clinical trial period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | Week 2, 4, 8, 12, 24 and Month 12 | Number of Adverse events and Laboratory Abnormalities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain improvement according to VAS scale measurements | Baseine, Week 4, 8, 12, 24 and Month 12 | The VAS scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain. |
| IKDC score | Baseline, Week 4, 8, 12, 24 and 12 months | IKDC subjective knee evaluation form scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). |
| WOMAC questionnaire score | Baseline, Week 4, 8, 12, 24 and 12 months | Difference in WOMAC questionnaire scores between baseline and each visit |
Countries
South Korea
Outcome results
None listed