A Open, Single-center, Phase 1 Trial to Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Medipost Co Ltd.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change of total score in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) compared to baseline at 6 months after treatment
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1.
A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).
Detailed Description
All subjects in each dose-group will visit 1 month\* (visit 5, 1 month±5 days) after administration of investigational product to evaluate dose limit toxicity (DLT) and determine whether to drop or proceed to next dose level. Total 5 visit (1week, 1 month, 2 months, 3 months, 6 months) until 6 months after administration of investigational product is planned to assess safety through vial sign, laboratory tests, and exploratory efficacy of IP will be assessed through Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS) and International Knee Documentation Committee (IKDC) subjective knee evaluation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female over 19 years of age
- •Subject with knee osteoarthritis (OA) and were diagnosed K\&L grade 2 or 3 in radioactive examination at time of screening
- •Subject with more than 40mm joint pain on the 100-mm VAS, at the time of screening
- •Subject who were diagnosed as knee osteoarthritis by American College of Rheumatology (ACR) guideline criteria, at the time of screening
- •Subject with Body mass index (BMI) ≤35 kg/m2 at the time of screening
- •Subject with ligament instability ≤Grade II (grade o: no ligament instability, grade I: 0 \~ 5㎜, grade Ⅱ: 5 \~ 10 ㎜, grade Ⅲ: \> 10 ㎜) at the time of screening
- •Subject who agree to maintain contraception during study period
- •Subject who voluntarily agreed to participate in the study, and signed informed consent
Exclusion Criteria
- •Subject with myocardial infarction, congestive heart failure, and other severe heart disease or hypertension (or medical history of hypertension) that are not controlled below 140/90mmHg even with treatment with more than three(3) antihypertensive drugs
- •Subject with serious medical conditions other than cardiovascular disease
- •Subject with, or with a medical history of auto-immune diseases
- •Subject with an infection that requires parenteral antibiotic administration.
- •Subject with a medical history of mental disorder or epilepsy
- •Subject with chronic inflammatory joint diseases such as rheumatoid arthritis (e.g., osteoarthritis with infectious joint disease, gouty arthritis, and osteoarthritis)
- •Subject who had surgery or radiation therapy on knee joint area, or have not recovered from side effects of knee joint surgery within 12 weeks before screening
- •Subject who are pregnant or lactating
- •Subject abuse alcohol 10 times a week or smoke 25 cigarettes a day
- •Subject who were diagnosed with cancer within 5 years before screening
Outcomes
Primary Outcomes
Change of total score in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) compared to baseline at 6 months after treatment
Time Frame: Baseline, Month 6
Change of total scorein WOMAC compared to baseline at 6 months after treatment. WOMAC consists of three subscales: pain, stiffness, and physical function, and is performed on baseline (visit 2) and final (Visit 8) visits. Total of 24 questions are evaluated with 5 questions for pain, 2 questions for stiffness, and 17 questions for physical function. Each question is scored between 0 point (no symptom) \~ 4 points (severe symptoms) scale, and the total score is between 0 point (no symptoms) \~ 96 points (higher score representing worse symptoms).
Secondary Outcomes
- Change of score in WOMAC three subscales (Pain, stiffness, physical function)compared to baseline at 6 months after treatment(Baseline, Month 6)
- Change of score in 100 mm VAS (Visual Analogue Scale) compared to baseline(Baseline, Month 1, Month 2, Month 3, Month 6)
- Change of score in IKDC(International Knee Documentation Committee)compared to baseline(Baseline, Month 1, Month 2, Month 3, Month 6)
- Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) compared to baseline at 6 months after treatment(Baseline, Month 6)
- Change in K&L(Kellgren-Lawrence) grade compared to the baseline at 3 months and 6 months after treatment(Baseline, Month 3, Month 6)
- Change in joint space width compared to the baseline at 3 months and 6 months after treatment(Baseline, Month 3, Month 6)
- Change in mechanical axis, anatomical axis compared to the baseline at 3 months and 6 months after treatment(Baseline, Month 3, Month 6)