A Open, Single-center, Phase 1 Trial to Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change of total score in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) compared to baseline at 6 months after treatment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Subject who particiapted in another clinical trial within 4 weeks before screening of this clinical trial
- •Subject who were administered with immunosuppressnats such as cyclosporin A or azathioprine within 6 weeks before screening
- •Subject who had intra-articular administration such as sodium hyaluronate injections within 6 month before screening
- •Subject who are suffering from skin disease or considered inappropriate for injection in the injection site
- •Subject who has history of allergic response to hyaluronate injections or DMSO (cryopreservative) or Gentamicin (antibiotics)
- •Subject who are consiered inappropriate for MRI assessment with Tesla higher than 3.0
- •Subject with medical history of cell therapy product administration or are scheduled to administer other cell therapy product
- •Subject who principal investigator (PI) considers inappropriate to participate in the study due to any reasons other than those listed above
结局指标
主要结局
Change of total score in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) compared to baseline at 6 months after treatment
时间窗: 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).
次要结局
- 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)