KCT0005269招募中未知
An open-label, phased-increasing dose, Phase 1/2a clinical trial to evaluate the safety and efficacy of allogeneic placenta-derived mesenchymal stem cell therapy (PLARTISTEM®) in patients with osteoarthritis
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Subjects who diagnosed as osteoarthritis based on ACR criteria
- •2. Subjects who are scheduled to undergo microfracture treatment for cartialge defect due to osteoarthritis
- •3. Kellegren & Lawrence Grade 2-3
- •4. Arthrscopy confirmed ICRS grade 3 or 4 cartilage lesion
- •5. No improvement of symptoms by nonoperative treatment for at least 3 months
- •6. Pain on the target knee > 40 mm on VAS at screening
- •7. Adults of age 20 or older
- •8. Major cartilage defect size 2 ? ~ 9 ? at one compartment showing most prominent symptoms
- •9. More painful knees in case of bilateral knee pain
- •10. BMI between 18-35
- •11. No clinically significant abnormal findings in physical exam, blood lab tests, and urine lab tests
- •12. Female subjects who consented to contraception during the Part I study period
- •13. Subjects who are willing to participate in this study and signed the informed consent form
排除标准
- •1. BMI =35?/? at screening visit
- •2. Taking psychotropic substance or opioid pain killer for the recent 3 months
- •3. Clinical significant abnormal lab test results at screening
- •4. Rheumatoid arthritis or other inflammatory or metabolic arthritis
- •5. Any signs of infection at the target knee or around the joint
- •6. Secondary arthrtiis due to Ochronosis, Hemochromatosis, or other systemic disease
- •7. Subjects with significant pain such as Sudeck’s atrophy, Paget’s disease, fibromyalgia, or CRPS
- •8. Signifcant deformity of the knee due to osteoarthhritis (HKA angle deviation > 10 degree)
- •9. Subjects with significant pain at other joints(hip, spine, etc) that may affect knee pain
- •10. Subjects with significant pain at the other knee that the investigator considers inappropriate to be enrolled in this study
- •11. Administraion of the below found at screeing visit
- •1) Hyaluronic acid injection at the target knee or other joint within 6 month
- •2) Steroid injection at the target knee within 3 months
- •3) Systemic administration of steroid within 1 month (except inhalant)
- •12. History of arthroscopic or open surgery at the target knee within 1 year (except arthroscopic examination only)
- •13. History of replacement surgery at the target knee
- •14. Subjects who have to use anticoagulant (except low dose aspiring, daily dose less than 300 mg)
- •15. Grade II or more ligament laxity at the target knee
- •16. History of allergy to Hyaluronate or Gentamicin
- •17. Subjects who need to take immunosuppressant or who took immunosuppressant such as Cyclosprin A or Azathioprine within 6 weeks
- •18. Subjects who had taken other cell therapy product
- •19. Female subjects who do not agree contraception during the part I trial period
- •20. Subjects who are pregnant or on breast feeding
- •21. Subjects participating in another clinical trial in during the trial period
- •22. Subjects deemed inappropriate by the investigator other than the above items
研究者
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