KCT0008423尚未招募Unknown
Evaluation of the efficacy of autologous adipose-derived stem cells with hyaluronic acid injection therapy in patients with knee degenerative arthritis
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. At the date of written consent, male and female adults between the ages of 40 and 70
- •2. Knee according to American College of Rheumatology (ACR) criteria at the screening visit those with osteoarthritis who have had knee pain for at least 2 months
- •3. X-ray of knee osteoarthritis site (Target Lesion) in screening examination those who meet the examination criteria (Kellgren & Lawrence Grade, KL Grade) of Grade II, Grade III, or IV
- •4. A person who has a pain score of 4 or more as a Visual Analog Scale (VAS) pain score during activity of the knee osteoarthritis site (Target Lesion) scheduled for administration at the screening visit
- •5. Patients with unilateral knee osteoarthritis or bilateral knee osteoarthritis, bilateral knee osteoarthritis in the case of a patient, a person who can designate the treatment target knee to one side according to the criteria (1 to 4) presented above. However, if both knees meet the selection/exclusion criteria, both knees are selected as study subjects, and the test group and control group are randomly assigned to the left and right sides, respectively, but each knee (right and left knee of one subject) Assign individual subject codes for
- •6. A person who understands the purpose of this clinical study, voluntarily decides to participate in the clinical study, and agrees in writing to abide by the restrictions
排除标准
- •Those who meet any of the following criteria are excluded from the research subjects.
- •1. Patients with secondary knee osteoarthritis caused by other diseases such as infectious or rheumatoid arthritis, not primary degenerative knee osteoarthritis
- •2. Diseases that can affect joint pain and prognosis [gout, recurrent pseudogout, joint
- •Those with fractures, hemochromatosis, Wilson's disease, genetic diseases (e.g., hyperkinesia), collagen gene abnormalities, etc.]
- •3. Subjects with a Body Mass Index (BMI) of 33.3 kg/m2 or higher at the time of screening
- •4. Those who have undergone artificial joint surgery (total knee arthroplasty (TKA) or partial arthroplasty (UKA)) for knee osteoarthritis (treatment target knee) prior to the screening visit date, (proximal tibial osteotomy, partial meniscal resection, etc.) Those who have passed more than 6 months after the surgical treatment of
- •5. A person who meets one or more of the following items before the first injection date
- •- Intra-articular injection of high-crossover hyaluronic acid, cell therapy, and gene therapy to the treatment target knee within the previous 6 months
- •- Intra-articular injection of cross-linked hyaluronic acid and steroids to the target knee area within the previous 3 months
- •- Non-Steroidal Anti-Inflammatory Drug (NSAID) or glucosamine within the previous 14 days;
- •chondroitin sulfate, oral steroids
- •6. Uncontrolled type 1 or type 2 diabetes on the day of the screening visit [at screening
- •Glycated Hemoglobin (HbA1c) > 8.5%]
- •8. Positive Human Immunodeficiency Virus (HIV) antibody test result on the day of the screening visit
- •9. Those with a history of malignant tumor within 3 years prior to the date of screening visit
- •10. Those who have participated in other clinical studies within 60 days prior to the date of screening visit
- •11. As a result of the screening test, the researcher judged to have clinically meaningful abnormal findings that are not suitable for participation in clinical research
- •12. A person who has a mental illness (alcohol or drug addiction) and judges that the researcher may have low compliance, cause problems with the safety of research subjects, or cause confusion in the interpretation of clinical research results
- •13. Pregnant and lactating women
- •14. Women and men of childbearing potential who plan to conceive during the clinical study period or do not intend to use appropriate contraceptive methods*
- •*? Hormonal contraceptives, ? Implantation of an intrauterine device or intrauterine system, ? Double barrier method with spermicide [using both a male condom and a closure cap (contraceptive vaginal diaphragm or cervical cap)], ? Infertility treatment (vasectomy, bilateral tubal ligation, etc.)
- •15. Persons who are judged unsuitable for participation in clinical research by other principal investigators
研究者
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