Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Ad… (NCT04821102) | Clinical Trial Compass
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Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration
South Korea21 participantsStarted 2023-07-01
Plain-language summary
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Age 20 and older, male and female
✓. Patients must consent in writing to participate in the study by signing and dating an informed consent document
✓. Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
✓. Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
✓. Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
✓. Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
✓. Patient who has WOMAC score ≥ 1000 at Screening
✓. No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening
Exclusion criteria
✕. Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
✕. Pregnant women or lactating mothers
✕. Patients with Body Mass Index (BMI) \> 35
✕. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection