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The Safety/Efficacy of hUC Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis

RecruitingPhase 2Ages any - 70 YearsAllSclnow Biotechnology Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis for exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of Knee Osteoarthritis by Kellgren and Lawrence Grading Scale, classified with Grade 2-3 * Confirm with cartilage injury,articular cartilage part or full-thickness injury, by MR (Magnetic Resonance) * Age \<70, no serious organ dysfunction * Over 2 years knee pain or no very effective with conservative treatments * Knee pain of VAS (visual analog scale score) is 4 or higher * Normal hepatic and renal function, no history of gout, rheumatoid arthritis, and autoimmune diseases, etc. * Understand and sign the consent form of this study Exclusion Criteria: * Refuse to sign the consent form, or cannot keep follow-up visit * Age \>70; Age \<70, but with multiple organ failure * Unstable vital signs (breath, blood pressure, pulse) * Combined with knee ligament (anterior and the posterior cruciate ligament, medial and lateral collateral ligament) rupture, laxity, etc. * Serious bleeding tendency, poor coagulation function (PTA \<35%) * Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment * Participate other clinical experiments in 3 months * With progressing malignant tumor * Combined with shock and critically ill patients * With mental disease, cannot * With history of knee joint infection, surgery, and radiotherapy * With immunosuppressive agents treatment in 6 weeks * Injection with hormones and sodium hyaluronate in joint in 3 months * Overweight expressed as body mass index (BMI) \>35 * With skin disease around knee joint * With Immunodeficiency disease, including long term use immunosuppressive agents patients * Combined with serious infection * With some other conditions that doctor propose not to participate
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What it tests

  • Low dose mesenchymal stem cells
  • High dose mesenchymal stem cells
  • Intraarticular injection
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Where

1 site
Xiangya Hospital Central South University
Changsha, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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