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The Safety/Efficacy of hUC Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis
RECRUITINGPhase 2Sponsored by Sclnow Biotechnology Co., Ltd.
Actively Recruiting
PhasePhase 2
SponsorSclnow Biotechnology Co., Ltd.
Started2018-10-01
Est. completion2026-06-30
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03383081
Summary
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
Eligibility
Healthy volunteers accepted
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
Conditions2
ArthritisOsteoarthritis, Knee
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Actively Recruiting
PhasePhase 2
SponsorSclnow Biotechnology Co., Ltd.
Started2018-10-01
Est. completion2026-06-30
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03383081