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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

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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