The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
Recruiting now · Phase 2
Conditions studied: Osteoarthritis, Knee
In brief
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
Key facts
- Study ID
- NCT03383081
- Run by
- Sclnow Biotechnology Co., Ltd.
- People needed
- 60
- Starts
- 2018-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-12-04
Who can join
Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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