The Safety/Efficacy of hUC Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 2
Where in China
- Xiangya Hospital Central South UniversityChangsha, ChinaContact: Hongbin LuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sclnow Biotechnology Co., Ltd.
- Trial code
- NCT03383081
- Record updated
- 4 December 2025
- Original description
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 diseaseRead full original descriptionShow less
A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells(19#iSCLife®-OA) Therapy for Patients With Osteoarthritis
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
Inclusion: 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: Pregnant or breast feeding women, or positive pregnancy test in 7 days before treatment; Serious bleeding tendency, poor coagulation function (PTA <35%); With progressing malignant tumor; With mental disease, cannot; With history of knee joint infection, surgery, and radiotherapy; 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; Injection with hormones and sodium hyaluronate in joint in 3 months; Age >70; Age <70, but with multiple organ failure; Refuse to sign the consent form, or cannot keep follow-up visit; 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; Participate other clinical experiments in 3 months; Combined with shock and critically ill patients; With immunosuppressive agents treatment in 6 weeks; Overweight expressed as body mass index (BMI) >35.