Status:
RECRUITING
The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
Lead Sponsor:
Sclnow Biotechnology Co., Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief 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 explori...
Detailed Description
This is a random, open label, and parallel controled experiment. All patients are selected and sign consent forms, then divided into 3 groups. Doctors collect the basic information of patient. All pat...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03383081
Start Date
October 1 2018
End Date
December 31 2026
Last Update
December 4 2025
Active Locations (1)
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1
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008