The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis
NCT ID: NCT03383081
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2018-10-01
2026-12-31
Brief Summary
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Detailed Description
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Safety evaluation. Researcher collect all examination data of patients and compare with each groups. The safety tests including blood routine, urine routine, hepatorenal function, C reactive protein, erythrocyte sedimentation rate, and tumor marker, etc.
Efficacy evaluation. Based on Lysholm, the international knee documentation committee (IKDC) knee evaluation form, and Visual Analogue Scale/Score (VAS) to examine the change/improvement of knee joint function. By Magnetic Resonance Imaging (MRI) examination, grade patients with Kellgren-Lawrence Grading Scale, Assessment of Preoperative Cartilage Defect Severity (AMADEUS), and observe the change/improvement of patient.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low dose mesenchymal stem cells
Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Low dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);
Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
High dose mesenchymal stem cells
High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
High dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)
Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Control groups
No intervention
No interventions assigned to this group
Interventions
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Low dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);
High dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)
Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Sclnow Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hongbin Lu
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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Xiangya Hospital Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCLnow-XY-02
Identifier Type: -
Identifier Source: org_study_id
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