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The Safety/Efficacy of hUC Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:
A Clinical Research on the Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells（19#iSCLife®-OA） Therapy for Patients With Osteoarthritis

Clinical Trial 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

Clinical Trial 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 patients receive laboratory and image examination as baseline. Then, they will give cell treatment based on the clinical protocol. Doctors have follow-up visit on 2 weeks, 1, 2, 3, 6, and 12 months after treatment, and do safety and efficacy evaluation. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03383081
Study type Interventional
Source Sclnow Biotechnology Co., Ltd.
Contact Lei Guo
Phone 861064368977
Email georgeguo@sclnow.com
Status Recruiting
Phase Phase 2
Start date October 1, 2018
Completion date June 30, 2025
View Details
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