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

Who is this study for? Patients with Knee Osteoarthritis
What treatments are being studied? Umbilical Cord-Derived Mesenchymal Stem Cells
Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Xiangya Hospital Central South University
RECRUITING
Changsha
Contact Information
Primary
Lei Guo
georgeguo@sclnow.com
861064368977
Time Frame
Start Date: 2018-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Low dose mesenchymal stem cells
Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Experimental: High dose mesenchymal stem cells
High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
No_intervention: Control groups
No intervention
Authors
Hongbin Lv
Related Therapeutic Areas
Sponsors
Leads: Sclnow Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov