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

NCT03383081 | Recruiting Phase 2

• 1 other identifier: SCLnow-XY-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 exploring the treatment regimen of UC-MSC therapy in different degree of cartilage defect disease

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• Kellgren-Lawrence Grading Scale

  Using Magnetic Resonance Imaging (MRI) examination, and based on the images of bilateral knee joint, grade by Kellgren-Lawrence Grading Scale. Kellgren-Lawrence Grading Scale is a method of classifying the severity of knee osteoarthritis (OA). Grade 0: No radiographic features of osteoarthritis; Grade 1: Possible joint space narrowing (normal joint space is at least 2 mm at the superior acetabulum) and osteophyte formation; Grade 2: Definite osteophyte formation with possible joint space narrowing; Grade 3: Multiple osteophytes, definite joint space narrowing, sclerosis and possible bony deformity; Grade 4: Large osteophytes, marked joint space narrowing, severe sclerosis and definite bony deformity.

  12 months

Secondary Outcomes (4)

• Assessment of Preoperative Cartilage Defect Severity (AMADEUS)

  12 months

• Lysholm scoring

  12 months

• The international knee documentation committee (IKDC) knee evaluation form

  12 months

• Visual Analogue Scale/Score（VAS）

  12 months

Study Arms (3)

Low dose mesenchymal stem cells

EXPERIMENTAL

Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)

Biological: Low dose mesenchymal stem cells; Procedure: Intraarticular injection

High dose mesenchymal stem cells

EXPERIMENTAL

High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)

Biological: High dose mesenchymal stem cells; Procedure: Intraarticular injection

Control groups

NO INTERVENTION

No intervention

Interventions

Low dose mesenchymal stem cells BIOLOGICAL

Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 \* 10\^7 cells (5ml);

Low dose mesenchymal stem cells

High dose mesenchymal stem cells BIOLOGICAL

Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 \* 10\^7 cells (5ml)

High dose mesenchymal stem cells

Intraarticular injection PROCEDURE

Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group

High dose mesenchymal stem cells; Low dose mesenchymal stem cells

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hongbin Lu

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Guo

CONTACT

861064368977; georgeguo@sclnow.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 26, 2017
• Study Start: October 1, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

CN (1)