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

April 18, 2024 updated by: Sclnow Biotechnology Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control groups
No intervention
Experimental: Low dose mesenchymal stem cells
Low dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Biological: Low dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml);
Procedure: Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Experimental: High dose mesenchymal stem cells
High dose group: intra-articular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#)
Procedure: Intraarticular injection
Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
Biological: High dose mesenchymal stem cells
Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kellgren-Lawrence Grading Scale
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Preoperative Cartilage Defect Severity (AMADEUS)
Time Frame: 12 months
Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).
12 months
Lysholm scoring
Time Frame: 12 months
Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.
12 months
The international knee documentation committee (IKDC) knee evaluation form
Time Frame: 12 months
The international knee documentation committee knee evaluation form is used to assess the knee function of patients, examine the changes or improvement compare to baseline.
12 months
Visual Analogue Scale/Score（VAS）
Time Frame: 12 months
Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sclnow Biotechnology Co., Ltd.

Investigators

  • Principal Investigator: Hongbin Lu, Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCLnow-XY-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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