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

Primary Purpose

Osteoarthritis, Knee

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Low dose mesenchymal stem cells

High dose mesenchymal stem cells

Intraarticular injection

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, mesenchymal stem cell

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xiangya Hospital Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Low dose mesenchymal stem cells

High dose mesenchymal stem cells

Control groups

Arm Description

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

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

No intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assessment of Preoperative Cartilage Defect Severity (AMADEUS)

Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).

Lysholm scoring

Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.

The international knee documentation committee (IKDC) knee evaluation form

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.

Visual Analogue Scale/Score（VAS）

Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.

Full Information

NCT ID

NCT03383081

First Posted

December 12, 2017

Last Updated

April 11, 2023

Sponsor

Sclnow Biotechnology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03383081

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sclnow Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

osteoarthritis, mesenchymal stem cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose mesenchymal stem cells

Arm Type

Experimental

Arm Description

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

Arm Title

High dose mesenchymal stem cells

Arm Type

Experimental

Arm Description

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

Arm Title

Control groups

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Biological

Intervention Name(s)

Low dose mesenchymal stem cells

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

High dose mesenchymal stem cells

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Intraarticular injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Kellgren-Lawrence Grading Scale

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Assessment of Preoperative Cartilage Defect Severity (AMADEUS)

Description

Using Magnetic Resonance Imaging (MRI) examination to diagnose patients by Assessment of Preoperative Cartilage Defect Severity (AMADEUS).

Time Frame

12 months

Title

Lysholm scoring

Description

Using Lysholm Knee Scoring Scale to grade the knee function of patients, and examine the changes or improvement compare to baseline.

Time Frame

12 months

Title

The international knee documentation committee (IKDC) knee evaluation form

Description

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.

Time Frame

12 months

Title

Visual Analogue Scale/Score（VAS）

Description

Using Visual Analogue Scale/Score for pain to examine the change/improvement of knee joint function.

Time Frame

12 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lei Guo

Phone

861064368977

georgeguo@sclnow.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongbin Lu

Organizational Affiliation

Xiangya Hospital of Central South University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangya Hospital Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410008

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongbin Lu

Phone

15874889777

hongbinlu@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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