Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects

December 14, 2018 updated by: Cellular Biomedicine Group Ltd.

A Randomized, Single-blind, Phase II Clinical Trial to Compare ReJoinTM (Autologous Adipose-derived Mesenchymal Progenitor Cells)to Sodium Hyaluronate Injection for the Patients With Knee Osteoarthritis Cartilage Defects

The purpose of this study is to evaluate the effectiveness of ReJoinTM for the Knee Osteoarthritis patients with Cartilage Defects comparing to Sodium Hyaluronate Injection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, single-blind,phase II clinical trial.

At least 28 subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects will be randomly distributed 1:1 to the treatment group or the control group after signing the ICF and screening tests.The treatment will accept ReJoinTM at the first and fourth week,and Sodium Hyaluronate Injection at the second and third week.The control group will accept Sodium Hyaluronate Injection weekly ,and four injections in total.The duration of the therapy is 48 weeks.

In addition, external control will be added if necessary.

Study Type

Interventional

Enrollment (Anticipated)

28

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Shanghai Ninth People's Hospital

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 years old, KOA couse ≤ 10 years
  • Kellgren-Lawrence Ⅰ-Ⅲ
  • VAS core >6， more than 4 months
  • Signed informed consent from the subject
  • cartilage defect 2-6cm2

Exclusion Criteria:

  • Pregnancy test positive.
  • Subject infected with hepatitis C, HIV or syphilis.
  • Subject enrolled in any other cell therapy studies within the past 30 days.
  • Subject deemed to be not suitable for the study by the investigator

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ReJoinTM Group
Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
Biological: ReJoinTM
adipose derived mesenchymal progeinitor cells
Other Names:
  • adipose derived mesenchymal progenitor cells
Active Comparator: Sodium Hyaluronate Group
subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
Drug: Sodium Hyaluronate
Sodium Hyaluronate Injection
Other Names:
  • Artz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC scores
Time Frame: 48 weeks
WOMAC scoring will be performed 48 weeks after the first injection
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS scores
Time Frame: 0 day、8 weeks、24 weeks、36 weeks and 48 weeks
VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
0 day、8 weeks、24 weeks、36 weeks and 48 weeks
SF-36 scores
Time Frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Outbridge scoring
Time Frame: 1 day and 24 weeks
Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
1 day and 24 weeks
CRP
Time Frame: 0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Cartilage defect size
Time Frame: 0 day and 24 weeks
Cartilage defect size will be measured at 24 weeks after the first injection
0 day and 24 weeks
Cartilage volume
Time Frame: 0 day and 24 weeks
Cartilage volume will be measured at 24 weeks after first injection
0 day and 24 weeks

Collaborators and Investigators

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

Sponsor

Cellular Biomedicine Group Ltd.

Collaborators

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

  • Study Director: You Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

August 1, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 14, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBMG-ReJoinTM-CL-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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