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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02855073
Recruitment Status : Active, not recruiting
First Posted : August 4, 2016
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Tracking Information
First Submitted Date  ICMJE July 8, 2016
First Posted Date  ICMJE August 4, 2016
Last Update Posted Date December 17, 2018
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
WOMAC scores [ Time Frame: 48 weeks ]
WOMAC scoring will be performed 48 weeks after the first injection
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02855073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
  • 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
  • Outbridge scoring [ Time Frame: 1 day and 24 weeks ]
    Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
  • 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
  • Cartilage defect size [ Time Frame: 0 day and 24 weeks ]
    Cartilage defect size will be measured at 24 weeks after the first injection
  • Cartilage volume [ Time Frame: 0 day and 24 weeks ]
    Cartilage volume will be measured at 24 weeks after first injection
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • 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
  • 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
  • Outbridge scoring [ Time Frame: 1 day and 24 weeks ]
    Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Defect of Articular Cartilage
  • Knee Osteoarthritis
Intervention  ICMJE
  • Biological: ReJoinTM
    adipose derived mesenchymal progeinitor cells
    Other Name: adipose derived mesenchymal progenitor cells
  • Drug: Sodium Hyaluronate
    Sodium Hyaluronate Injection
    Other Name: Artz
Study Arms  ICMJE
  • 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.
    Intervention: Biological: ReJoinTM
  • Active Comparator: Sodium Hyaluronate Group
    subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
    Intervention: Drug: Sodium Hyaluronate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2016)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02855073
Other Study ID Numbers  ICMJE CBMG-ReJoinTM-CL-1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cellular Biomedicine Group Ltd.
Study Sponsor  ICMJE Cellular Biomedicine Group Ltd.
Collaborators  ICMJE Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators  ICMJE
Study Director: You Wang Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
PRS Account Cellular Biomedicine Group Ltd.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP