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

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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.

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.

Condition or disease Intervention/treatment Phase
Defect of Articular Cartilage Knee Osteoarthritis Biological: ReJoinTM Drug: Sodium Hyaluronate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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 Name: Artz




Primary Outcome Measures :
  1. WOMAC scores [ Time Frame: 48 weeks ]
    WOMAC scoring will be performed 48 weeks after the first injection


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Outbridge scoring [ Time Frame: 1 day and 24 weeks ]
    Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy

  4. 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

  5. Cartilage defect size [ Time Frame: 0 day and 24 weeks ]
    Cartilage defect size will be measured at 24 weeks after the first injection

  6. Cartilage volume [ Time Frame: 0 day and 24 weeks ]
    Cartilage volume will be measured at 24 weeks after first injection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855073


Locations
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China, Shanghai
Shanghai ninth people's hospital
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Director: You Wang Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT02855073     History of Changes
Other Study ID Numbers: CBMG-ReJoinTM-CL-1.0
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cellular Biomedicine Group Ltd.:
adipose-derived mesenchymal progenitor cells
Artz
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents