Back to resultsClinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
Primary Purpose
Defect of Articular Cartilage, Knee Osteoarthritis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ReJoinTM
Sodium Hyaluronate
Sponsored by
About this trial
This is an interventional treatment trial for Defect of Articular Cartilage focused on measuring adipose-derived mesenchymal progenitor cells, Artz
Eligibility 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
Sites / Locations
- Shanghai ninth people's hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ReJoinTM Group
Sodium Hyaluronate Group
Arm Description
Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
Outcomes
Primary Outcome Measures
WOMAC scores
WOMAC scoring will be performed 48 weeks after the first injection
Secondary Outcome Measures
VAS scores
VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
SF-36 scores
SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Outbridge scoring
Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
CRP
Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Cartilage defect size
Cartilage defect size will be measured at 24 weeks after the first injection
Cartilage volume
Cartilage volume will be measured at 24 weeks after first injection
Full Information
NCT ID
NCT02855073
First Posted
July 8, 2016
Last Updated
December 14, 2018
Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1. Study Identification
Unique Protocol Identification Number
NCT02855073
Brief Title
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
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 Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage, Knee Osteoarthritis
Keywords
adipose-derived mesenchymal progenitor cells, Artz
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ReJoinTM Group
Arm Type
Experimental
Arm Description
Subjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
Arm Title
Sodium Hyaluronate Group
Arm Type
Active Comparator
Arm Description
subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
Intervention Type
Biological
Intervention Name(s)
ReJoinTM
Other Intervention Name(s)
adipose derived mesenchymal progenitor cells
Intervention Description
adipose derived mesenchymal progeinitor cells
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Other Intervention Name(s)
Artz
Intervention Description
Sodium Hyaluronate Injection
Primary Outcome Measure Information:
Title
WOMAC scores
Description
WOMAC scoring will be performed 48 weeks after the first injection
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
VAS scores
Description
VAS scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Time Frame
0 day、8 weeks、24 weeks、36 weeks and 48 weeks
Title
SF-36 scores
Description
SF-36 scoring will be performed 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Time Frame
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Title
Outbridge scoring
Description
Outbridge scoring will be performed 24 weeks after the first injection under arthroscopy
Time Frame
1 day and 24 weeks
Title
CRP
Description
Serum CRP levels will be tested 8 weeks、24 weeks、36 weeks and 48 weeks after the first injection
Time Frame
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Title
Cartilage defect size
Description
Cartilage defect size will be measured at 24 weeks after the first injection
Time Frame
0 day and 24 weeks
Title
Cartilage volume
Description
Cartilage volume will be measured at 24 weeks after first injection
Time Frame
0 day and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
You Wang
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai ninth people's hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32043426
Citation
Qiao Z, Tang J, Yue B, Wang J, Zhang J, Xuan L, Dai C, Li S, Li M, Xu C, Dai K, Wang Y. Human adipose-derived mesenchymal progenitor cells plus microfracture and hyaluronic acid for cartilage repair: a Phase IIa trial. Regen Med. 2020 Jan;15(1):1193-1214. doi: 10.2217/rme-2019-0068. Epub 2020 Feb 11.
Results Reference
derived
Learn more about this trial
Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
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