Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
NCT ID: NCT02855073
Last Updated: 2018-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
28 participants
INTERVENTIONAL
2014-07-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
ReJoinTM
adipose derived mesenchymal progeinitor cells
Sodium Hyaluronate Group
subjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
Sodium Hyaluronate
Sodium Hyaluronate Injection
Interventions
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ReJoinTM
adipose derived mesenchymal progeinitor cells
Sodium Hyaluronate
Sodium Hyaluronate Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Kellgren-Lawrence Ⅰ-Ⅲ
* VAS core \>6， more than 4 months
* Signed informed consent from the subject
* cartilage defect 2-6cm2
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Shanghai AbelZeta Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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You Wang
Role: STUDY_DIRECTOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
Other Identifiers
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CBMG-ReJoinTM-CL-1.0
Identifier Type: -
Identifier Source: org_study_id