Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 17, 2018
December 1, 2018
5.4 years
July 8, 2016
December 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC scores
WOMAC scoring will be performed 48 weeks after the first injection
48 weeks
Secondary Outcomes (6)
VAS scores
0 day、8 weeks、24 weeks、36 weeks and 48 weeks
SF-36 scores
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Outbridge scoring
1 day and 24 weeks
CRP
0 day、8 weeks、24 weeks、 36 weeks and 48 weeks
Cartilage defect size
0 day and 24 weeks
- +1 more secondary outcomes
Study Arms (2)
ReJoinTM Group
EXPERIMENTALSubjects in this Group will receive ReJoinTM injections on day 1 and day 22, and Sodium Hyaluronate injection on day 8 and day 15.
Sodium Hyaluronate Group
ACTIVE COMPARATORsubjects in this group will receive Sodium Hyaluronate injections on day 1, 8, 15, 22.
Interventions
adipose derived mesenchymal progeinitor cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011, China
Related Publications (1)
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.
PMID: 32043426DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
You Wang
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
August 4, 2016
Study Start
July 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
December 17, 2018
Record last verified: 2018-12