The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
1 other identifier
interventional
14
0 countries
N/A
Brief Summary
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Jan 2018
Longer than P75 for not_applicable knee-osteoarthritis
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
First Submitted
Initial submission to the registry
November 25, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedNovember 30, 2017
November 1, 2017
2.4 years
November 25, 2017
November 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Unexplained local and systemic symptoms or death
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
2 years
Secondary Outcomes (2)
VAS score
2 years
WOMAC score
2 years
Study Arms (2)
Mesenchymal Stem Cells from adipose
EXPERIMENTALMesenchymal Stem Cells from adipose will be injected.
hyaluronic acid
ACTIVE COMPARATORHyaluronic acid will be injectied.
Interventions
inject mesenchymal Stem Cells from adipose
Eligibility Criteria
You may qualify if:
- K / L score of 2-3;
- chronic knee pain;
- no local or systemic infection;
- without obvious contraindication of the joint puncture from hematology and biochemical tests;
- informed consent.
You may not qualify if:
- older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
- HIV, hepatitis virus or syphilis virus infection or their serology is positive;
- BMI index is greater than 30;
- congenital or acquired knee deformity;
- pregnant or lactating women;
- tumor patients;
- immunodeficiency patients;
- intra-articular drug injection history within 3 months;
- participating in other clinical trials;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziyi Yang
arthritis clinic and research center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- arthritis clinic and research center
Study Record Dates
First Submitted
November 25, 2017
First Posted
November 30, 2017
Study Start
January 1, 2018
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
November 30, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share