The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Peking University People's Hospital
- Enrollment
- 14
- Primary Endpoint
- Unexplained local and systemic symptoms or death
- Last Updated
- 8 years ago
Overview
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).
Detailed Description
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
Investigators
yangziyi
arthritis clinic and research center
Peking University People's Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
Outcomes
Primary Outcomes
Unexplained local and systemic symptoms or death
Time Frame: 2 years
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.
Secondary Outcomes
- WOMAC score(2 years)
- VAS score(2 years)