The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Hyaluronic Acid; Biological: Mesenchymal Stem Cells from adipose

• Registration Number: NCT03357575
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30
• Study Start: 2018-01-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hyaluronic acid	Hyaluronic Acid	Hyaluronic acid will be injectied.
Mesenchymal Stem Cells from adipose	Mesenchymal Stem Cells from adipose	Mesenchymal Stem Cells from adipose will be injected.

Primary Outcome Measures

Name	Time	Method
Unexplained local and systemic symptoms or death	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 Outcome Measures

Name	Time	Method
VAS score	2 years	VAS score decrease 3 points or more
WOMAC score	2 years	two or more terms of WOMAC score have improvement.