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

Peking University

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Biological: Hyaluronic Acid; Biological: Mesenchymal Stem Cells from adipose

Study type: Interventional

Funder types: Other

Identifiers

NCT03357575

PUPH20170912

Details and patient eligibility

About

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).

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

Mesenchymal Stem Cells from adipose

Experimental group

Description:

Mesenchymal Stem Cells from adipose will be injected.

Treatment:

Biological: Mesenchymal Stem Cells from adipose

hyaluronic acid

Active Comparator group

Description:

Hyaluronic acid will be injectied.

Treatment:

Biological: Hyaluronic Acid