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

NCT ID: NCT03357575

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Keywords

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Knee Osteoarthritis adipose mesenchymal stem cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mesenchymal Stem Cells from adipose

Mesenchymal Stem Cells from adipose will be injected.

Group Type EXPERIMENTAL

Mesenchymal Stem Cells from adipose

Intervention Type BIOLOGICAL

inject mesenchymal Stem Cells from adipose

hyaluronic acid

Hyaluronic acid will be injectied.

Group Type ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type BIOLOGICAL

inject hyaluronic acid

Interventions

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Mesenchymal Stem Cells from adipose

inject mesenchymal Stem Cells from adipose

Intervention Type BIOLOGICAL

Hyaluronic Acid

inject hyaluronic acid

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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yangziyi

arthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ziyi Yang

Role: PRINCIPAL_INVESTIGATOR

arthritis clinic and research center

Central Contacts

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Ziyi Yang, MD

Role: CONTACT

Phone: 18810335110

Email: [email protected]

Other Identifiers

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PUPH20170912

Identifier Type: -

Identifier Source: org_study_id