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

This study is not yet open for participant recruitment.
Verified November 2017 by yangziyi, Peking University People's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03357575
First Posted: November 30, 2017
Last Update Posted: November 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
yangziyi, Peking University People's Hospital
  Purpose
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).

Condition Intervention
Knee Osteoarthritis Biological: Mesenchymal Stem Cells from adipose Biological: Hyaluronic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by yangziyi, Peking University People's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • VAS score [ Time Frame: 2 years ]
    VAS score decrease 3 points or more

  • WOMAC score [ Time Frame: 2 years ]
    two or more terms of WOMAC score have improvement.


Estimated Enrollment: 14
Anticipated Study Start Date: January 1, 2018
Estimated Study Completion Date: December 1, 2020
Estimated Primary Completion Date: June 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal Stem Cells from adipose
Mesenchymal Stem Cells from adipose will be injected.
Biological: Mesenchymal Stem Cells from adipose
inject mesenchymal Stem Cells from adipose
Active Comparator: hyaluronic acid
Hyaluronic acid will be injectied.
Biological: Hyaluronic Acid
inject hyaluronic acid

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357575


Contacts
Contact: Ziyi Yang, MD 18810335110 bjmuyangziyi@163.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Ziyi Yang arthritis clinic and research center
  More Information

Responsible Party: yangziyi, arthritis clinic and research center, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03357575     History of Changes
Other Study ID Numbers: PUPH20170912
First Submitted: November 25, 2017
First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by yangziyi, Peking University People's Hospital:
Knee Osteoarthritis
adipose
mesenchymal stem cells

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents