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

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ClinicalTrials.gov Identifier: NCT03357575
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
yangziyi, Peking University People's Hospital

Tracking Information
First Submitted Date  ICMJE November 25, 2017
First Posted Date  ICMJE November 30, 2017
Last Update Posted Date November 30, 2017
Estimated Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
Official Title  ICMJE The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Biological: Mesenchymal Stem Cells from adipose
    inject mesenchymal Stem Cells from adipose
  • Biological: Hyaluronic Acid
    inject hyaluronic acid
Study Arms  ICMJE
  • Experimental: Mesenchymal Stem Cells from adipose
    Mesenchymal Stem Cells from adipose will be injected.
    Intervention: Biological: Mesenchymal Stem Cells from adipose
  • Active Comparator: hyaluronic acid
    Hyaluronic acid will be injectied.
    Intervention: Biological: Hyaluronic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2017)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ziyi Yang, MD 18810335110 bjmuyangziyi@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03357575
Other Study ID Numbers  ICMJE PUPH20170912
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party yangziyi, Peking University People's Hospital
Study Sponsor  ICMJE Peking University People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ziyi Yang arthritis clinic and research center
PRS Account Peking University People's Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP