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Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03166865
Recruitment Status : Unknown
Verified June 2018 by Liaocheng People's Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Liaocheng People's Hospital

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 25, 2017
Last Update Posted Date June 4, 2018
Estimated Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • Change From Baseline in visual analogue scale (VAS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    Visual analogue scale (VAS)
  • Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    WOMAC
  • Change From Baseline in knee society score (KSS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    knee society score (KSS)
  • Change From Baseline in MOS item short from health survey(SF-36) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    The MOS item short from health survey(SF-36)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
  • The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
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 Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Official Title  ICMJE Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Brief Summary Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of the Knee
Intervention  ICMJE
  • Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)
    Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
  • Other: Hyaluronic acid
    intra-articular injection of Hyaluronic Acid
Study Arms  ICMJE
  • Experimental: Intervention group
    Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)
    Intervention: Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)
  • Control group
    Intraarticular injection of hyaluronic acid
    Intervention: Other: 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 30-70 years old.
  • No serious infection, chronic diseases, diabetes and tuberculosis.
  • Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
  • Written informed consents were obtained from all subjects.

Exclusion Criteria:

  • Pregnant women or cognitively impaired adults.
  • Inflammatory or post infectious arthritis.
  • Intra-articular drug injection within the previous 2 months.
  • Serious medical illness with a life expectancy of less than 1 year.
  • Prior admission for substance abuse.
  • Arthroscopy during the previous 6 months.
  • Systemic autoimmune rheumatic disease.
  • Poorly controlled diabetes mellitus.
  • Immunosuppressive or anticoagulant treatments.
  • Treatment with corticosteroids in the 3 months prior to inclusion in the study.
  • NSAID therapy within 15 days prior to inclusion in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03166865
Other Study ID Numbers  ICMJE lcsrmyygk
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 Not Provided
Responsible Party Liaocheng People's Hospital
Study Sponsor  ICMJE Liaocheng People's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dawang Wang, Ph.D. Liaocheng People's Hospital
PRS Account Liaocheng People's Hospital
Verification Date June 2018

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