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

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. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs) Other: Hyaluronic acid Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)
 Biological: Umbilical-cord mesenchymal stromal cells (UC-MSCs)
Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
Control group
Intraarticular injection of hyaluronic acid
 Other: Hyaluronic acid
intra-articular injection of Hyaluronic Acid


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in visual analogue scale (VAS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    Visual analogue scale (VAS)

  2. Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    WOMAC

  3. Change From Baseline in knee society score (KSS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
    knee society score (KSS)

  4. 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)


Secondary Outcome Measures :
  1. The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]
  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03166865


Contacts
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Contact: Changhui Zhou, Ph.D. 86-0635-8272202 zhouchanghui008@163.com

Locations
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China, Shandong
Liaocheng city people's hospital Recruiting
Liaocheng, Shandong, China, 0635
Contact: Changhui Zhou, Ph.D.    86-0635-8272202    zhouchanghui008@163.com   
Sponsors and Collaborators
Liaocheng People's Hospital
Investigators
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Study Director: Dawang Wang, Ph.D. Liaocheng People's Hospital
More Information
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Responsible Party: Liaocheng People's Hospital
ClinicalTrials.gov Identifier: NCT03166865    
Other Study ID Numbers: lcsrmyygk
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liaocheng People's Hospital:
osteoarthritis (OA)
mesenchymal stem cells(MSC)
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents