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

June 1, 2018 updated by: Liaocheng People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Liaocheng, Shandong, China, 0635
        • Recruiting
        • Liaocheng city people's hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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
OTHER: Control group
Intraarticular injection of hyaluronic acid
Other: Hyaluronic acid
intra-articular injection of Hyaluronic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in visual analogue scale (VAS)
Time Frame: Baseline, 1, 3, 6 and 12 weeks
Visual analogue scale (VAS)
Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
Time Frame: Baseline, 1, 3, 6 and 12 weeks
WOMAC
Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in knee society score (KSS)
Time Frame: Baseline, 1, 3, 6 and 12 weeks
knee society score (KSS)
Baseline, 1, 3, 6 and 12 weeks
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)
Baseline, 1, 3, 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
Time Frame: Baseline, 1, 3, 6 and 12 weeks
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
Baseline, 1, 3, 6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaocheng People's Hospital

Investigators

  • Study Director: Dawang Wang, Ph.D., Liaocheng People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2018

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (ACTUAL)

May 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lcsrmyygk

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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