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

Primary Purpose

Osteoarthritis of the Knee

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Umbilical-cord mesenchymal stromal cells (UC-MSCs)
Hyaluronic acid
Sponsored by
Liaocheng People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring osteoarthritis (OA), mesenchymal stem cells(MSC)

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liaocheng city people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)

Intraarticular injection of hyaluronic acid

Outcomes

Primary Outcome Measures

Change From Baseline in visual analogue scale (VAS)
Visual analogue scale (VAS)
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
WOMAC
Change From Baseline in knee society score (KSS)
knee society score (KSS)
Change From Baseline in MOS item short from health survey(SF-36)
The MOS item short from health survey(SF-36)

Secondary Outcome Measures

The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid

Full Information

First Posted
May 23, 2017
Last Updated
June 1, 2018
Sponsor
Liaocheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03166865
Brief Title
Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Official Title
Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liaocheng People's Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
osteoarthritis (OA), mesenchymal stem cells(MSC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intraarticular injection of 2×10~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)
Arm Title
Control group
Arm Type
Other
Arm Description
Intraarticular injection of hyaluronic acid
Intervention Type
Biological
Intervention Name(s)
Umbilical-cord mesenchymal stromal cells (UC-MSCs)
Intervention Description
Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid
Intervention Description
intra-articular injection of Hyaluronic Acid
Primary Outcome Measure Information:
Title
Change From Baseline in visual analogue scale (VAS)
Description
Visual analogue scale (VAS)
Time Frame
Baseline, 1, 3, 6 and 12 weeks
Title
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
Description
WOMAC
Time Frame
Baseline, 1, 3, 6 and 12 weeks
Title
Change From Baseline in knee society score (KSS)
Description
knee society score (KSS)
Time Frame
Baseline, 1, 3, 6 and 12 weeks
Title
Change From Baseline in MOS item short from health survey(SF-36)
Description
The MOS item short from health survey(SF-36)
Time Frame
Baseline, 1, 3, 6 and 12 weeks
Secondary Outcome Measure Information:
Title
The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
Time Frame
Baseline, 1, 3, 6 and 12 weeks
Title
The IL-1β, IL-6, PGE-2, TGF-β, TNF-α and IGF-1 of articular cavity fluid
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changhui Zhou, Ph.D.
Phone
86-0635-8272202
Email
zhouchanghui008@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawang Wang, Ph.D.
Organizational Affiliation
Liaocheng People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Liaocheng city people's hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
0635
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changhui Zhou, Ph.D.
Phone
86-0635-8272202
Email
zhouchanghui008@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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