Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 25, 2017
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedJune 4, 2018
June 1, 2018
1.7 years
May 23, 2017
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in visual analogue scale (VAS)
Visual analogue scale (VAS)
Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score
WOMAC
Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in knee society score (KSS)
knee society score (KSS)
Baseline, 1, 3, 6 and 12 weeks
Change From Baseline in MOS item short from health survey(SF-36)
The MOS item short from health survey(SF-36)
Baseline, 1, 3, 6 and 12 weeks
Secondary Outcomes (2)
The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI
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
Study Arms (2)
Intervention group
EXPERIMENTALIntraarticular injection of 2×10\~7 Umbilical-cord mesenchimal stem cells with plateler Rich Plasma(5ml)
Control group
OTHERIntraarticular injection of hyaluronic acid
Interventions
Allogeneic UC-MSCs 1 x 10\~7 diluted on 5 mL of Platelet Rich Plasma
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaocheng city people's hospital
Liaocheng, Shandong, 0635, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dawang Wang, Ph.D.
Liaocheng People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 25, 2017
Study Start
October 1, 2018
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
June 4, 2018
Record last verified: 2018-06