- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03166865
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 Contact
- Name: Changhui Zhou, Ph.D.
- Phone Number: 86-0635-8272202
- Email: zhouchanghui008@163.com
Study Locations
-
-
Shandong
-
Liaocheng, Shandong, China, 0635
- Recruiting
- Liaocheng city people's hospital
-
Contact:
- Changhui Zhou, Ph.D.
- Phone Number: 86-0635-8272202
- Email: zhouchanghui008@163.com
-
-
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)
|
Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
|
OTHER: Control group
Intraarticular injection of 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
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
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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