Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis
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|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
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|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
Intraarticular injection of hyaluronic acid
Other: Hyaluronic acid
intra-articular injection of Hyaluronic Acid
- Change From Baseline in visual analogue scale (VAS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]Visual analogue scale (VAS)
- Change From Baseline in western Ontario and McMaster Universities Osteoarthritis Index score [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]WOMAC
- Change From Baseline in knee society score (KSS) [ Time Frame: Baseline, 1, 3, 6 and 12 weeks ]knee society score (KSS)
- 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)
- The number of cartilage defects, thickness of cartilage evaluated by X-ray and MRI [ 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 [ 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
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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|
- 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.
- 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.
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
|Contact: Changhui Zhou, Ph.D.||email@example.com|
|Liaocheng city people's hospital||Recruiting|
|Liaocheng, Shandong, China, 0635|
|Contact: Changhui Zhou, Ph.D. 86-0635-8272202 firstname.lastname@example.org|
|Study Director:||Dawang Wang, Ph.D.||Liaocheng People's Hospital|
|Responsible Party:||Liaocheng People's Hospital|
|Other Study ID Numbers:||
|First Posted:||May 25, 2017 Key Record Dates|
|Last Update Posted:||June 4, 2018|
|Last Verified:||June 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
mesenchymal stem cells(MSC)
Physiological Effects of Drugs