Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
NCT ID: NCT05000593
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2021-02-01
2022-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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stem cell treating group
Intra-articular injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 1 week for a total of 3 times.
normal saline
Intra-articular injection of normal saline
Cord Blood Mononuclear Cells (UCB-MNCs)
Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)
Interventions
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normal saline
Intra-articular injection of normal saline
Cord Blood Mononuclear Cells (UCB-MNCs)
Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)
Eligibility Criteria
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Inclusion Criteria
* Meet the KOA diagnostic criteria in the "Classification Criteria for Knee Osteoarthritis" revised by the American College of Rheumatology (ACR);
* According to the X-ray K-L grading and evaluation standard, it is at level II-III;
* Continuous pain for at least 6 months;
* No local or systemic infection;
* There is no obvious contraindication for articular cavity puncture in hematology and biochemical testing;
* Subjects and their families understand the clinical trial protocol and agree to participate in the trial, voluntarily and sign an informed consent form;
Exclusion Criteria
* Tumor diseases;
* Severe kidney, lung or liver damage;
* Blood diseases include anemia and thrombocytopenia;
* Type I diabetes;
* Severe effusion;
* Contracture or instability of the knee joint, with an axial deformity greater than 10°;
* Infectious arthritis or skin disease;
* Inject corticosteroids and immunosuppressants into the knee joint within 2 months;
* Suffer from mental illness and poor compliance;
* Cases that the investigator thinks are not suitable for inclusion in the group.
30 Years
75 Years
ALL
No
Sponsors
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Lili Cao
OTHER
Responsible Party
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Lili Cao
dean of orthopeadic department
Locations
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Qianfoshan Hospital
Jinan, Shandong, China
Countries
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References
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Prieto-Alhambra D, Judge A, Javaid MK, Cooper C, Diez-Perez A, Arden NK. Incidence and risk factors for clinically diagnosed knee, hip and hand osteoarthritis: influences of age, gender and osteoarthritis affecting other joints. Ann Rheum Dis. 2014 Sep;73(9):1659-64. doi: 10.1136/annrheumdis-2013-203355. Epub 2013 Jun 6.
Tang X, Wang S, Zhan S, Niu J, Tao K, Zhang Y, Lin J. The Prevalence of Symptomatic Knee Osteoarthritis in China: Results From the China Health and Retirement Longitudinal Study. Arthritis Rheumatol. 2016 Mar;68(3):648-53. doi: 10.1002/art.39465.
Wang B, Liu W, Xing D, Li R, Lv C, Li Y, Yan X, Ke Y, Xu Y, Du Y, Lin J. Injectable nanohydroxyapatite-chitosan-gelatin micro-scaffolds induce regeneration of knee subchondral bone lesions. Sci Rep. 2017 Dec 1;7(1):16709. doi: 10.1038/s41598-017-17025-6.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
Burke J, Hunter M, Kolhe R, Isales C, Hamrick M, Fulzele S. Therapeutic potential of mesenchymal stem cell based therapy for osteoarthritis. Clin Transl Med. 2016 Dec;5(1):27. doi: 10.1186/s40169-016-0112-7. Epub 2016 Aug 10.
Other Identifiers
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YXLL-KY-2020(040)
Identifier Type: -
Identifier Source: org_study_id
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