Clinical trial NCT05000593: Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Official title: Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Cord Blood Mononuclear Cells
Knee Osteoarthritis
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Umbilical cord blood mononuclear cells contain hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), endothelial progenitor cells and other pluripotent stem cells, as well as immature immune cells, which can differentiate into chondrocytes, hematopoietic, epithelial, endothelial and nerve cells. It gives the ability to promote wound healing and vascular microcirculation reconstruction, and has the potential to treat many diseasesHowever, clinical studies on cord blood mononuclear cells in knee osteoarthritis have not been reported in the literature. Therefore, this study aims to explore the safety and effectiveness of cord blood mononuclear cells in the treatment of patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age ≥30 years old, ≤75 years old, no gender limit;
* 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:

* Age\<30 years old;
* 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.

Primary outcomes:
measure: Lysholm score
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
measure: American knee society knee score
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
measure: the knee injury and osteoarthritis score
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
measure: Visual Analog Score for pain
timeFrame: Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.