Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000593
• Other study ID #: YXLL-KY-2020(040)
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• normal saline
Intra-articular injection of normal saline
• Cord Blood Mononuclear Cells (UCB-MNCs)
Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)

Locations

Country	Name	City	State
China	Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Lili Cao

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lysholm score	Evaluation of functional perception of daily activities and motor function levels of different intensities.The score ranges from 0 to 100 points, the lower the score, the more severe the knee joint damage.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Primary	American knee society knee score	Evaluation of the overall function and shape of the knee joint.The score ranges from 0 to 100 points. The lower the score, the worse the knee joint function.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Primary	the knee injury and osteoarthritis score	A questionnaire for evaluating the effectiveness of knee joint injury and osteoarthropathy treatment based on patient self-assessment management.The KOOS score consists of five parts, and each part contains a different number of questions. Each question has a minimum of 0 points and a maximum of 4 points. After the score of each part is calculated separately, it is converted into a percentile score through the conversion formula. A score of 0 in the converted percentile score means that the function of that part of the joint is extremely poor, and a score of 100 means that the function of this part of the joint is completely normal.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Primary	Visual Analog Score for pain	Physicians Global Assessment to measure quality of life.The score ranges from 0 to 10 points, the lower the score, the more severe the pain.	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)