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

NCT05000593 | Completed

• 1 other identifier: YXLL-KY-2020(040)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Cord Blood Mononuclear Cells; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

stem cell treating group

EXPERIMENTAL

Intra-articular injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 1 week for a total of 3 times.

Other: normal saline; Other: Cord Blood Mononuclear Cells (UCB-MNCs)

Interventions

normal saline OTHER

Intra-articular injection of normal saline

stem cell treating group

Cord Blood Mononuclear Cells (UCB-MNCs) OTHER

Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)

stem cell treating group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Lili Cao: lead

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 252000, China

Location

Related Publications (5)

• 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.

  PMID: 23744977 BACKGROUND

• 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.

  PMID: 26474054 BACKGROUND

• 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.

  PMID: 29196647 BACKGROUND

• 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.

  PMID: 24462672 BACKGROUND

• 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.

  PMID: 27510262 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dean of orthopeadic department

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: August 11, 2021
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)