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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: normal saline; Other: Cord Blood Mononuclear Cells (UCB-MNCs)

• Registration Number: NCT05000593
• Lead Sponsor: Lili Cao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-10
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell treating group	normal saline	Intra-articular injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 1 week for a total of 3 times.
stem cell treating group	Cord Blood Mononuclear Cells (UCB-MNCs)	Intra-articular injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 1 week for a total of 3 times.

Primary Outcome Measures

Name	Time	Method
Lysholm score	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)	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.
American knee society knee score	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)	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.
the knee injury and osteoarthritis score	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)	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.
Visual Analog Score for pain	Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)	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.

Trial Locations

Locations (1)

Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China