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

November 3, 2022 updated by: Lili Cao
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 252000
        • Qianfoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: normal saline
Intra-articular injection of normal saline
Other: Cord Blood Mononuclear Cells (UCB-MNCs)
Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm score
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lili Cao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2020(040)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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