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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05000593
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Lili Cao, Qianfoshan Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: normal saline Other: Cord Blood Mononuclear Cells (UCB-MNCs) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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

Sham Comparator: control group
Intra-articular injection of normal saline was performed once every 1 week for a total of 3 times.
Other: normal saline
Intra-articular injection of normal saline




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000593


Contacts
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Contact: Xinfeng Yan +86 13869112527 13869112527@163.com

Locations
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China, Shandong
Qianfoshan Hospital Recruiting
Jinan, Shandong, China, 252000
Contact: Lili Cao       qykyc309@163.com   
Principal Investigator: Xinfeng Yan         
Sponsors and Collaborators
Lili Cao
Publications:
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Responsible Party: Lili Cao, dean of orthopeadic department, Qianfoshan Hospital
ClinicalTrials.gov Identifier: NCT05000593    
Other Study ID Numbers: YXLL-KY-2020(040)
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lili Cao, Qianfoshan Hospital:
Cord Blood Mononuclear Cells
Knee Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases