search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
normal saline
Cord Blood Mononuclear Cells (UCB-MNCs)
Sponsored by
Lili Cao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Cord Blood Mononuclear Cells, Knee Osteoarthritis

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qianfoshan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cell treating group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
November 3, 2022
Sponsor
Lili Cao
search

1. Study Identification

Unique Protocol Identification Number
NCT05000593
Brief Title
Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Official Title
Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lili Cao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Cord Blood Mononuclear Cells, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stem cell treating group
Arm Type
Experimental
Arm Description
Intra-articular injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 1 week for a total of 3 times.
Intervention Type
Other
Intervention Name(s)
normal saline
Intervention Description
Intra-articular injection of normal saline
Intervention Type
Other
Intervention Name(s)
Cord Blood Mononuclear Cells (UCB-MNCs)
Intervention Description
Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)
Primary Outcome Measure Information:
Title
Lysholm score
Description
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.
Time Frame
Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Title
American knee society knee score
Description
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.
Time Frame
Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Title
the knee injury and osteoarthritis score
Description
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.
Time Frame
Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)
Title
Visual Analog Score for pain
Description
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.
Time Frame
Compare the changes of 1 month, 3 months, 6 months and one year before treatment (baseline) and after (third injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Qianfoshan Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
252000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23744977
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.
Results Reference
background
PubMed Identifier
26474054
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.
Results Reference
background
PubMed Identifier
29196647
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.
Results Reference
background
PubMed Identifier
24462672
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.
Results Reference
background
PubMed Identifier
27510262
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs