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

NCT ID: NCT05000593

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

normal saline

Intervention Type OTHER

Intra-articular injection of normal saline

Cord Blood Mononuclear Cells (UCB-MNCs)

Intervention Type OTHER

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

Interventions

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normal saline

Intra-articular injection of normal saline

Intervention Type OTHER

Cord Blood Mononuclear Cells (UCB-MNCs)

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lili Cao

OTHER

Sponsor Role lead

Responsible Party

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Lili Cao

dean of orthopeadic department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Qianfoshan Hospital

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 23744977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26474054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29196647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24462672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27510262 (View on PubMed)

Other Identifiers

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YXLL-KY-2020(040)

Identifier Type: -

Identifier Source: org_study_id

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