Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Umbilical Cord Mesenchymal Stem Cells 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: NCT05160831
Recruitment Status : Not yet recruiting
First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Liu Yang, MD, Southwest Hospital, China

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Human umbilical cord mesenchymal stem cells Not Applicable

Detailed Description:

There are more than 100 types of arthritis, and the most common ones are rheumatoid arthritis (RA) and osteoarthritis (OA). The main cause of its pathogenesis is the compensatory hyperplasia of the articular cartilage caused by the body's degenerative changes, which will eventually cause the joint to partially or completely lose its function.

In the past few decades, continuous efforts have been made to treat OA. The treatment of OA changes with the development of the patient's condition. At present, there are many diagnosis and treatment options for knee OA, including conservative treatment and surgical treatment. There is an urgent need for an effective treatment to postpone or terminate the course of OA.

Cell therapy for OA has developed rapidly in recent years and has received widespread attention. Mesenchymal stem cells (MSCs) are pluripotent stem cells with potential of self-renewal, proliferation and differentiation. Stem cells are extracted from the patient's body and then implanted back. Their ability of regeneration and reproduction can fill the damaged cartilage tissue, so as to achieve an effective treatment of the joint damage.

This study aims to investigate the effectiveness and safety of human umbilical cord mesenchymal stem cell injection in the articular cavity to treat moderate to severe knee osteoarthritis (OA), and whether it can achieve articular cartilage regeneration, reduction of joint pain, and restoration of joint function.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
Estimated Study Start Date : January 20, 2022
Estimated Primary Completion Date : January 20, 2023
Estimated Study Completion Date : January 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Human umbilical cord mesenchymal stem cells
Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients.
 Biological: Human umbilical cord mesenchymal stem cells
Human umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. VAS score [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of Visual Analogue Scale (VAS) score after injection


Secondary Outcome Measures :
  1. Kellgren-Lawrence score [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of Kellgren-Lawrence Score


Other Outcome Measures:
  1. Lequesne Index [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of the Lequesne Index

  2. WOMAC score [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

  3. Symptom Grading Scale [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of Symptom Grading Scale

  4. SF-12 [ Time Frame: 1, 3, 6, 12 months after injection ]
    Changes of the 12-Item Short Form Survey (SF-12)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have no major organ dysfunction.
  • Diagnosed as moderate to severe knee osteoarthritis according to internationally recognized criteria: a). Meets the criteria of the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" revised by the Chinese Medical Association Rheumatology Branch in 2018; b). Meets the criteria of Grade 3 or more according to the American College of Rheumatology (ACR); c).Meets the criteria of Grade Ⅲ or more according to Kellgren-Lawrence's OA radiology grading standard.
  • Those who have the ability to move independently, except those who use wheelchairs, walkers or crutches, and who have no history of mental illness.
  • There is no obvious contraindication to articular cavity injection in hematology and biochemical testing.
  • No local or systemic infection.
  • Subjects and their families understand the clinical trial protocol and agree to participate in the trial, and sign a written Informed Consent.
  • Patients whose pain has lasted for more than half a year, and the routine clinical treatment of oral hormones, opioids and other drugs have been ineffective.

Exclusion Criteria:

  • Those who are older than 70 years old or younger than 18 years old, or have no full capacity for civil conduct.
  • HIV, hepatitis virus or syphilis virus infection or positive serological test.
  • Body mass index (BMI) greater than 30 kg/m2.
  • Congenital or acquired knee deformity; severe knee arthritis accompanied by severe varus deformity, with varus greater than 10°.
  • Pregnant or lactating women, or women of childbearing age who have a positive pregnancy test within 7 days before receiving treatment.
  • Complicated with severe cardiovascular and cerebrovascular, liver, kidney, and endocrine, blood system diseases, malignant tumors, allergies, mental disorders, acute infections or local knee joint infections.
  • Patients with immunodeficiency.
  • Patients with a history of intra-articular injection within 3 months; patients being treated with immunosuppressive agents and glucocorticoids.
  • Patients who are still participating in other clinical trials.
  • Subjects who refuse to sign Informed Consent or refuse to participate in this clinical trial.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05160831


Contacts
Layout table for location contacts
Contact: Fuyou Wang, MD 86-23-68765290 arthro@126.com

Sponsors and Collaborators
Southwest Hospital, China
Investigators
Layout table for investigator information
Principal Investigator: Liu Yang, MD Center for Joint Surgery, Southwest Hospital, China
Principal Investigator: Fuyou Wang, MD Center for Joint Surgery, Southwest Hospital, China
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Liu Yang, MD, Professor of Center for Joint Surgery, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT05160831    
Other Study ID Numbers: SCforKneeOA
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liu Yang, MD, Southwest Hospital, China:
knee joint
osteoarthritis
human umbilical cord mesenchymal stem cells
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases