Back to resultsHuman Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Human umbilical cord mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee joint, osteoarthritis, human umbilical cord mesenchymal stem cells
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Human umbilical cord mesenchymal stem cells
Arm Description
Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients.
Outcomes
Primary Outcome Measures
VAS score
Changes of Visual Analogue Scale (VAS) score after injection
Secondary Outcome Measures
Kellgren-Lawrence score
Changes of Kellgren-Lawrence Score
Full Information
NCT ID
NCT05160831
First Posted
December 6, 2021
Last Updated
December 6, 2021
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05160831
Brief Title
Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
Official Title
Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 20, 2022 (Anticipated)
Primary Completion Date
January 20, 2023 (Anticipated)
Study Completion Date
January 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee joint, osteoarthritis, human umbilical cord mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Human umbilical cord mesenchymal stem cells
Arm Type
Experimental
Arm Description
Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients.
Intervention Type
Biological
Intervention Name(s)
Human umbilical cord mesenchymal stem cells
Intervention Description
Human umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients.
Primary Outcome Measure Information:
Title
VAS score
Description
Changes of Visual Analogue Scale (VAS) score after injection
Time Frame
1, 3, 6, 12 months after injection
Secondary Outcome Measure Information:
Title
Kellgren-Lawrence score
Description
Changes of Kellgren-Lawrence Score
Time Frame
1, 3, 6, 12 months after injection
Other Pre-specified Outcome Measures:
Title
Lequesne Index
Description
Changes of the Lequesne Index
Time Frame
1, 3, 6, 12 months after injection
Title
WOMAC score
Description
Changes of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time Frame
1, 3, 6, 12 months after injection
Title
Symptom Grading Scale
Description
Changes of Symptom Grading Scale
Time Frame
1, 3, 6, 12 months after injection
Title
SF-12
Description
Changes of the 12-Item Short Form Survey (SF-12)
Time Frame
1, 3, 6, 12 months after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuyou Wang, MD
Phone
86-23-68765290
Email
arthro@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Yang, MD
Organizational Affiliation
Center for Joint Surgery, Southwest Hospital, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fuyou Wang, MD
Organizational Affiliation
Center for Joint Surgery, Southwest Hospital, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis
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