Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Knee Osteoarthritis

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 Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Human umbilical cord mesenchymal stem cells

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuyou Wang, MD; Phone Number: 86-23-68765290; Email: arthro@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Changes of Visual Analogue Scale (VAS) score after injection	1, 3, 6, 12 months after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kellgren-Lawrence score	Changes of Kellgren-Lawrence Score	1, 3, 6, 12 months after injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lequesne Index	Changes of the Lequesne Index	1, 3, 6, 12 months after injection
WOMAC score	Changes of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index	1, 3, 6, 12 months after injection
Symptom Grading Scale	Changes of Symptom Grading Scale	1, 3, 6, 12 months after injection
SF-12	Changes of the 12-Item Short Form Survey (SF-12)	1, 3, 6, 12 months after injection

Collaborators and Investigators

• Sponsor: Southwest Hospital, China
• Investigators: Principal Investigator: Liu Yang, MD, Center for Joint Surgery, Southwest Hospital, China; Principal Investigator: Fuyou Wang, MD, Center for Joint Surgery, Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2022
• Primary Completion (Anticipated): January 20, 2023
• Study Completion (Anticipated): January 20, 2024

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; human umbilical cord mesenchymal stem cells; knee joint
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: SCforKneeOA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No