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

NCT05160831 | Unknown

• 1 other identifier: SCforKneeOA
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

knee joint; osteoarthritis; human umbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• VAS score

  Changes of Visual Analogue Scale (VAS) score after injection

  1, 3, 6, 12 months after injection

Secondary Outcomes (1)

• Kellgren-Lawrence score

  1, 3, 6, 12 months after injection

Other Outcomes (4)

• Lequesne Index

  1, 3, 6, 12 months after injection

• WOMAC score

  1, 3, 6, 12 months after injection

• Symptom Grading Scale

  1, 3, 6, 12 months after injection

Study Arms (1)

Human umbilical cord mesenchymal stem cells

EXPERIMENTAL

Human umbilical cord mesenchymal stem cells injection is applied for knee OA patients.

Biological: Human umbilical cord mesenchymal stem cells

Interventions

Human umbilical cord mesenchymal stem cells BIOLOGICAL

Human umbilical cord mesenchymal stem cell injection is applied for treating knee OA patients.

Human umbilical cord mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Liu Yang, MD

  Center for Joint Surgery, Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

• Fuyou Wang, MD

  Center for Joint Surgery, Southwest Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuyou Wang, MD

CONTACT

86-23-68765290; arthro@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Center for Joint Surgery

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 16, 2021
• Study Start: January 20, 2022
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2024
• Last Updated: December 16, 2021

Record last verified: 2021-12