Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis

NCT06716281 | Recruiting Phase 3

• 1 other identifier: LC-MSCOA23001
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis. To evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• WOMAC total score

  The change in WOMAC total score from baseline at 48 weeks post-dose.

  48 week

• cartilage damage

  The change in cartilage damage area from baseline at 48 weeks post-dose.

  48 week

Study Arms (2)

MSC group

EXPERIMENTAL

IxCell hUC-MSC-O;2.5×10\^7 cells/1 mL, 1 mL/vial; 2ml

Biological: Human umbilical cord mesenchymal stem cells

placebo group

PLACEBO COMPARATOR

Sodium Chloride Injection；1 mL/vial；2ml

Biological: Placebo

Interventions

Human umbilical cord mesenchymal stem cells BIOLOGICAL

a single intra-articular injection of IxCell hUC-MSC-O at a dose of 5.0×10\^7 cells with a volume of 2.0 mL

MSC group

Placebo BIOLOGICAL

Sodium Chloride Injection

placebo group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with knee osteoarthritis according to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association;
• Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal anti-inflammatory drugs, viscosupplementary therapy, etc.;
• The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;
• Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;
• Patients with a VAS pain score of ≥50mm (total score of 100mm) in the study side knee joint at the time of screening;
• Ages between 40 and 80, with no gender restrictions. BMI (Body Mass Index, weight \[kg\]/height\^2 \[m\^2\]) ≤30;
• Able to understand and voluntarily sign the informed consent form, and willing to complete the trial procedures and follow-up examinations.

You may not qualify if:

• Patients diagnosed with secondary knee osteoarthritis;
• Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis, symptomatic chondrocalcinosis, osteonecrosis, or active infections, lower limb arteriosclerosis obliterans, etc.);
• Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;
• Patients who have previously used stem cell therapy;
• Patients who have received opioid, non-steroidal anti-inflammatory analgesics, or any other pain-relieving medication for knee osteoarthritis within 2 weeks or 7 half-lives (whichever is longer) before treatment;
• Patients who have received physiotherapy or traditional Chinese medicine treatment for knee arthritis (either side) within 6 weeks before treatment;
• Patients who have received local injection of glucocorticoids, anesthetics, or local application of glucocorticoids for the knee joint (either side) within 12 weeks before treatment, or who have received systemic glucocorticoid treatment within 12 weeks, or who require systemic glucocorticoid treatment during the study;
• Patients who started taking glucosamine, chondroitin sulfate, or diacerein within 4 weeks before treatment (except those who have been taking glucosamine or chondroitin sulfate for a long time and have continued to take them for 4 weeks before treatment and are willing to maintain the dosage and frequency during the study);
• Patients who have received any drug injection treatment in the knee joint cavity (either side) within 6 months before treatment;
• Patients who have undergone major surgery, arthroplasty, or arthroscopy on the study side knee joint within 24 weeks before signing the informed consent form, or those who plan to undergo surgical treatment on the study side knee joint during the study;
• Patients who have undergone surgical treatment on the lower limbs (hip or knee) within 12 weeks before signing the informed consent form;
• Patients whose study side knee joint is not suitable for MRI examination, such as those with metal implants affected by magnetic fields;
• Patients who plan to undergo any type of lower limb surgery within 48 weeks after signing the informed consent form;
• Patients with skin diseases or skin infections around the intended injection site;
• Patients with osteoarthritis on the opposite side of the study knee joint and who plan to undergo intra-articular drug therapy during the study;

Sponsors & Collaborators

• Shanghai IxCell Biotechnology Co., LTD: lead

Study Sites (1)

The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jie Zhao

  The Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhao

CONTACT

86-21-23271699; 13301815365@189.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: January 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CN (1)