NCT06716281

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Shanghai IxCell Biotechnology Co., LTD · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mesenchymal stem cells (MSCs), as a kind of cells with multiple differentiation potential, have gradually shown their advantages in the treatment of osteoarthritis (OA) cartilage lesions. MSCs exist widely in connective tissues and interstitial organs of the whole body, such as bone marrow, umbilical cord, fat, etc., and can become specialized cells to perform functions under specific signal stimulation. MSCs can also secrete a variety of enzymes and nutritional factors such as growth factors, cytokines, chemokines, etc. to participate in the paracrine process, and play anti-apoptosis, anti-fibrosis, anti-oxidation, anti-inflammatory and pro-angiogenesis roles. In vitro studies and a number of clinical studies have confirmed that direct injection of MSCs into the joint cavity has a certain therapeutic effect on OA.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Human umbilical cord mesenchymal stem cells	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
BIOLOGICAL	Placebo	Sodium Chloride Injection

Timeline

• Start date: 2024-01-05
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-04
• Last updated: 2024-12-06

Locations

1 site across 1 country: China