NCT06082440

Study on the Safety and Tolerance of Mesenchymal Stem Cells Mediated by Arthroscopy in Patients With Osteoarthritis

A Single-Arm Clinical Study on the Safety and Tolerance of Human Umbilical Cord Mesenchymal Stem Cells Mediated by Arthroscopy in Patients With Stage II-III Knee Osteoarthritis

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis. This experiment proposes to enroll 18-22 patients. The experimental drug is human umbilical cord mesenchymal stem cells.

Detailed description

This study adopts a design for a single-dose increasing, single-center, randomized, placebo-controlled trial to explore the safety, tolerance and preliminary efficacy of the single-dose administration of human umbilical cord mesenchymal stem cells mediated by arthroscopy in patients with knee osteoarthritis, as well as to provide a basis for the subsequent clinical study of drug delivery plans. The experimental process of this study is divided into four stages: screening period, baseline period, study treatment and safety observation period, follow-up period.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	Human Umbilical Mesenchymal Stem Cells	Ntra-articular injection inject a corresponding dose of cells suspension into each joint cavity according to the lesion site.

Timeline

• Start date: 2023-11-22
• Primary completion: 2025-08-15
• Completion: 2026-01-10
• First posted: 2023-10-13
• Last updated: 2024-01-05

Locations

1 site across 1 country: China