NCT04893174

Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA).

A Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety and Tolerability After Intra Articular (IA) Injection of UMC119-06-05 in Adult Subjects With Mild to Moderate Knee Osteoarthritis(KOA).

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Meridigen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The clinical study with UMC119-06-05 is designed to investigate the safety in patients with mild to moderate knee osteoarthritis (KOA). This will be a dose escalation, open label, single-center study in adult with mild to moderate knee osteoarthritis. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of knee osteoarthritis.

Detailed description

Knee osteoarthritis (KOA), also known as degenerative joint disease, is the most common type of arthritis diagnosed. KOA is typically the result of wear and tear and progressive loss of articular cartilage. The prevalence of the Knee osteoarthritis will continue to increase as life expectancy and obesity rises. Osteoarthritis is typically a progressive disease that may eventually lead to disability. The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time.The intensity of the clinical symptoms may vary from each individual. However, they typically become more severe, more frequent, and more debilitating over time. The rate of progression also varies for each individual. Common clinical symptoms include knee pain that is gradual in onset and worse with activity, knee stiffness and swelling, pain after prolonged sitting or resting, and pain that worsens over time. Treatment for knee osteoarthritis begins with conservative methods and progresses to surgical treatment options when conservative treatment fails. While medications can help slow the progression of RA and other inflammatory conditions, no proven disease-modifying agents for the treatment of knee osteoarthritis currently exist. Among the more innovative, experimental therapies, mesenchymal stromal cells (MSCs) are proposed as a novel therapy with potential in treatment of KOA.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	UMC119-06-05	Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid. Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05
DEVICE	Hyaluronic acid	IA injection of hyaluronic acid.

Timeline

• Start date: 2022-09-15
• Primary completion: 2024-09-01
• Completion: 2025-06-01
• First posted: 2021-05-19
• Last updated: 2023-12-04

Locations

1 site across 1 country: Taiwan