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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04893174
Study type	Interventional
Source	Meridigen Biotech Co., Ltd.
Contact	Claire Liao, MS
Phone	+886-2-8978-7777
Email	claire.liao@meridigen.com
Status	Recruiting
Phase	Phase 1
Start date	September 15, 2022
Completion date	June 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.