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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
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
IA injection of hyaluronic acid.
Taipei Medical University Hospital
Taipei, Taiwan
RECRUITINGThe incidence and frequency of adverse events related to administration of UMC119-06-05.
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).
Time frame: 1 months from the day of administration
Changes of total score in the Western Ontario and McMaster (WOMAC) assessment on the target knee.
Improvement in total score (pain subscale, and stiffness subscale, and physical function subscale) as assessed by mean change in WOMAC index.
Time frame: from baseline up to 52 weeks after administration
Changes of arthritis pain on target knee using the 100-mm visual-analogue scale (VAS).
VAS scale range 0 to 100 mm, with higher scores indicates greater pain intensity. A decrease in score represents a decrease in disease related pain of knee.
Time frame: from baseline up to 52 weeks after administration
Whole Organ Magnetic Resonance Imaging Score (WORMS).
Changes on the target knee for knee cartilage and the joint soft tissues assessed by Whole Organ Magnetic Resonance Imaging Score (WORMS) using magnetic resonance imaging (MRI) of T2 mapping.
Time frame: from baseline up to 52 weeks after administration
Changes in Kellgren-Lawrence (K-L) grading and joint space on target knee.
The severity of knee OA was defined as kellgren-lawrence (K-L) classification criteria. Changes from baseline to post-treatment visits on the target knee for Kellgren-Lawrence (K-L) grading and joint space in X-ray examination results.
Time frame: from baseline up to 52 weeks after administration
Amount of rescue medications required.
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Total amount of acetaminophen or non-steroidal anti-inflammatory drugs (NSAID)
Time frame: at first 4 weeks, first 28 weeks and the whole study period.