A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients.

The aim of this study was to test the clinical efficacy of TissueGene-C (TG-C), a cell and gene therapeutic for osteoarthritis consisting of non-transformed and transduced chondrocytes (3:1) retrovirally transduced to overexpress transforming growth factor-β1. A total of 163 Kellgren-Lawrence grade 3 patients with knee osteoarthritis were randomly assigned to receive intra-articular TG-C or placebo. Primary efficacy measures included criteria for subjective assessment by International Knee Documentation Committee (IKDC) and pain severity by Visual Analog Scale (VAS) for 52 weeks.

Temporal Patterns and Influential Factors of Blood Glucose Levels During the First 10-Day Critical Period After Brain Injury.

This study was conducted to document temporal patterns of blood glucose level changes during the first 10-day critical period and to identify factors that influence stress-induced hyperglycemia development in brain injury patients. The medical records of 190 brain injury patients were retrospectively reviewed. Blood glucose levels in the poor recovery group were significantly higher than in the good recovery group, particularly during the first 72 hr (158-172 mg/dl).

The Influence of Social Structure on Cancer Pain and Quality of Life.

The aim of this study was to investigate whether social structure is associated with cancer pain and quality of life using the Social Structure and Personality Research Framework. This study was a secondary analysis of data from 480 cancer patients. The measurements included socioeconomic variables, self-reported cancer pain using the McGill Pain Questionnaire-Short Form (MPQ-SF), and quality of life measured using the Functional Assessment of Cancer Therapy Scale (FACT-G).

Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study.

Objective: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima(®), Inflectra(®)]) with two formulations of the reference medicinal product (RMP) (Remicade(®)) from either Europe (EU-RMP) or the USA (US-RMP).

Methods: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013-003173-10). Healthy subjects received single doses (5 mg/kg) of CT-P13 (n = 71), EU-RMP (n = 71) or US-RMP (n = 71).