Samukawa

Researchers are evaluating the effectiveness and safety of CLS2901C, a human allogenic chondrocyte sheet product, in patients with osteoarthritis of the knee. This phase III study compares outcomes between patients receiving CLS2901C combined with osteotomy plus RMSC and those undergoing osteotomy alone. The study involves patients diagnosed with knee osteoarthritis classified as Kellgren-Lawrence Grade 2 to 4. The investigational treatment, CLS2901C, is made by culturing chondrocytes obtained from cartilage tissue of patients with polydactyly. Patients will be assigned to either receive osteotomy surgery alone or osteotomy plus transplantation of CLS2901C sheets. The evaluation period for each group lasts approximately 14.5 months, including a 52-week assessment phase. After this, participants who continue follow-up will be observed for an additional five years to monitor long-term effects after sheet transplantation. Participants will undergo assessments including the Knee injury and Osteoarthritis Outcome 4 (KOOS 4) score measured at 52 weeks to evaluate efficacy. Researchers will monitor safety through rates of adverse events and device malfunctions. Regular evaluations include imaging and clinical examinations to track cartilage condition and knee function throughout the study and extended follow-up period.

Alopecia areata (AA) is a long-lasting autoimmune condition that causes nonscarring hair loss affecting people of all ages, races, and genders. It mainly impacts the scalp but can also involve nails, eyelashes, eyebrows, and other hair areas on the body. The three main types of AA are patchy alopecia, alopecia totalis, and alopecia universalis. Ritlecitinib is a recently approved medication targeting specific enzymes involved in AA, and this study aims to assess its effectiveness and patient outcomes in a real-world setting. Patients in this study will receive ritlecitinib as prescribed by their doctors according to the approved product label and standard care practices. Treatment will be given in routine clinical practice without influence from the study. The study does not include a comparison group but will monitor how patients are treated with ritlecitinib and their response over time. Participants will have regular clinic visits as part of their standard care, during which data on their disease and treatment will be collected. This includes patient-reported outcomes and questionnaires. The main outcome measured is the percentage change in hair loss severity using the Severity of Alopecia Tool (SALT) score after 24 weeks of treatment. The study will help provide insights into patient characteristics, treatment patterns, and clinical results with ritlecitinib in everyday medical practice.

Researchers are evaluating the effects of hypothermia versus normothermia on patients who have experienced out-of-hospital cardiac arrest and received extracorporeal cardiopulmonary resuscitation (ECPR). This cluster randomized trial, called the SAVE-J NEUROTHERM trial, aims to compare mortality risk, neurological outcomes, and adverse events between these temperature control strategies. The study addresses the ongoing debate about optimal temperature management after cardiac arrest, especially in patients treated with ECPR using extracorporeal membrane oxygenation (ECMO).