Samukawa

Researchers are evaluating the effectiveness and safety of CLS2901C human allogenic chondrocyte sheets combined with proximal tibial osteotomy compared to osteotomy alone in patients with osteoarthritis of the knee OAK. This phase III study focuses on patients aged 20 to 79 years diagnosed with OAK, classified by specific X-ray criteria. The purpose is to understand how this new cellular therapy may impact knee function and symptoms over time. The study involves two groups one receiving osteotomy surgery alone and the other receiving osteotomy combined with CLS2901C chondrocyte sheets applied to the knee. The chondrocyte sheets are made by culturing cartilage cells derived from patients with polydactyly. The evaluation period for each group lasts about 14.5 months, including 52 weeks of active assessment followed by up to 5 years of additional observation for those available to continue. Participants will undergo various assessments including knee function measured by the KOOS 4 score over 52 weeks. Safety is monitored through adverse event rates and product malfunctions. Researchers will also continue to observe patients for up to 5 years after receiving the chondrocyte sheets to evaluate long-term effects. The overall study duration spans from initial treatment through extended follow-up to fully understand treatment outcomes and safety.

Alopecia areata AA is a chronic autoimmune condition causing hair loss on the scalp and other body areas, affecting children, adolescents, and adults of all backgrounds. This study focuses on patients aged 12 years and older who are prescribed ritlecitinib, a medication approved for severe AA. Researchers aim to understand patient and disease characteristics, treatment patterns, and outcomes with ritlecitinib in everyday clinical practice. Participants receive ritlecitinib according to approved guidelines and their doctors judgment, reflecting real-world treatment rather than a controlled trial setting. The study observes patients over time, assessing how the medication is used and its impact on AA symptoms. No placebo or control group is involved, as the study is observational. Throughout the study, patients attend regular clinic visits to monitor their condition, complete questionnaires about their experience and quality of life, and undergo assessments like the Severity of Alopecia Tool SALT score. The main measurement is the percentage change in SALT score after 24 weeks, with additional follow-ups at later weeks to evaluate ongoing effectiveness and patient satisfaction. The total study period extends to April 2028.

This research investigates the effects of hypothermia versus normothermia on patients who have undergone extracorporeal cardiopulmonary resuscitation ECPR following out-of-hospital cardiac arrest OHCA. The trial aims to compare mortality risks, neurological outcomes, and adverse events between these two temperature management strategies. The study addresses uncertainties regarding the best temperature control after ECPR, which is a resuscitation method using ECMO to support heart and lung function during cardiac arrest. Participants receive either hypothermia treatment, where their body temperature is cooled to 33-34C using ECMO with a heat exchanger, or normothermia treatment, where the temperature is maintained at 36C. After reaching the target temperature, it is maintained for 24 hours, followed by a 24-hour rewarming period to 36-37.5C, which is then sustained until ECMO ends or for 24 hours post-rewarming. Additional treatments like sedation, muscle relaxants, antipyretics, and circulatory support may be used as needed. During the trial, participants are closely monitored for survival at discharge about 25 days, neurological function using cerebral performance categories, and adverse events during their intensive care stay approximately two weeks. Follow-up assessments occur at 30 days, 90 days, and one year after admission. The study tracks these outcomes to evaluate which temperature management approach might better support recovery after ECPR in OHCA patients.

Researchers are evaluating the efficacy and safety of deuruxolitinib in Japanese adults aged 18 to 65 years with severe alopecia areata, characterized by 50% or greater scalp hair loss. The study includes a double-blind, randomized, placebo-controlled treatment period followed by an open-label extension, focusing on hair regrowth and patient satisfaction. Participants will be randomly assigned to receive either deuruxolitinib 8 mg orally twice daily or a matching placebo for 24 weeks. After this period, all participants will receive deuruxolitinib 8 mg twice daily during a 52-week open-label extension. The study compares the effects of the active drug against placebo initially, then monitors all participants on the active treatment. Throughout the study, participants will be assessed using the Severity of Alopecia Tool SALT score to measure hair loss, along with patient-reported outcomes on hair satisfaction and quality. Clinical evaluations include changes in eyebrow and eyelash appearance, anxiety and depression scales, and other related measures. Safety and treatment response will be monitored over the entire 76-week participation period.