Asan Si

This clinical trial is a phase III study evaluating the effectiveness and safety of Cellgram-LC, an autologous mesenchymal stem cell treatment, in patients with alcoholic liver cirrhosis. The trial aims to assess the treatment's benefits over a period of 60 months after a single dose. Participants have alcoholic cirrhosis diagnosed through alcohol history, imaging, pathology, and clinical symptoms, and belong to Child-Pugh grade B or C with a score of 7 or more. Participants will receive a single injection of Cellgram-LC through the hepatic artery using catheterization. The treatment is delivered once, and the study monitors the long-term effects and safety over five years. This open-label, randomized trial is conducted across multiple centers to gather data on the treatment's impact on patients with this liver condition. During the study, participants will undergo regular assessments for transplant-free survival over three years, safety monitoring, and other clinical evaluations as per protocol. Researchers will evaluate liver function, disease progression, and any adverse effects throughout the follow-up period. The total participant involvement includes screening, treatment, and extended observation to comprehensively understand the treatment's efficacy and safety.

Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.

Researchers are evaluating whether the 2-year chance of major adverse cardiac events differs between two methods of guiding Percutaneous Coronary Intervention (PCI) in patients with Left Main Coronary Artery disease. The study compares Fractional Flow Reserve (FFR)-guided PCI to angiography-guided PCI to better understand treatment decision-making for this heart condition. Participants will be divided into two groups receiving either FFR-guided PCI or angiography-guided PCI. Both are procedures used to treat significant narrowing in the left main coronary artery. The study involves monitoring each participant's health and event occurrences over a two-year period. Throughout the study, all participants will be closely monitored until their last scheduled visit, which may occur up to two years after treatment. Researchers will check for any major cardiac events during this time to assess differences between the two treatment approaches. The primary measure is the combined rate of these events over the two years.

This research aims to evaluate the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who were previously treated in the PMC-P-07 study. The study focuses on monitoring these patients over a period of 60 months after receiving a single dose of Cellgram-LC. The main goal is to assess how safe this treatment is for this specific condition over an extended timeframe. Participants in this study have already been administered Cellgram-LC during the PMC-P-07 trial. This follow-up study involves no new treatments but observes these patients to gather safety data. The focus is on a long-term observation period of 5 years to track any adverse events or complications that may arise after the initial treatment. During the 5-year follow-up, researchers will monitor the rate of adverse events of special interest and the occurrence of liver transplants. Participants will be regularly assessed to ensure their health status is carefully tracked. This extended monitoring helps to better understand the long-term effects and safety profile of Cellgram-LC in patients with alcoholic liver cirrhosis.

Researchers are examining how different target levels of low-density lipoprotein (LDL) cholesterol affect patients who have had a small vessel occlusion (SVO) stroke, a type of ischemic stroke. The study addresses a gap in current stroke guidelines, which do not clearly define optimal LDL-cholesterol targets for different stroke types, especially for SVO stroke where hypertension is a major risk factor but high LDL-cholesterol may also contribute. This trial aims to improve secondary prevention by comparing intensive versus standard lipid-lowering therapies in adults with confirmed SVO stroke within 180 days of starting the study. Participants will be randomly assigned to one of two groups: an intensive treatment group targeting LDL-cholesterol levels under 70 mg/dL, or a standard treatment group targeting LDL levels between 90 and 110 mg/dL. Treatments include statins with or without ezetimibe, and if necessary, PCSK9 inhibitors to help achieve these LDL-cholesterol goals. The study plans to enroll 4,016 participants from multiple centers and will follow them for at least four years to monitor cardiovascular health outcomes. During the study, participants will have their LDL-cholesterol levels regularly checked and receive lipid-lowering therapies adjusted as needed to meet their target. Researchers will monitor major adverse cardiovascular events such as cardiovascular death, stroke recurrence, and acute coronary syndrome over the follow-up period. Participants must consent to the study and be available for long-term follow-up, which will provide important data to guide optimal cholesterol management for SVO stroke patients.

Researchers are studying patients with walled-off pancreatic necrosis (WON), a serious condition that can develop after acute pancreatitis and is linked to a high risk of death. The study compares two approaches to treating WON: the standard endoscopic step-up approach and direct endoscopic necrosectomy (DEN) performed at the time of stent placement. Recent evidence suggests DEN might lead to faster resolution and fewer procedures, but this trial aims to confirm these findings by evaluating clinical outcomes. Participants undergo endoscopic drainage using lumen-apposing metal stents (LAMS). They are randomly assigned to receive either the step-up approach, where necrosectomy is performed after drainage if needed, or the direct approach, where necrosectomy is done immediately during stent placement. Necrosectomy involves removing dead pancreatic tissue using a gastroscope and specialized instruments. This international multicenter trial plans to enroll 108 patients over about three years. During the study, researchers will monitor for major complications or death within six months after randomization as the main outcome. They will also evaluate time to WON resolution, pancreatic function, need and number of necrosectomies, hospital and ICU stays, recurrence rates, and unplanned readmissions related to WON. Imaging, clinical assessments, and patient histories will be used to track progress and safety throughout the study period.