[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MedRegen LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100539829","phase-2-mrg-001-as-an-immunoregulatory-and-regenerative-therapy-for-ards-patients-100539829",false,"NCT06308926","MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients","A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome","SUMMIT","Inclusion Criteria:\n\nAcute Respiratory Distress Syndrome, manifested by the following and not explained by alternative diagnoses, for example but not limited to: Pulmonary Edema due to Congestive Heart Failure (CHF).\n\n1. Chest x-ray (CXR)\\* revealing bilateral infiltrates involving a minimum of three quadrants on frontal chest radiograph, consistent with pulmonary edema or bilateral ground glass opacities not fully explained by effusions, lobar or lung collapse, nodules, atelectasis or other etiology of infiltrates not due to ARDS.\n2. PaO2\u002FFiO2 \\\u003C 300.\n3. Requiring respiratory support \\[defined as mechanical ventilation, non-invasive ventilation (NIV) or high flow nasal canula (HFNC)\\] If on ventilator, settings must include positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥5 cm H2O.\n\nExclusion Criteria:\n\n1. Age less than 18 years.\n2. Infiltrates with etiology suspected of mimicking ARDS, ie; Pulmonary Edema due to Congestive Heart Failure (CHF). (A Pulmonary Arterial Wedge Pressure (PAWP) of \\\u003C 18 for \\>12 hours would rule out suspected CHF).\n3. Pregnancy documented or suspected in women of child bearing potential, unless ruled out by a negative pregnancy test during screening or breast feeding.\n4. Immunocompromised patients:\n\n   4.1. Organ or bone marrow transplant recipients and\u002For recent (within 2 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1\u002F2 inhibitors, interferons, interleukins, (prednisone or related corticosteroids are allowed).\n\n   4.2. Patients with documented or suspected HIV\u002FAIDS, hepatitis B\u002FC or active lung disease with tuberculosis. 4.3. Patients with active cancer diagnosis or use of chemotherapy in the past 3 months.\n5. Hypersensitivity to either of the components of MRG-001.\n6. The patient is known or suspected to be brain dead or is moribund (not expected to live \\>48 hours) or is unlikely to survive long enough to receive 3 injections (4 days) in the opinion of the investigator.\n7. The primary care physician is not committed to full support of the patient. (A DNR representing \"no chest compression\" only, would not necessarily be an exclusion. A DNR in which life support is withheld\u002Fwithdrawn or is otherwise limited, would be an exclusion).\n8. Participation in another investigational protocol or use of another investigational drug within 30 days of enrollment.\n9. Enrollment time window has been exceeded (must be enrolled within 7 days of hospital admission and within 48 hours of development of ARDS).\n10. Significant pre-existing organ dysfunction prior to randomization:\n\n    10.1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record. 10.2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg. WHO Class III or IV pulmonary hypertension. 10.3. Renal: End-stage renal disease requiring renal replacement therapy or eGFR \\\u003C30 mL\u002Fmin. 10.4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or pre-existing severe hepatic dysfunction (i.e.; portal hypertension, cirrhosis, ascites, esophageal variceal bleeding, acute hepatic necrosis). 10.5. Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL. 10.6. Neurological: Severe traumatic brain injury, with intracranial injury demonstrated by head CT 10.7. History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n11. Currently receiving extracorporeal life support (ECLS\u002FECMO) or high-frequency oscillatory ventilation (HFOV).\n12. Anticipated extubation within 24 hours of enrollment.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS.\n\nThe aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.",[27,28,29,30,31],"Acute Respiratory Distress Syndrome","Respiratory Failure","Respiratory Distress Syndrome","Respiratory Tract Diseases","Cytokine Storm",[27,33,34,35],"MRG-001","Stem Cells","Immunomodulation","NOT_YET_RECRUITING","2024-08-22",{"date":39,"type":40},"2024-08-23","ACTUAL",{"date":42,"type":21},"2024-12-01",{"date":44,"type":21},"2026-07-01",{"name":46,"class":47},"MedRegen LLC","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100540343","phase-2-mrg-001-in-patients-with-amyotrophic-lateral-sclerosis-100540343","NCT06315608","MRG-001 in Patients With Amyotrophic Lateral Sclerosis","An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Able to provide written informed consent (either from patient or patient's legally acceptable representative and complying with study procedures, in the PI's opinion.\n* Male or female patients between 18-75 years.\n* Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.\n* Time since onset of weakness due to ALS ≤ 48 months at the time of the Screening Visit\n* Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the Screening Visit measured by Slow Vital Capacity (SVC), or Forced Vital Capacity (FVC).\n* Patients must either not take Riluzole or be on a stable dose of Riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study.\n* Participants must either not take Edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study.\n* Participants must either not take Relyvrio (AMX0035) or be on a stable dose of Relyvrio for ≥ 30 days prior to the Master Protocol Screening Visit. Relyvrio-naïve participants are permitted in the study.\n* Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrhoeic for at least 12 months) must utilize appropriate birth control throughout the study duration.\n* Male patients must agree to use a medically acceptable method of contraception \u002Fbirth control throughout the study duration.\n\nExclusion Criteria:\n\n* Subjects who meet one or more of the following criteria will not be considered eligible to participate in the clinical study:\n* Participation in another interventional clinical trial (drug or device) within 30 days of Screening and at any time during the study.\n* Significant pre-existing organ dysfunction prior to randomization:\n* Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.\n* Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg.\n* Renal: End-stage renal disease requiring renal replacement therapy or creatinine clearance \\\u003C50 mL\u002Fmin.\n* Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL.\n* Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.\n* History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n* Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.\n* Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational) including tofersen (Qalsody).\n* History of splenectomy or splenomegaly (spleen weighing \\>750 g).\n* Co-infection with human immunodeficiency virus (HIV).\n* History of organ or bone marrow transplantation, other than a corneal transplant.\n\nor recent (within 3 months) chronic use of immunosuppressive drugs (tacrolimus, mycofenolate mofetil, cyclosporine, rapamycine, hydrochloroquine, azathiopurine, methotrexate), e.g., biologicals, JAK1\u002F2 inhibitors, interferons, interleukins or (prednisone or related corticosteroids are allowed).\n\n* Hypersensitivity to either of the components of MRG-001.\n* If female, known pregnancy, or has a positive serum pregnancy test, or lactating\u002Fbreastfeeding.\n* Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.","75 Years",{"count":57,"type":21},10,[24],"The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months.",[61,62,63,64],"Amyotrophic Lateral Sclerosis","Lou Gehrig Disease","Motor Neuron Disease","Motor Neuron Atrophy",[33,34,66,67],"Regulatory T-cells","Fixed-Dose Combination",{"date":39,"type":40},{"date":70,"type":21},"2025-07-01",{"date":72,"type":21},"2026-03-01",{"name":46,"class":47},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100539721","phase-2-mrg-001-in-patients-with-alcoholic-hepatitis-100539721","NCT06307522","MRG-001 in Patients With Alcoholic Hepatitis","An Open-Label, Dose-Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Alcoholic Hepatitis","Inclusion Criteria:\n\n1. Informed Consent: Able to provide written informed consent, either personally or through a legally acceptable representative.\n2. Male or female patients 21 years of age or older.\n3. Onset of jaundice within the prior 8 weeks.\n4. Alcohol Consumption: Average daily consumption of more than 40 grams for females or more than 60 grams for males of alcohol for 6 months or longer, with less than 8 weeks of abstinence before the onset of jaundice.\n5. Diagnostic Criteria for AH: AH may be diagnosed based on typical serum chemistry or liver biopsy during the current episode of AH, including:\n\n   * Serum bilirubin \\> 3 mg\u002FdL\n   * AST between 50 and 400 IU\u002FL\n   * ALT \\\u003C 400 IU\u002FL\n   * AST\u002FALT ratio \\> 1.5\n6. Maddrey Discriminant Function (MDF): MDF ≥ 32, assuming a control prothrombin time of 12 seconds.\n7. Model for End-stage Liver Disease (MELD) Score: MELD score between 21 and 30.\n8. Liver Biopsy (Optional): Liver biopsy is not required but may be used to confirm the diagnosis of AH at the Investigator's discretion. If used, the biopsy must have occurred during the current episode.\n9. Contraception for Women: Women of childbearing potential must use appropriate birth control throughout the study duration. Contraception for Men: Male patients must agree to use a medically acceptable method of contraception or birth control throughout the study duration.\n\nExclusion Criteria:\n\n1. Informed Consent: Inability to provide written informed consent, either personally or through a legally acceptable representative.\n2. Participation in Other Clinical Trials: Participation in another interventional clinical trial (drug or device) within 30 days of screening and at any time during the study.\n3. Concomitant Liver Diseases: Presence of other concomitant causes of liver disease, such as viral hepatitis, autoimmune liver disease, metabolic liver disease, or vascular liver disease.\n4. Liver Biopsy Incompatibility: Liver biopsy findings, if conducted, not compatible with alcoholic hepatitis (AH).\n5. Absence of Active Infection: No evidence of active infection as determined by the investigator, with specific criteria outlined for diagnosing and treating infections.\n6. Uncontrolled Gastrointestinal Bleeding: Presence of uncontrolled gastrointestinal bleeding.\n7. History of pre-admission refractory ascites, as defined by the frequency of paracenteses despite diuretic therapy.\n8. Significant pre-existing organ dysfunction in various systems, including lung, heart, kidney, hematologic, neurological, and spleen-related conditions.\n\n   1. Lung: Receiving supplemental home oxygen therapy at baseline for pre-existing medical condition (other than COVID-19), as documented in medical record.\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record. Clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction (past 3 months), heart and coronary vessel surgery (past 3 months), significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure \\>180 mm Hg and diastolic blood pressure \\>110 mm Hg.\n   3. Renal: End-stage renal disease requiring renal replacement therapy or creatintine clearance \\\u003C30 mL\u002Fmin.\n   4. Hematologic: Baseline platelet count \\\u003C30,000\u002Fmm3 or hemoglobin levels \\\u003C6.0 g\u002FdL.\n   5. Neurological: Stage ≥3 hepatic encephalopathy by West Haven criteria.\n   6. History of splenectomy or splenomegaly (spleen weighing \\> 750 g).\n9. Presence of any active malignancy or malignancy diagnosed within the last five years, excluding curable skin cancer.\n10. Patients requiring the use of vasopressors or inotropic support, excluding stabilized conditions within the first 7 days of hospital admission.\n11. Presence of co-infection with human immunodeficiency virus (HIV) or active tuberculosis on chest X-ray at study entry.\n12. History of organ or bone marrow transplantation, excluding corneal transplant, or recent chronic use of immunosuppressive drugs.\n13. Positive urine drug screen for specific substances, excluding THC and prescription medications.\n14. Hypersensitivity to either of the components of MRG-001.\n15. If female, known pregnancy, positive serum pregnancy test, or lactating\u002Fbreastfeeding.\n16. Underlying diseases that might be complicated or exacerbated by proposed treatments or confound assessment of study drug, as determined by the site investigator.","21 Years",{"count":83,"type":21},32,[24],"The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis (AH).",[87,88],"Alcoholic Hepatitis","Acute Alcoholic Hepatitis",[33,34,35,87,90,91,92],"Hepatitis, Alcoholic","Infection","Liver Diseases, Alcoholic","2024-03-05",{"date":95,"type":40},"2024-03-13",{"date":97,"type":21},"2024-09-01",{"date":99,"type":21},"2026-12-01",{"name":46,"class":47},""]