[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510330":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":51,"responsibleParty":74,"collaborators":44,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":44,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":53,"whyStopped":44,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Cohort","EXPERIMENTAL","MSC",[13],"Drug: Mesenchymal stem cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Validation Cohort","PLACEBO_COMPARATOR","Placebo",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Mesenchymal stem cells","Autologous bone marrow derived MSCs",[9],[27],"MSCs",{"type":29,"name":17,"description":30,"armGroupLabels":31,"otherNames":32},"OTHER","Controls",[15],[33],"Control",[35],{"name":36,"affiliation":37,"role":38},"Hongjun N Wang, PhD","Ralph H. Johnson VA Medical Center, Charleston, SC","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Leah Benn","CONTACT","(843) 792-2813",null,"leah.benn@va.gov",{"name":47,"role":42,"phone":48,"phoneExt":49,"email":50},"Alison B Neely","(843) 829-2110","1003","alison.neely@va.gov",[52],{"facility":37,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Charleston","South Carolina","29401-5703","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-79.93275,32.77632,{"lat":63,"lon":62},[66,69,73],{"name":36,"role":42,"phone":67,"phoneExt":44,"email":68},"843-792-1800","hongjun.wang@va.gov",{"name":70,"role":42,"phone":71,"phoneExt":44,"email":72},"Richard A Schatz, MD","(843) 789-7472","Richard.Schatz@va.gov",{"name":36,"role":38,"phone":44,"phoneExt":44,"email":44},{"type":75,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100510330","phase-1-novel-cellular-therapy-for-the-treatment-of-pain-associated-with-chronic-pancreatitis-100510330",false,"NCT05925036","Novel Cellular Therapy for the Treatment of Pain Associated With Chronic Pancreatitis","MSCPainRelief","Inclusion Criteria:\n\n* Age between 18 and 75 years old, male or female\n* Definite chronic pancreatitis M-ANNHEIM criteria (Tsimmerman Ia, 2008) One or more of the following are required:\n* Pancreatic calcifications\n* Moderate or marked ductal lesions\n* Marked and persistent exocrine insufficiency defined as pancreatic steatorrhea markedly reduced by enzyme supplementation\n* Typical histology of an adequate histological specimen\n* Patients who are diagnosed with painful CP for more than 6 months may be constant or may have been waxing and waning\u002Fremitting.\n* Baseline Izbicki pain score \\> 30 (Dworkin et al., 2005)\n* Stable dose of opioids for the past 30 days\n\nExclusion Criteria:\n\n* Acute pancreatitis per 2012 revised Atlanta criteria (23) within the last 30 days oThe revised Atlanta classification requires that two or more of the following criteria be met for the diagnosis of acute pancreatitis: (a) abdominal pain suggestive of pancreatitis, (b) serum amylase or lipase level greater than three times the upper normal value, or (c) characteristic imaging findings.\n* Chronic pain syndromes other than pancreatitis that require daily use of opioids in the past 30 days.\n* Hemoglobin of \\\u003C8.0g\u002FdL, EGFR\\\u003C60 ml\u002Fmin, AST or ALT \\>2 times upper limit of normal, Bilirubin \\> 1.5 mg\u002Fdl unless the subject has confirmed Gilbert syndrome., Platelets \\\u003C100,000\u002Fmicroliter, HbA1c \\>10%\n* Congestive Heart Failure NYHA class \\>1\n* History of Malignancy except for in situ malignancies that have been surgically treated and basal cell skin cancers\n* Evidence of active infection using current antibiotics or with Hepatitis B, C, or HIV\n* Known intravenous contrast allergy causing anaphylaxis\n* Any subject who has had an ongoing alcohol abuse and\u002For illegal drug dependencies within the past six months.\n* Any subject who has received an investigational drug or device within 30 days before randomization or who is expected to receive an investigational drug or device during this study.\n* Patients with planned endoscopic or surgical intervention, surgical resection or needle drainage of pancreatic structures in the next 6 months.\n* Subjects with infected pancreatic pseudocysts or pancreatic walled-off necrotic areas at the time of consent\n* Females who are pregnant or women of childbearing potential (WOCBP) and males with female partners of childbearing potential who are not willing to use adequate contraception during the study\n* Breastfeeding females\n* Subject unwilling to follow the protocol and assessment","ALL","18 Years","75 Years",{"count":87,"type":88},40,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","The goal of this clinical trial is to test whether adult stem cells, called mesenchymal stem cells (MSCs) collected from the patient's bone marrow can help reduce pain caused by chronic pancreatitis and improve pancreatic function.",[94,95],"Chronic Pancreatitis","Chronic Pain",[97,98,99,100,101],"Mesenchymal stem cells (MSCs)","Chronic pancreatitis","Pain relief","Pancreas dysfunction","Fibrosis","2026-04-01",{"date":104,"type":105},"2026-04-07","ACTUAL",{"date":107,"type":105},"2024-01-01",{"date":109,"type":88},"2027-12-31",{"name":5,"class":6},1]