Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06242405
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2024-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Child A', 'timeFrame': '24 weeks', 'description': 'Patients with Child A'}], 'secondaryOutcomes': [{'measure': 'Change in liver function parameters', 'timeFrame': '24 weeks', 'description': 'Values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh'}, {'measure': 'Incidence of hepatic decompensation events', 'timeFrame': '24 weeks', 'description': 'Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy'}, {'measure': 'Survival rate and liver transplant rate', 'timeFrame': '24 weeks', 'description': 'Number of patients surviving and undergoing liver transplantation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cirrhosis', 'end-stage liver diseases', 'umbilical cord-mesenchymal stem cells', 'randomized controlled trial'], 'conditions': ['End-Stage Liver DIsease']}, 'referencesModule': {'references': [{'pmid': '25154380', 'type': 'BACKGROUND', 'citation': 'Volarevic V, Nurkovic J, Arsenijevic N, Stojkovic M. Concise review: Therapeutic potential of mesenchymal stem cells for the treatment of acute liver failure and cirrhosis. Stem Cells. 2014 Nov;32(11):2818-23. doi: 10.1002/stem.1818.'}, {'pmid': '38179765', 'type': 'BACKGROUND', 'citation': 'Wang J, Li Q, Li W, Mendez-Sanchez N, Liu X, Qi X. Stem Cell Therapy for Liver Diseases: Current Perspectives. Front Biosci (Landmark Ed). 2023 Dec 28;28(12):359. doi: 10.31083/j.fbl2812359.'}]}, 'descriptionModule': {'briefSummary': 'Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.', 'detailedDescription': 'Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. 18-80 years old\n* 2\\. End-stage liver disease\n* 3\\. Signed informed consent\n\nExclusion Criteria:\n\n* 1\\. Tumours of the liver or other organs\n* 2\\. Liver transplantation recipients\n* 3\\. Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases\n* 4\\. Other diseases that may seriously affect the survival\n* 5\\. Human immunodeficiency syndrome\n* 6\\. Interferon or glucocorticoid therapy within 1 year\n* 7\\. Treated for mental illness\n* 8\\. Participation in other clinical trials within 30 days\n* 9\\. Pregnant or breastfeeding subjects\n* 10\\. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies\n* 11\\. Other circumstances that are unsuitable for participation in this study'}, 'identificationModule': {'nctId': 'NCT06242405', 'briefTitle': 'Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with ESLD', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients with End-stage Liver Disease', 'orgStudyIdInfo': {'id': 'XHNKKY-DFSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-infusion group', 'description': 'Single peripheral venous infusion of stem cells', 'interventionNames': ['Biological: umbilical cord-mesenchymal stem cells']}, {'type': 'EXPERIMENTAL', 'label': 'Double-infusion group', 'description': 'Repeated peripheral venous infusion of stem cells within one month', 'interventionNames': ['Biological: umbilical cord-mesenchymal stem cells']}], 'interventions': [{'name': 'umbilical cord-mesenchymal stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['UC-MSCs'], 'description': 'Umbilical cord mesenchymal stem cells injected through peripheral veins', 'armGroupLabels': ['Double-infusion group', 'Single-infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110840', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingshun Qi, MD', 'role': 'CONTACT', 'email': 'xingshunqi@126.com', 'phone': '18909881019'}, {'name': 'Wen Ning, MM', 'role': 'CONTACT', 'email': '13390132472@163.com', 'phone': '13390132472'}], 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Xingshun Qi, MD', 'role': 'CONTACT', 'email': 'xingshunqi@126.com', 'phone': '18909881019'}, {'name': 'Wen Ning, MM', 'role': 'CONTACT', 'email': '13390132472@163.com', 'phone': '13390132472'}], 'overallOfficials': [{'name': 'Xingshun Qi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The General Hospital of Northern Theater Command'}, {'name': 'Wen Ning, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The General Hospital of Northern Theater Command'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of Gastroenterology', 'investigatorFullName': 'Xingshun Qi', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}