Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT04996966
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2021-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D055370', 'term': 'Lung Injury'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013898', 'term': 'Thoracic Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-17', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oxygenation index', 'timeFrame': 'Before the operation, 6 hours, 3days, and 7days after the MSCs injection', 'description': 'The change in oxygenation index after the operation'}], 'secondaryOutcomes': [{'measure': 'The value of arterial blood cLAC', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in arterial blood cLAC after the operation'}, {'measure': 'The content of IL-1β', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood IL-1β after the operation'}, {'measure': 'The content of IL-6', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood IL-6 after the operation'}, {'measure': 'The content of TGF-α', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood TGF-α after the operation'}, {'measure': 'The content of HMGB1', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood HMGB1 after the operation'}, {'measure': 'The content of IL-10', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood IL-10 after the operation'}, {'measure': 'The content of B-type natriuretic peptide (BNP)', 'timeFrame': 'Before the operation and 7days after the MSCs injection', 'description': 'The change in venous blood B-type natriuretic peptide after the operation'}, {'measure': 'electrocardiogram', 'timeFrame': 'Before the operation, 7days, and 28 days after the MSCs injection', 'description': 'The change in electrocardiogram after the operation'}, {'measure': 'The average length of stay in hospital', 'timeFrame': 'The average length of stay in hospital', 'description': 'The change in the length of stay in hospital between the two groups'}, {'measure': 'The visual analog scale（VAS）score', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The change in VAS score after the operation，the minimum value is 0 and the maximum value is 10, the higher scores mean a worse outcome.'}, {'measure': 'The hospital for special surgery (HSS) Knee Score', 'timeFrame': 'Before the operation, 7days, and 28 days after the MSCs injection', 'description': 'The change in HSS Knee Score after the operation, the minimum value is 0 and the maximum value is 100, the higher scores mean a better outcome.'}, {'measure': 'The New York Heart Association (NYHA) Functional Classification', 'timeFrame': 'Before the operation, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The change in NYHA Functional Classification after the operation, the lowest level is Class I and the highest level is Class IV, the higher level mean a worse outcome.'}, {'measure': 'The 36-Item Short Form Survey (SF-36)', 'timeFrame': 'Before the operation and 28 days after the MSCs injection', 'description': 'The change in SF-36 after the operation, the minimum value is 40 and the maximum value is 850, the higher scores mean a better outcome.'}, {'measure': 'The Hamilton Anxiety Scale', 'timeFrame': 'Before the operation, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The change in degree of anxiety after the operation, the minimum value is 0 and the maximum value is 56, the higher scores mean a worse outcome.'}, {'measure': 'The incidence of allergic reaction', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The allergic reaction after the MSCs injection'}, {'measure': 'The body temperature', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The body temperature before and after the operation'}, {'measure': 'The pulse rate', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The pulse rate before and after the operation'}, {'measure': 'The respiration rate', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The respiration rate before and after the operation'}, {'measure': 'The blood pressure', 'timeFrame': 'Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection', 'description': 'The blood pressure before and after the operation'}, {'measure': 'The content of C-reactive protein (CRP)', 'timeFrame': 'Before the operation and 7 days after the MSCs injection', 'description': 'The change in venous blood CRP after the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['human umbilical cord-derived mesenchymal stem cells', 'lung injury'], 'conditions': ['Ischemic Heart Disease', 'Lung Injury', 'Non-cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.', 'detailedDescription': 'This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease.\n\nThe study is a randomized parallel controlled study. The research process is as follows: 1. Sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or hUC-MSCs treatment group (n=8); 2. Knee replacement was performed under general anesthesia in both groups. In the cell therapy group, 1×10\\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery. Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection, all patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The electrocardiogram showed T wave change and ST segment depression\n* New York Heart Association (NYHA) Classification of cardiac function Ⅰ-Ⅱ level\n* The patient who first time to receive knee replacement\n* General anesthesia lasted about 2h\n* Signed informed consent\n\nExclusion Criteria:\n\n* Does not meet the above selection criteria\n* Unable to sign the informed consent\n* Patients with a malignant tumor, other serious systemic diseases, or psychosis\n* Pregnancy, lactation, and those who are not pregnant but do not take effective contraceptives measures\n* The patient with a history of an allergic reaction to biological products or drug\n* The patient has any infectious diseases (including bacterial and viral infections)\n* The patient with cardiac pacemaker implantation within 3 months prior to enrollment\n* The patient who had a stroke within 6 months prior to enrollment\n* Unable to comply with the agreed timetable of this study\n* Patients who are participating in other clinical trials\n* Others who are clinically considered unsuitable for this treatment.'}, 'identificationModule': {'nctId': 'NCT04996966', 'briefTitle': 'Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease', 'orgStudyIdInfo': {'id': 'DFDA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.', 'interventionNames': ['Other: saline']}, {'type': 'EXPERIMENTAL', 'label': 'MSCs injection', 'description': 'In the MSCs injection group, 1×10\\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.', 'interventionNames': ['Biological: human umbilical cord-derived mesenchymal stem cells']}], 'interventions': [{'name': 'human umbilical cord-derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'In the MSCs injection group, 1×10\\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.', 'armGroupLabels': ['MSCs injection']}, {'name': 'saline', 'type': 'OTHER', 'description': 'In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongmin Liu', 'role': 'CONTACT', 'email': 'liu.zhongmin@tongji.edu.cn', 'phone': '+86-021-38804518'}], 'facility': 'Shanghai East Hospital, Shanghai Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiangrui Wang', 'role': 'CONTACT', 'email': 'xiangruiwang@vip.sina.com', 'phone': '+86-021-38804518-22198'}, {'name': 'Lijun Liao', 'role': 'CONTACT', 'phone': '+86-021-38804518-22198'}], 'overallOfficials': [{'name': 'Xiangrui Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}