Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 12:44 AM
Study NCT ID:
NCT04234750
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-09', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing rate', 'timeFrame': '1 month', 'description': 'Original wound area minus unhealed wound area divided by original wound area'}], 'secondaryOutcomes': [{'measure': 'Vancouver score', 'timeFrame': '6 months', 'description': 'Score according to scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites']}, 'descriptionModule': {'briefSummary': 'Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction. In recent years, cytokine therapy has been an important strategy to promote tissue repair.Mesenchymal stem cells (MSC) have been considered the star cells that promote tissue repair. It works mainly through paracrine. Many biological effectors, including IGF-1, vascular endothelial growth factor (VEGF), TGF-β1, and hepatocyte growth factor (HGF), have been found and reported in various MSC conditioned media (MSC-CM), And play a role in promoting tissue repair and regeneration. In here, we aim to explore the MSC-CM-derived pleiotropic factor in treating donor sites and further evaluate its safety and effectiveness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMainly mild to moderate burns, III ° burn area is less than 20% (trauma factor is thermal burn); Thick-thickness skin (thickness 0.2-0.3mm), donor area and medium-thickness skin (thick 0.3-0.5mm) for the skin area study separately; Psychologically stable and able to complete the test process-\n\nExclusion Criteria:\n\nHistory of clotting disorders, uncontrolled diabetes; Drug abuse, excessive drinking, malignant or autoimmune diseases, chemotherapy and immunosuppressive therapy; Significant local infection or combined systemic infection; Patients with severe heart, lung, liver, kidney, blood system and mental and nervous system diseases; Women during pregnancy and lactation-'}, 'identificationModule': {'nctId': 'NCT04234750', 'briefTitle': 'Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'The Evaluation of the Safety and Effectiveness of Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites', 'orgStudyIdInfo': {'id': 'MP-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'mesenchymal stem cell conditioned medium-derived pleiotropic factor', 'interventionNames': ['Biological: mesenchymal stem cell conditioned medium-derived pleiotropic factor']}], 'interventions': [{'name': 'mesenchymal stem cell conditioned medium-derived pleiotropic factor', 'type': 'BIOLOGICAL', 'description': "After the patient is enrolled, when the patient's condition is stable, he is ready to undergo skin transplantation. For the donor site, an electric dermatome was used to remove the skin. The two donor areas of the same patient were divided into a pleiotropic factor group and a blank group randomly. After placing a coarse mesh vaseline oil gauze, then cover a certain thickness of sterile gauze and pressure bandage.", 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Datong', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenlin Fan', 'role': 'CONTACT', 'email': 'fanwenlin@126.com', 'phone': '13835208690'}], 'facility': "People's Liberation Army Central Air Force Hospital", 'geoPoint': {'lat': 40.09361, 'lon': 113.29139}}], 'centralContacts': [{'name': 'Meirong Li, doctor', 'role': 'CONTACT', 'email': 'meirong811225@126.com', 'phone': '010-66936345'}], 'overallOfficials': [{'name': 'Xiaobing Fu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year after clinical trial', 'ipdSharing': 'YES', 'description': "Need to contact the researcher and open sharing after the researcher's consent", 'accessCriteria': 'The way of sharing IPD has not yet been determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Xiaobing Fu', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}