Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT03123458
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-08
First Post:
2017-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2017-03-13', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': 'up to one month', 'description': 'Safety of cfMSC infusion acute and prolonged'}], 'secondaryOutcomes': [{'measure': 'Number of participants with reduced symptoms or stabilized conditions after treatment', 'timeFrame': 'after 1 month from fMSC infusion', 'description': 'Short term clinical effects measured by physiological and serological parameters related to the disease condition and symptoms using prepared study assessment table.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSC', 'GVHDs', 'transplantation'], 'conditions': ['Immune Related Disorder', 'Tissue Damage']}, 'descriptionModule': {'briefSummary': 'The primary objectives are to evaluate the safety and efficacy of infusion of the third party fully-characterized clonally derived fetal MSCs (cfMSCs) for the control of severe symptoms associated with acute and chronic immune-related disorders and tissue damage.', 'detailedDescription': 'MSCs have been extensively studied and clinically evaluated for the treatment of autoimmune diseases and graft versus host disease (GVHD) after hematopoietic stem cell transplantation (HSCT). The variable source of MSCs and the lack of consistency of primary tissue-derived MSCs are major obstacles to reliable translational applications of such therapeutic cell products. Fetal tissue-derived clonal MSCs (cfMSCs) have extended expansion potential and express rich levels of various growth factors, and thus can achieve quality consistency. Careful evaluation of fMSCs in clinical studies has not been conducted. Autoimmune diseases involve aberrant immune responses that harm tissues and organs. GVHD is a serious and often fatal problem associated with HSCT. MSCs have immunomodulatory and immunosuppressive effects. In many studies, MSCs have demonstrated promising beneficial effects that reduce severe autoimmune reactions, diminish symptoms of chronic GvHD and therapy-resistant acute GvHD including steroid-resistant GVHD. The safety and therapeutic effects of phenotype and functionally characterized fMSCs still require extensive clinical evaluation. This study aims to assess the safety and the potential beneficial effects of infusion of various dosages of third party fMSCs for the control of severe symptoms associated with acute and chronic immune-related disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent.\n2. No available alternative treatment that can reduce the symptoms\n3. Patients are required to meet the following inclusion criteria:\n\n * Any patient that has clinically documented abnormal immune or age-related disorders including acute and chronic GVHD. Patients may receive best available treatment for the control of disease symptoms.\n * Patients with symptoms associated with genetic defects or infectious diseases are not eligible.\n\nExclusion Criteria:\n\n1. Inability to give informed consent.\n2. Patients with ongoing infection or history of cancer.\n3. Patients with poor clinical conditions with the life expectancy of less than 14 days.\n4. Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03123458', 'briefTitle': 'Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Geno-Immune Medical Institute'}, 'officialTitle': 'Clonal Fetal Mesenchymal Stem Cells (cfMSCs) for the Control of Immune-related Disorders', 'orgStudyIdInfo': {'id': 'GIMI-IRB-17001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm, cfMSC to treat immune disorders', 'description': 'cfMSCs treatment', 'interventionNames': ['Biological: clonal fetal MSCs']}], 'interventions': [{'name': 'clonal fetal MSCs', 'type': 'BIOLOGICAL', 'description': 'clonal fetal MSCs', 'armGroupLabels': ['Single arm, cfMSC to treat immune disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Capital Institute of Pediatrics affiliated Children's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shenzhen Geno-immune Medical Institute', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '100049', 'city': 'Beijing', 'country': 'China', 'facility': 'Aerospace Center Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Geno-Immune Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Lung-Ji Chang', 'investigatorAffiliation': 'Shenzhen Geno-Immune Medical Institute'}}}}