Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-02 @ 12:37 AM
Study NCT ID:
NCT02883803
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Severe Infections With Mesenchymal Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOFA score', 'timeFrame': 'Day 7 (or death day or day of recovery unit exit if before day 7)', 'description': 'To assess the efficacy of a recovery treatment'}], 'secondaryOutcomes': [{'measure': 'Number of living days without catecholamines', 'timeFrame': 'Day 28'}, {'measure': 'Number of living days without mechanical ventilation', 'timeFrame': 'Day 28'}, {'measure': 'Number of living days without dialysis', 'timeFrame': 'Day 28'}, {'measure': 'Duration of residence time in recovery unit', 'timeFrame': 'Day of exit from recovery unit, up to 90 days'}, {'measure': 'Mortality, across all causes', 'timeFrame': 'Day 28'}, {'measure': 'Mortality, across all causes', 'timeFrame': 'Day 90'}, {'measure': 'Administration safety (i.e. side effects)', 'timeFrame': 'up to 90 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.', 'detailedDescription': 'Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line or 250 ml albumin 4% alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine \\> 8μg/kg/min)\n* At least 2 organ failure other than hemodynamic\n* Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)\n* Signature of informed consent (patient/close relative or reliable person)\n* Affiliation to social security plan\n\nExclusion Criteria:\n\n* Non-septic shock\n* Nosocomial septic shock\n* PaO2/FiO2 \\<100\n* Pregnant or breast-feeding woman\n* Brain death\n* Dying person\n* Therapeutic limitations\n* Participation to another current interventional clinical trial or since less than 30 days'}, 'identificationModule': {'nctId': 'NCT02883803', 'acronym': 'CHOCMSC', 'briefTitle': 'Treatment of Severe Infections With Mesenchymal Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study', 'orgStudyIdInfo': {'id': 'PHRCI 2012/CHOCMSC-GIBOT/SKJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC', 'description': 'Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line.', 'interventionNames': ['Biological: Injection of mesenchymal stem cells']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 250 ml albumin 4%, infused for 30 minutes in central venous line.', 'interventionNames': ['Biological: Injection of albumin alone']}], 'interventions': [{'name': 'Injection of mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Injection of mesenchymal stem cells', 'armGroupLabels': ['MSC']}, {'name': 'Injection of albumin alone', 'type': 'BIOLOGICAL', 'description': 'Injection of albumin alone', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Pierre-Emmanuel Charles', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Réanimation Médicale, Hôpital Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Sébastien GIBOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Réanimation Médicale, Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpital Hautepierre, Service de réanimation médicale', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'contacts': [{'name': 'Danièle Bensoussan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Véronique Decot', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UTCT, Hôpital Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Sébastien GIBOT', 'role': 'CONTACT', 'email': 's.gibot@chu-nancy.fr', 'phone': '+33383852970'}, {'name': 'Daniele BENSOUSSAN', 'role': 'CONTACT', 'email': 'd.bensoussan@chru-nancy.fr', 'phone': '+33383153779'}], 'overallOfficials': [{'name': 'Sébastien GIBOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}