Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02624804
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joshua.zenreich@hmhn.org', 'phone': '15519964248', 'title': 'Joshua Zenreich', 'organization': 'Hackensack Meridian Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the initiation of any study procedures to the end of the study treatment follow-up, up to 24 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes\n\nStem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Body Aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection Strep Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes\n\nStem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The primary study endpoint will be the occurrence of treatment-related adverse effects. Adverse events that occur during therapy (especially those that necessitate temporary or permanent discontinuation of therapy) and over the 12-month follow-up period will be assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients Experiencing Treatment Related Adverse Events'}, {'type': 'SECONDARY', 'title': 'Number of Patients Unable to Complete Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes\n\nStem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One week', 'description': 'Number of patients who were unable to complete SCE Therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes\n\nStem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes\n\nStem Cell Educator Therapy: Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-06', 'size': 3409926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-19T13:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-18', 'studyFirstSubmitDate': '2015-12-04', 'resultsFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-18', 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Related Adverse Events', 'timeFrame': '12 months', 'description': 'The primary study endpoint will be the occurrence of treatment-related adverse effects. Adverse events that occur during therapy (especially those that necessitate temporary or permanent discontinuation of therapy) and over the 12-month follow-up period will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Unable to Complete Therapy', 'timeFrame': 'One week', 'description': 'Number of patients who were unable to complete SCE Therapy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes Mellitus Type 1']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single arm, open-label, single-center pilot study to assess the safety, feasibility, and efficacy of Stem Cell Educator therapy for the treatment of patients with Type 1 Diabetes.', 'detailedDescription': 'Our previous work demonstrated that human cord blood-derived multipotent stem cells (CB-SCs) are a unique type of stem cell identified from human cord blood, distinct from other stem cell types including hematopoietic stem cells (HSCs), and mesenchymal stem cells (MSCs). The stem cells and harnessed some of their unique properties with Stem Cell Educator therapy by using CB-SCs in a closed-loop system that circulates a patient\'s blood through a blood cell separator, briefly co-cultures the patient\'s lymphocytes with adherent CB-SCs in vitro, and returns the "educated" lymphocytes (but not the CB-SCs) to the patient\'s circulation . This treatment leads to global immune modulations and immune balance as demonstrated by clinical data and animal studies. The Stem Cell Educator therapy may revolutionize the clinical treatment of diabetes and other immune-related diseases through CB-SCs\' immune education and induction of immune balance, without the safety and ethical concerns associated with conventional stem cell-based approaches'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients \\>/=18 years\n* Must have a diagnosis of type 1 diabetes mellitus based on the 2015 American Diabetes Association criteria for the Clarification and Diagnosis of diabetes\n* Must have a blood test confirming the presence of at least one autoantibody to pancreatic islet cells (IAA, IA2, GAD 65, ZnT8)\n* Fasting C-peptide level \\> 0.3 ng/ml\n* Adequate venous access for apheresis\n* Ability to provide informed consent\n* Must agree to comply with all study requirements and be willing to complete all study visits\n\nExclusion Criteria:\n\n* AST or ALT 2 \\> x upper limit of normal.\n* Creatinine \\> 2.0 mg/dl.\n* Known coronary artery disease or EKG suggestive of coronary artery disease unless cardiac clearance for apheresis is obtained from a cardiologist.\n* Known active infection\n* Pregnancy or breastfeeding mothers\n* Use of immunosuppressive medication within one month of enrollment including but not limited to prednisone, cyclosporine, tacrolimus, sirolimus, and chemotherapy.\n* Presence of any other autoimmune diseases (lupus, rheumatoid arthritis, scleroderma, etc.)\n* Anticoagulation other than ASA.\n* Hemoglobin \\< 10 g/dl or platelets \\< 100 k/ml\n* Is unable or unwilling to provide informed consent\n* Presence of any other physical or psychological medical condition that, in the opinion of the investigator, would preclude participation'}, 'identificationModule': {'nctId': 'NCT02624804', 'briefTitle': 'A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'A Pilot Study of the Therapeutic Potential of Stem Cell Educator Therapy in Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'Pro 6262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cell Educator Therapy', 'description': 'Patients will have apheresis performed and then have their own blood returned to them with the "educated" lymphocytes', 'interventionNames': ['Biological: Stem Cell Educator Therapy']}], 'interventions': [{'name': 'Stem Cell Educator Therapy', 'type': 'BIOLOGICAL', 'otherNames': ['Stem Cell Education'], 'description': 'Patients will receive apheresis and then have their own blood returned to them with the "educated" lymphocytes', 'armGroupLabels': ['Stem Cell Educator Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center - John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}], 'overallOfficials': [{'name': 'Michelle Donato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}