Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-26 @ 8:26 AM
Study NCT ID:
NCT03144492
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microgravity Effects on Co-cultured Vascular Cells Types
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stem cell acquisition and differentiation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells', 'timeFrame': 'Within 4 weeks of collecting cells', 'description': 'The study team are interesting in the effect of co-cultured Endothelial cells on the kinetics of stem cell colony formation (i.e. differentiation). As compared to normal gravity samples, the colonies that form while in co-culture with ECs will be counted and monitored. This gives a measure of the differentiation potential of these cells.'}], 'secondaryOutcomes': [{'measure': 'Gene and Protein expression of normal vs microgravity cultured stem cells', 'timeFrame': 'through study completion, up to 2 years from the start of the study', 'description': 'The study team will use rtPCR to probe the stem cells for the up regulation of Endothelial cell (EC) specific genes and down regulation of stem cell genes. EC specific genes include vascular endothelial cadherin (CD144), platelet endothelial cell adhesion molecule (PECAM), and von Willebrand factor (vWF). Stem cell markers include CD34. The study team will use GAPDH as a control.'}, {'measure': 'Anti-thrombogenic function of normal vs microgravity cultured stem cells', 'timeFrame': 'through study completion, up to 2 years from the start of the study', 'description': 'The study team will utilize platelet adhesion and blood clotting assays to assess any changes in how anti-thrombogenic the differentiated endothelial cells are.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cell Culture', 'Microgravity co-culture'], 'conditions': ['Microgravity Exposed Endothelial Cells']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the affect of ground based microgravity on co-cultured vascular cell types. Our goal is to better understand the cross-talk between vascular cell types grown under conditions such as microgravity as is seen in space. In this pilot study, the investigator proposes to assess changes in cell phenotype and function in microgravity as compared to normal gravity.', 'detailedDescription': 'This study builds upon previously reported space flight data in GenLab, as well as our own published data whereby the investigator evaluate the effect of microgravity on the differentiation and functional potential of circulating stem cells. The goal of this work is to leverage the powerful genetic analyses done in the SPHINX study and look at the consequences these changes have on cell-cell communications essential for vascular homeostasis, for a possible correlation to cardiovascular deconditioning. The application of this work is targeted at possible "cell based" countermeasures to address the negative effects of microgravity on the vasculature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Study team is interested in sampling a wide variety of health individuals from varying ethnic groups, sex, and age range.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported healthy individuals\n* Willingness to have 50mls of whole blood collected\n\nExclusion Criteria:\n\n* Unwillingness to have blood used in stem cell research'}, 'identificationModule': {'nctId': 'NCT03144492', 'briefTitle': 'Microgravity Effects on Co-cultured Vascular Cells Types', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Microgravity Effects on Co-cultured Vascular Cells Types', 'orgStudyIdInfo': {'id': 'IRB201700297'}, 'secondaryIdInfos': [{'id': '16-2016GL_FP-0011', 'type': 'OTHER_GRANT', 'domain': 'National Aeronautics and Space Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'self-reported healthy individuals', 'description': 'Self-reported healthy individuals avoiding blood draw on the days participants are feeling "under the weather"or sick. In that case, study team can delay the blood draw until the subject feels better, but this would not preclude anyone from participating.', 'interventionNames': ['Biological: Blood volume collected specifically for this study']}], 'interventions': [{'name': 'Blood volume collected specifically for this study', 'type': 'BIOLOGICAL', 'description': 'The subject will be sitting in a chair, and a needle will be inserted into a vein in their arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.', 'armGroupLabels': ['self-reported healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Josephine Allen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Aeronautics and Space Administration (NASA)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}