- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028752
A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity (OR-DRPD-SRI2019)
OR-DRPD-SRI2019: A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
While some knowledge has been gained with regards to macrophage alterations during space travel, most of this work has been limited to macrophage cell lines and has not considered how the effects of microgravity alter macrophages' ability to stimulate tissue repair and regeneration. Specifically, how the macrophage secretion profile and/or interaction with endothelial cells is altered during microgravity culture. Given the extensive data showing the consequence of simulated microgravity to alter endothelial cells, and the mounting evidence that simulated microgravity affects macrophage cells, the investigators hypothesize that microgravity alters the functional response of macrophages in close association with endothelial cells. To test this hypothesis, the study team has established 2 specific aims:
Specific Aim 1: Assess the effect of simulated microgravity on endothelial and macrophage pro-healing states.
Specific Aim 2: Assess the effect of simulated microgravity on the pro-healing states of 3-dimensional co-cultured macrophages and endothelial cells.
Completion of the above described aims will lay a strong foundation of knowledge about the impact of simulated microgravity in important cell-cell interactions involved in tissue regeneration and healing
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Self-reported healthy individuals
- Willingness to have 50mls of whole blood collected
Exclusion Criteria:
• Unwillingness to have blood used in microgravity study
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Males and females
The investigators are interested in sampling a wide variety of individuals from varying ethnic groups, sex, and age range.
|
The subject will be sitting in a chair, and a needle will be inserted into a vein in the arm.
Study Team will draw about 45ml or 3 tablespoons of whole blood for research.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isolate macrophages
Time Frame: within 4 hours of blood collection
|
Isolation of circulating immune cells, termed macrophages from whole blood.
The study team will isolate the macrophages that are contained within the peripheral blood mononuclear cell fraction (PBMNC).
The investigators expect to isolate 800,000-3,200,000 PBMNC per ml of blood.
The isolated cells will then be subject to culture in a simulated microgravity device.
|
within 4 hours of blood collection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Josephine Allen, Ph.D., University of Florida
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201902002
- P0132429 (Other Grant/Funding Number: Florida Space Institute)
- OCR25782 (Other Identifier: UF OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Blood collected specifically for this study
-
University of FloridaNational Aeronautics and Space Administration (NASA)CompletedMicrogravity Exposed Endothelial CellsUnited States
-
University of FloridaFlorida Space InstituteCompletedCardiovascular DiseasesUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedAnaphylactic Shock to Neuro-Muscular Blocking Agents (NMBA)France
-
British Columbia Cancer AgencyM.D. Anderson Cancer Center; University of Texas at AustinCompleted
-
Virginia Commonwealth UniversityCompleted
-
Maastricht University Medical CenterUnknown
-
Laval UniversityCanadian Institutes of Health Research (CIHR)UnknownChronic Obstructive Pulmonary DiseaseCanada
-
Inozyme PharmaNot yet recruitingGeneralized Arterial Calcification of Infancy | Autosomal Recessive Hypophosphatemic Rickets | Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency | ATP-Binding Cassette Subfamily C Member 6 Deficiency
-
Istituto Auxologico ItalianoRecruiting