Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03156257
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2017-05-15
Brief Title:
The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
OR-DRPD-SRICASIS2016 The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OR-DRPD-SRI
Brief Summary:
By studying the affect of the space environment on vascular cell types our goal is to elucidate the mechanism of vascular cell damage in the space environment by exposing vascular cells to space flight In this pilot study The study team propose to assess changes in transcriptomics of vascular cell types in space compared to those in a ground based study
Detailed Description:
Under conditions of simulated microgravity it is well known that normal cellular processes of vascular cells are altered While these studies provide important information about these alterations in cells it is likely not a complete picture due to the limitations of ground based simulated microgravity It is our hypothesis that real microgravity as is experienced in space will reveal changes in EC and SMC phenotype and function that alters cell-cell communication The study team will test our hypothesis by culturing mature endothelial cells as well as stem cell derived endothelial cells and mature smooth muscle cells in low Earth orbit LEO on the International Space Station ISS US National Laboratory The specific aims the Study team have proposed are the following
Specific Aim 1 Preflight isolation and characterization of circulating stem cell derived endothelial cells Specifically the Study team will isolate CSCs from whole blood then direct them down an EC pathway Once differentiated the study team will characterize their phenotype
Specific Aim 2 Culture mature ECs SMCs and CSC derived ECs under conditions of low Earth orbit LEO aboard the ISS Specifically The study team will use advanced flight hardware to establish an active cell culture on the ISS The cells will be cultured for a duration of 3 and 10 days at which time the cells will be frozen for subsequent analysis Simultaneously the study team will culture the same populations in a ground based microgravity simulator as well as a normal gravity control
Specific Aim 3 Assess the morphologic and genetic changes in cells after 3 and 10 days of space flight Specifically upon return to Earth a transcriptome analysis will be completed from the frozen cell samples to assess changes in the cells molecular machinery
This proposed study builds upon the abundant literature including our own surrounding the effects of ground based simulated microgravity on vascular endothelial cells However the study team include the less studied populations of smooth muscle cells and stem cell derived ECs The goal of this work is to leverage conditions on the ISS a powerful one-of-a-kind microgravity research platform in low Earth orbit to study these cells and their cellular processes as it relates to cardiovascular disease CVD and cardiovascular deconditioning This work seeks to reveal currently unknown changes in vascular cell health that lead to these diseases The impact of this work is broad and can lead to new treatment options for millions of people who suffer from CVD including neointimal hyperplasia
Specific Aim 1 Preflight isolation and characterization of circulating stem cell derived endothelial cells Specifically the Study team will isolate CSCs from whole blood then direct them down an EC pathway Once differentiated the study team will characterize their phenotype
Specific Aim 2 Culture mature ECs SMCs and CSC derived ECs under conditions of low Earth orbit LEO aboard the ISS Specifically The study team will use advanced flight hardware to establish an active cell culture on the ISS The cells will be cultured for a duration of 3 and 10 days at which time the cells will be frozen for subsequent analysis Simultaneously the study team will culture the same populations in a ground based microgravity simulator as well as a normal gravity control
Specific Aim 3 Assess the morphologic and genetic changes in cells after 3 and 10 days of space flight Specifically upon return to Earth a transcriptome analysis will be completed from the frozen cell samples to assess changes in the cells molecular machinery
This proposed study builds upon the abundant literature including our own surrounding the effects of ground based simulated microgravity on vascular endothelial cells However the study team include the less studied populations of smooth muscle cells and stem cell derived ECs The goal of this work is to leverage conditions on the ISS a powerful one-of-a-kind microgravity research platform in low Earth orbit to study these cells and their cellular processes as it relates to cardiovascular disease CVD and cardiovascular deconditioning This work seeks to reveal currently unknown changes in vascular cell health that lead to these diseases The impact of this work is broad and can lead to new treatment options for millions of people who suffer from CVD including neointimal hyperplasia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P0036354 | OTHER_GRANT | Florida Space Institute | None |