The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes (OR-DRPD-SRI)

January 14, 2020 updated by: University of Florida

OR-DRPD-SRI/CASIS2016: The Role of the Space Environment on Vascular Endothelial and Smooth Muscle Cell Processes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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) U.S. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Study team is interested in sampling a wide variety of health individuals from varying ethnic groups, sex, and age range.

Description

Inclusion Criteria:

  • Self-reported healthy individuals
  • Willingness to have 50mls of whole blood collected

Exclusion Criteria:

  • Unwillingness to have blood used in stem cell research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Self-reported healthy males and females
The investigators are interested in sampling a wide variety of individuals from varying ethnic groups, sex, and age range.
Biological: Blood volume collected specifically for this study
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in gene expression in space vs earth cultured vascular cells
Time Frame: within 1 year of collecting cells
Post space flight the study team will conduct transcriptomics analysis to assess changes in the cells grown in space (microgravity), on earth (normal gravity), and in a rotating wall vessel bioreactor (ground based simulated microgravity)
within 1 year of collecting cells

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Florida Space Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201700080
  • P0036354 (Other Grant/Funding Number: Florida Space Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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