NCT03156257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

May 26, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

May 15, 2017

Last Update Submit

January 14, 2020

Conditions

Cardiovascular Diseases

Keywords

Microgravity Effects on Vascular Cells

Outcome Measures

Primary Outcomes (1)

  • Changes in gene expression in space vs earth cultured vascular 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

Study Arms (1)

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

Interventions

Blood volume collected specifically for this studyBIOLOGICAL

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.

Self-reported healthy males and females

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unwillingness to have blood used in stem cell research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Biospecimen

Retention: NONE RETAINED

Blood

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Josephine Allen, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 17, 2017

Study Start

May 26, 2017

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)