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Completed

NCT Number: NCT03144492

Microgravity Effects on Co-cultured Vascular Cells Types

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.

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Key information

Conditions

Microgravity Exposed Endothelial Cells

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood volume collected specifically for this study

Biological

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.

Primary outcomes

  1. Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells

    Time frame: Within 4 weeks of collecting cells

    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.

Secondary outcomes

  1. Gene and Protein expression of normal vs microgravity cultured stem cells

    Time frame: through study completion, up to 2 years from the start of the study

    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.

  2. Anti-thrombogenic function of normal vs microgravity cultured stem cells

    Time frame: through study completion, up to 2 years from the start of the study

    The study team will utilize platelet adhesion and blood clotting assays to assess any changes in how anti-thrombogenic the differentiated endothelial cells are.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Aeronautics and Space Administration (NASA)

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 8, 2017
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.