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.

Study Overview

• Status: Completed
• Conditions: Microgravity Exposed Endothelial Cells
• Intervention / Treatment: Biological: Blood volume collected specifically for this study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
self-reported healthy individuals; Self-reported healthy individuals avoiding blood draw on the days participants are feeling "under the weather"or sick. In that case, study team can delay the blood draw until the subject feels better, but this would not preclude anyone from participating.	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

Outcome Measure	Measure Description	Time Frame
Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem 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.	Within 4 weeks of collecting cells

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene and Protein expression of normal vs microgravity cultured stem cells	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.	through study completion, up to 2 years from the start of the study
Anti-thrombogenic function of normal vs microgravity cultured stem cells	The study team will utilize platelet adhesion and blood clotting assays to assess any changes in how anti-thrombogenic the differentiated endothelial cells are.	through study completion, up to 2 years from the start of the study

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Aeronautics and Space Administration (NASA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2017
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (ACTUAL): May 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cell Culture; Microgravity co-culture
• Other Study ID Numbers: IRB201700297; 16-2016GL_FP-0011 (OTHER_GRANT: National Aeronautics and Space Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No