Microgravity Effects on Co-cultured Vascular Cells Types

Completed

• Conditions: Microgravity Exposed Endothelial Cells
• Interventions: Biological: Blood volume collected specifically for this study

• Registration Number: NCT03144492
• Lead Sponsor: University of Florida

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Study Start: 2017-05-26
• Status Verified: 2020-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

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Exclusion Criteria

• Unwillingness to have blood used in stem cell research

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
self-reported healthy individuals	Blood volume collected specifically for this study	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.

Primary Outcome Measures

Name	Time	Method
Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells	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 Outcome Measures

Name	Time	Method
Gene and Protein expression of normal vs microgravity cultured stem cells	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.
Anti-thrombogenic function of normal vs microgravity cultured stem cells	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States