Microgravity Effects on Co-cultured Vascular Cells Types

Microgravity Exposed Endothelial Cells Clinical Trial

Official title:

Microgravity Effects on Co-cultured Vascular Cells Types

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144492
• Other study ID #: IRB201700297
• Secondary ID: 16-2016GL_FP-001
• Status: Completed
• Start date: May 26, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Microgravity Exposed Endothelial Cells

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Aeronautics and Space Administration (NASA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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