Microgravity Effects on Co-cultured Vascular Cells Types

NCT03144492 | Completed

• 2 other identifiers: IRB20170029716-2016GL_FP-0011
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Microgravity Exposed Endothelial Cells

Keywords

Cell Culture; Microgravity co-culture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gene and Protein expression of normal vs microgravity cultured stem cells

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

• Anti-thrombogenic function of normal vs microgravity cultured stem cells

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

Study Arms (1)

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

Interventions

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.

self-reported healthy individuals

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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

Sponsors & Collaborators

• University of Florida: lead
• National Aeronautics and Space Administration (NASA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

stem cell acquisition and differentiation

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 2, 2017
• First Posted: May 8, 2017
• Study Start: May 26, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)