A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity (OR-DRPD-SRI2019)

NCT04028752 | Withdrawn

• 3 other identifiers: IRB201902002P0132429OCR25782
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposal contained herein seeks to examine the effect of simulated microgravity on important cell-cell interactions that govern vascular health. The interest lies in endothelial cell (EC) and macrophage cell interactions. The investigators are proposing to first understand how microgravity effects the macrophage and EC function or pro-healing capabilities. Next, the study team plans to develop a 3D tissue regeneration model in which macrophages and ECs are co-cultured in a hydrogel matrix. Utilizing this model, the team will assess how microgravity influenced macrophage-EC interactions in 3D. The investigators will assess EC tubule volume (or blood vessel development), macrophage spreading and the interactions with endothelial tubule sprouts. This model will serve as a critical foundation for future grant opportunities as it allows the assessment of tissue regeneration and vascular health in a 3D tissue microenvironment

Conditions

Cardiovascular Diseases

Keywords

macrophage; microgravity; blood; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Isolate macrophages

  Isolation of circulating immune cells, termed macrophages from whole blood. The study team will isolate the macrophages that are contained within the peripheral blood mononuclear cell fraction (PBMNC). The investigators expect to isolate 800,000-3,200,000 PBMNC per ml of blood. The isolated cells will then be subject to culture in a simulated microgravity device.

  within 4 hours of blood collection

Study Arms (1)

Males and females

The investigators are interested in sampling a wide variety of individuals from varying ethnic groups, sex, and age range.

Biological: Blood collected specifically for this study

Interventions

Blood collected specifically for this study BIOLOGICAL

The subject will be sitting in a chair, and a needle will be inserted into a vein in the arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.

Males and females

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

General population between 21-50 years old.

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 microgravity study

Sponsors & Collaborators

• University of Florida: lead
• Florida Space Institute: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Josephine Allen, Ph.D.

  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: July 19, 2019
• First Posted: July 23, 2019
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share