Cardiovascular DiseasesNCT04028752
A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity (OR-DRPD-SRI2019)
An observational study of Cardiovascular Diseases, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Blood collected specifically for this study
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: General population between 21-50 years old.
Who may be able to join
- Self-reported healthy individuals
- Willingness to have 50mls of whole blood collected
Who cannot join
- Unwillingness to have blood used in microgravity study
About this study
Official title: OR-DRPD-SRI2019: A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity
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
Read the detailed description
While some knowledge has been gained with regards to macrophage alterations during space travel, most of this work has been limited to macrophage cell lines and has not considered how the effects of microgravity alter macrophages' ability to stimulate tissue repair and regeneration. Specifically, how the macrophage secretion profile and/or interaction with endothelial cells is altered during microgravity culture. Given the extensive data showing the consequence of simulated microgravity to alter endothelial cells, and the mounting evidence that simulated microgravity affects macrophage cells, the investigators hypothesize that microgravity alters the functional response of macrophages in close association with endothelial cells. To test this hypothesis, the study team has established 2 specific aims:
Specific Aim 1: Assess the effect of simulated microgravity on endothelial and macrophage pro-healing states.
Specific Aim 2: Assess the effect of simulated microgravity on the pro-healing states of 3-dimensional co-cultured macrophages and endothelial cells.
Completion of the above described aims will lay a strong foundation of knowledge about the impact of simulated microgravity in important cell-cell interactions involved in tissue regeneration and healing
- Conditions
- Cardiovascular Diseases
- Being tested
- Blood collected specifically for this study
- Keywords
- macrophage, microgravity, blood, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collected specifically for this studyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Males and females | The investigators are interested in sampling a wide variety of individuals from varying ethnic groups, sex, and age range. Receives: Biological: Blood collected specifically for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 4 hours of blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study startJun 2021 (estimated)
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: Grant ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Space Institute
- Responsible party
- Sponsor
- Investigators
- Josephine Allen, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028752
- Sponsor's protocol ID
- IRB201902002
- Other IDs
- P0132429, OCR25782
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data obtained will be disseminated through publications and conference presentations. No subject data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OR-DRPD-SRI2019: A 3D Hydrogel Model to Assess Endothelial Cell-macrophage Interactions in Simulated Microgravity
- ClinicalTrials.gov ID
- NCT04028752
- Acronym / sponsor ID
- IRB201902002
- Conditions
- Cardiovascular Diseases
- Keywords
- macrophage, microgravity, blood, cardiovascular disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Grant ended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Space Institute
- Study start
- Jun 2021 (estimated)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
While some knowledge has been gained with regards to macrophage alterations during space travel, most of this work has been limited to macrophage cell lines and has not considered how the effects of microgravity alter macrophages' ability to stimulate tissue repair and regeneration. Specifically, how the macrophage secretion profile and/or interaction with endothelial cells is altered during microgravity culture. Given the extensive data showing the consequence of simulated microgravity to alter endothelial cells, and the mounting evidence that simulated microgravity affects macrophage cells, the investigators hypothesize that microgravity alters the functional response of macrophages in close association with endothelial cells. To test this hypothesis, the study team has established 2 specific aims:
Specific Aim 1: Assess the effect of simulated microgravity on endothelial and macrophage pro-healing states.
Specific Aim 2: Assess the effect of simulated microgravity on the pro-healing states of 3-dimensional co-cultured macrophages and endothelial cells.
Completion of the above described aims will lay a strong foundation of knowledge about the impact of simulated microgravity in important cell-cell interactions involved in tissue regeneration and healing
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males and females | – | Biological: Blood collected specifically for this studyThe investigators are interested in sampling a wide variety of individuals from varying ethnic groups, sex, and age range. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General population between 21-50 years old.
Key inclusion criteria (2 listed)
- Self-reported healthy individuals
- Willingness to have 50mls of whole blood collected
Key exclusion criteria (1 listed)
- Unwillingness to have blood used in microgravity study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collected specifically for this studyThe 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. | Biological | Males and females |
Primary outcome
Isolate macrophages
Time frame: within 4 hours of blood collection
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No. Data obtained will be disseminated through publications and conference presentations. No subject data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josephine Allen, Ph.D. principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolate macrophages (time frame: within 4 hours of blood collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 31 Oct 2026.