Microgravity Exposed Endothelial CellsNCT03144492
Microgravity Effects on Co-cultured Vascular Cells Types
An observational study of Microgravity Exposed Endothelial Cells, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microgravity Exposed Endothelial Cells
- What is being tested?
- Blood volume collected specifically for this study
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 1 Feb 2020
- 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: The Study team is interested in sampling a wide variety of health individuals from varying ethnic groups, sex, and age range.
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 stem cell research
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Microgravity Exposed Endothelial Cells
- Being tested
- Blood volume collected specifically for this study
- Keywords
- Cell Culture, Microgravity co-culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood volume collected specifically for this studyBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood volume collected specifically for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 weeks of collecting cells
Secondary outcomes (2)
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.
Measured: through study completion, up to 2 years from the start of the study
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.
Measured: through study completion, up to 2 years from the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start26 May 2017
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microgravity Exposed Endothelial CellsStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Responsible party
- Sponsor
- Investigators
- Josephine Allen, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144492
- Sponsor's protocol ID
- IRB201700297
- Other IDs
- 16-2016GL_FP-0011
- Status last verified
- Feb 2020
- First submitted
- 2 May 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microgravity Effects on Co-cultured Vascular Cells Types
- ClinicalTrials.gov ID
- NCT03144492
- Acronym / sponsor ID
- IRB201700297
- Conditions
- Microgravity Exposed Endothelial Cells
- Keywords
- Cell Culture, Microgravity co-culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA)
- Study start
- 26 May 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 May 2017 (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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| self-reported healthy individuals | – | Biological: Blood volume collected specifically for this studySelf-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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The Study team is interested in sampling a wide variety of health individuals from varying ethnic groups, sex, and age range.
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 stem cell research
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 volume collected specifically for this studyThe 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. | Biological | self-reported healthy individuals |
Primary outcome
Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells
Time frame: 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.
2 secondary outcomes
Gene and Protein expression of normal vs microgravity cultured stem cells
Time frame: through study completion, up to 2 years from the start of the study
Anti-thrombogenic function of normal vs microgravity cultured stem cells
Time frame: through study completion, up to 2 years from the start of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microgravity Exposed Endothelial Cells, run by University of Florida at 1 site in United States.
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: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differentiation (Colony Forming) Kinetics of normal vs microgravity cultured stem cells (time frame: Within 4 weeks of collecting cells). 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 20 Feb 2020.