Control of Leukocyte Function

Inflammation, Brain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027232
• Other study ID #: 2007P000215
• Status: Completed
• First received: January 13, 2017
• Last updated: April 26, 2018
• Start date: January 2007
• Est. completion date: December 15, 2017

Study information

• Verified date: April 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The protocol is to draw peripheral blood from healthy volunteers for in vitro studies. The aims of these in vitro studies are to determine the cellular and intracellular mechanisms by which hypertonic saline and ATP release regulate neutrophil and lymphocyte functions.

Description:

The proper regulation of leukocyte function is critical for immune defense and to prevent autoimmune diseases. Many aspects of immune cell regulation are unknown. A better understanding could lead to novel therapeutic approaches to improve immune function in patients suffering from various diseases.

The investigators have found that hypertonic conditions regulate leukocyte functions through feedback mechanisms involving ATP release and purinergic receptors. The purpose of the proposed protocol is to obtain access to peripheral blood from healthy volunteers to study these complex regulatory mechanisms in more detail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• any healthy volunteer

Exclusion Criteria:

• pregnancy

• needing/using drugs

• inflammatory or infectious complications

Related Conditions & MeSH terms

• Encephalitis
• Inflammation
• Inflammation, Brain

Intervention

Other:
• No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies
No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.

Locations

Country	Name	City	State
United States	BIDMC	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune cells will be studied in vitro to learn about basic mechanisms of immune cell signaling.	The purpose of this study is to obtain blood from healthy subjects (volunteers) for in vitro studies to explore how immune cells function. Cells will be isolated and subjected to various tests including stimuli that simulate immune cell activation in health and disease. Subjects will not be subjected to any treatments. Only some of the cells (leukocytes) in the blood will be studied. For example, activation events such as cytokine production, the ability of leukocytes (=immune cells) to detect and respond to bacterial products will be assessed. No identifiable information about study subjects will be kept.	Blood is collected as needed; time frame: indefinitely. Blood used between 1-7 days after blood draws.