RESOMACRO: Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05106075

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Procedure: blood sample or joint fluid or gingival exudate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

patients are anonymized

Primary Purpose:

Basic Science

Official Title:

Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

Actual Study Start Date :

Jul 7, 2021

Anticipated Primary Completion Date :

Jan 7, 2024

Anticipated Study Completion Date :

Jan 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: biologic sample collection Blood samples or gingival exsudat collection	Procedure: blood sample or joint fluid or gingival exudate blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips

Arm

Intervention/Treatment

Experimental: biologic sample collection

Blood samples or gingival exsudat collection

Procedure: blood sample or joint fluid or gingival exudate

blood sample collected by peripheral blood mobilization joint fluid collected by punction gingival exudate collected with paper strips

Outcome Measures

Primary Outcome Measures

Quantification of cytokine concentrations in samples by ELISA [up to 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age Limits (18-80 years)
Information and non-opposition for participating in the study
Patients suffering from periodontitis grade III ou IV
Patients suffering from microcristalline arthritis
patient with health insurance

Exclusion Criteria:

patient under corticotherapy
pregnancy
non-compliant patient
patient with no health insurance
patient in exclusion period from an other study
legal incapacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Besançon	Besançon		France	25000
2	Dentist'S Office	Montbéliard		France	25200

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05106075

Other Study ID Numbers:

2020/562

First Posted:

Nov 3, 2021

Last Update Posted:

Nov 3, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

macrophage

inflammation

inflammation resolution

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Nov 3, 2021