- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05161702
Increased Inflammation-resolving Activity by Omega-3 Monoglycerides in Peripheral Blood Mononuclear Cells (PBMC). (PBMC)
Study Overview
Status
Intervention / Treatment
Detailed Description
The biological activity of omega-3 fatty acids requires selective oxidation by lipoxygenase (LOX) enzymes in the human body to form SPM (Specialized Pro-resolving Mediators). The formulations based on omega-3 monoglyceride (MAG-Omega-3) currently marketed by SCF Pharma have been optimized so as not to interfere with this natural metabolism process in the human body. It has already been shown that the antiproliferative activity of docosapentaenoic acid (or omega-3 ADP) can be increased tenfold when it is pre-metabolized using a LOX enzyme from soybean (C. Morin et al. PLEFA (2013) 203-213). This antiproliferative potential may play a key role in the mechanisms of inflammation resolution.
We now want to develop a new line of high performance products by pre-metabolizing MAG-Omega-3 in the form of SPM monoglycerides (MAG-SPM) using the LOX enzyme from soy. The potential for resolving inflammation by MAG-SPM can be measured by cell proliferation assays. To perform these tests, cells of the PBMC type must be isolated from the blood of donors and maintained in culture in the presence of an inflammatory agent (LPS) which induces their proliferation (C. Morin et al. European Journal of Pharmacology 807 (2017)) 205-211). Next, the reduction in proliferation induced by MAG-SPM is quantified and then compared with that of cells not treated with MAG-SPM. This type of test requires a large amount of fresh cells, and therefore, a source of blood sample supply.
This research project is divided into two parts: 1) A protocol for collecting blood samples; 2) A cell proliferation test protocol to demonstrate the activity of MAG-SPM in the resolution of inflammation. This protocol covers the first part of this research project.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Samuel Fortin, PhD
- Phone Number: 418-750-8590
- Email: sfortin@scfpharma.com
Study Contact Backup
- Name: Anne-Julie Landry, M.Sc
- Email: ajlandry@scfpharma.com
Study Locations
-
-
Quebec
-
Rimouski, Quebec, Canada, G0K 1P0
- Recruiting
- SCF Pharma
-
Contact:
- Samuel Fortin, PhD
- Phone Number: 418-750-8590
- Email: sfortin@scfpharma.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant aged of at least 18 years old.
Exclusion Criteria:
- Participant who use omega-3 supplements and / or anti-inflammatory medication such as, but not limited to - Aspirin, Ibuprofen (Motrin, Advil), Celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Voltaren ) within 7 days of day 1 of the study.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of PBMC cells count
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samuel P Fortin, PhD, SCF Pharma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Resolution of Inflammation
-
Saglik Bilimleri UniversitesiNot yet recruitingPerception of Violence | Conflict Resolution Styles
-
National Hepatology & Tropical Medicine Research...UnknownResolution of Septic Shock With TerlipressinEgypt
-
Policlinico HospitalUnknownResolution of Neuromuscular BlockadeItaly
-
Brigham and Women's HospitalNational Institute of General Medical Sciences (NIGMS)CompletedBlister | Inflammation; Skin | ResolutionUnited States
-
Methodist Health SystemCompletedConflict ResolutionUnited States
-
National Taiwan University HospitalCompletedResolution of Bowel ObstructionTaiwan
-
Center of Implantology, Oral and Maxillofacial...Completed
-
Gazi UniversityCompletedConflict Resolution | Intensive Care Nurses | Web-based TrainingTurkey (Türkiye)
-
National Taiwan University HospitalNot yet recruitingthe Correlation Between the Barium Examination and High Resolution Impedance Manometry
-
Dartmouth-Hitchcock Medical CenterRecruiting
Clinical Trials on MAG-SPM treatment on isolated PBMC cells
-
Hospices Civils de LyonActive, not recruitingB Cell Lymphoma | Acute Kidney Injury (AKI) | Infusion of CD19 CAR T CellFrance
-
San Rocco TherapeuticsActive, not recruitingConfirmed Diagnosis of ß-thalassemia MajorItaly