Increased Inflammation-resolving Activity by Omega-3 Monoglycerides in Peripheral Blood Mononuclear Cells (PBMC).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MAG-SPM treatment on isolated PBMC cells, Isolated PBMC cells without treatment..
- Who it may be relevant to
- Registry conditions: Resolution of Inflammation, Reduction of Cell Proliferation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this biological study is to provide Dr. Samuel Fortin's laboratory with a continuous supply of blood mononuclear cells (PBMCs) so that he can pursue research on the potential beneficial effects of monoglyceride omega-3 fatty acids on the resolution of inflammation.
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.
Interventions
- Other MAG-SPM treatment on isolated PBMC cells
Cells are isolated form the participant's blood donation (4x 10mL k2EDTA tubes per participant) and maintained in culture with LPS, a pro-inflammatory and pro-proliferative agent. Then, PBMC are separated in two, one half treated with MAG-SPM and the other half remains with LPS only. Proliferative activities are measured and compared in both cell dish. - Other Isolated PBMC cells without treatment.
Cells are isolated form the participant's blood donation (4x 10mL k2EDTA tubes per participant) and maintained in culture with LPS, a pro-inflammatory and pro-proliferative agent. Then, PBMC are separated in two, one half treated with MAG-SPM and the other half remains with LPS only. Proliferative activities are measured and compared in both cell dish.
Primary outcome measures
- Number of PBMC cells count [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- SCF Pharma — Rimouski
Identifiers
NCT: NCT05161702 · PBMC