Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases

Sponsor
Centre Hospitalier Régional d'Orléans
Study ID
NCT06842316
Status
Recruiting
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Conditions

  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
  • Inflammatory Bowel Diseases
  • Inflammatory Disorder of Immune System
  • Lupus Erythematosus, Systemic
  • Sjogren's Syndrome
  • Spondylitis, Ankylosing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1 blood sample, 40 mL (collection during a blood test, part of the standard of care for this disease) — OTHER
    Mononuclear and polynuclear peripheral blood cells from subjects suffering from IMID will be exposed in vitro to different inflammatory inducers with and without the concomitant addition of at least 4 different pCB extracts spectrum complete (full spectrum) including a dominant CBD extract and low in THC (\<0.2%), 1 dominant THC extract, 1 balanced THC/CBD extract and 1 dominant CBG extract. The same analyzes will be carried out in the presence of a recognized anti-inflammatory (for example hydrocortisone or dexamethasone) which will thus be used as a positive control.

Study Details

Cannabis, in addition to its psychotropic properties, could have anti-inflammatory and immunomodulatory effects. Phytocannabinoids (pCBs) are a group of molecules naturally secreted by the cannabis plant. The major pCBs are cannabidiol (CBD) and Δ9-tetrahydrocannabinol Δ9 (THC). Only THC has psychotropic effects, which CBD does not have. Alongside these two main components, there is a wide variety of other molecules, such as other pCBs and terpenes which could increase the effects on immune system through synergistic interactions between these different compounds ("entourage effect").In vivo, pCBs essentially interfere with the endocannabinoid system, acting on many ubiquitous receptors, present on a significant number of different cell types. Numerous published studies show that pCBs have immunomodulatory and anti-inflammatory properties by acting on several of these receptors, whether through modulation of the immune response of different cell types, effects on cytokine networks, reduction of innate and adaptive responses and/or impact on cell survival or death (autophagy, proliferation/ apoptosis). The Immune-Mediated Inflammatory Diseases (IMIDs) affect 5 to 7% of the general population in Western countries, involve different organs (joints, skin, digestive tract) but share the same inflammatory mechanisms resulting from a dysregulation of the immune response. Our research focuses on the identification of the most effective phytochemical profile of pCBs, allowing an optimal effect on chronic inflammatory pathologies of interest among immune-mediated chronic inflammatory diseases (IMIDs). The pCB-IMIDs project is therefore part of an innovative translational project, around new therapeutic applications of medical cannabis (CannAppIMIDs). In our study, we will include 100 patients with one of IMIDs among Rheumatoid Arthritis, spondylarthritis, psoriatic arthritis, Sjogren disease and systemic lupus, at different stage and with different treatments. After patient's consent we will collect for research purposes an additional 40 ml of blood during a routine care blood test. Mononuclear and polynucleated blood cells will be exposed in vitro to different full-spectrum pCB extracts (full spectrum extract) including a CBD dominant and low THC extract (\<0.2%), 1 dominant THC extract, 1 balanced THC/CBD extract and 1 dominant CBG extract. In this cross-sectional study, our objective will be to assess the biological effects of different pCB compositions on inflammatory profiles (concentrations of pro and anti-inflammatory cytokines and chemokines) and modulations of expression profiles (autophagy, apoptosis, and cannabinoid receptor expression profile).

Key Dates

First listed
Feb 24, 2025
Start date
Apr 10, 2025
Status verified
Dec 2025
Primary completion
Apr 9, 2027
Completion
Apr 9, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Rheumatoid polyarthritis
    10 patients without, 10 patients under basic treatment (csDMARDs\*) and 10 patients under biotherapy or targeted therapy
  • Arm: Spondyloarthropathy
    20 patients with or without IBD, including 10 under biotherapy or targeted therapy
  • Arm: Psoriatic arthritis
    10 patients without, 10 patients with basic treatment (csDMARD) and 10 patients under biotherapy or targeted therapy
  • Arm: Systemic lupus erythematosus
    10 patients with connective tissue disease (Systemic lupus erythematosus)
  • Arm: Sjögren's syndrome
    10 patients with connective tissue disease (Sjögren's syndrome)

Primary Outcome Measure

The primary outcome is to evaluate the biological effect of exposure of blood cells from patients suffering from IMID to different varieties of pCB extracts on the inflammatory profile. [ Time Frame: One sample at inclusion for all patients ]

Central Contacts

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