Clinical trial NCT03454932: Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
Official title: Laboratory Research Study of the Immunosuppressive Effect of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Spondylarthritis
Keywords: Rheumatoid Arthritis
Psoriatic Arthritis
Spondylarthritis
Rheumatic diseases
Inflammation
Autoimmune diseases
Osteoimmunology
Lead sponsor: Bone Therapeutics S.A
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects

Brief summary: Rheumatic diseases regroup a variety of disorders affecting the locomotor system including joints, muscles, connective tissues and soft tissues around the joints and bones. Inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic diseases. Such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases (IRD), include arthritis of various origins such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondylarthritis (SpA). Patients with autoimmune diseases such as RA or SpA are in higher risk of fractures compared to the general population.

Initial pharmacotherapies for IRD remain NSAID treatment for pain relief, and anti-resorptive agents (e.g., TNF-alpha blockers) which aim at reducing bone loss and preventing occurrence of new bone erosions. Yet current treatments may have strong side effects and are not always effective (e.g., 35-40% of the patients treated with TNF-alpha inhibitors will initially or progressively loose response). Therefore there is a need for further treatment modalities in IRD, which would focus on both suppressing inflammation and treating bone disorders.

Current research studies indicate that Bone Therapeutics' allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to osteo-regenerative and immune-privileged properties).

The present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases. In this purpose, in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells (PBMCs) of subjects diagnosed with RA, PsA and SpA.


Eligibility criteria: Inclusion Criteria:

* Subjects of 18 years of age or older
* Subjects must belong to one of this group: Rheumatoid Arthritis (RA) Subjects OR Psoriatic Arthritis (PsA) Subjects OR Spondylarthritis (SpA) Subjects

Exclusion Criteria:

* Subjects diagnosed with other autoimmune/inflammatory diseases other than Crohn's disease, psoriasis, uveitis, Sjögren's syndrome and auto-immune thyroiditis
* Subjects with an active cancer and currently receiving a cancer treatment
* Women with known pregnancy
* Breastfeeding women
* Subjects with a known history of HIV and/or Hepatitis B and/or Hepatitis C infection and/or positive for HBs antigens

Primary outcomes:
measure: PBMC proliferation, as assessed with PBMC assay
timeFrame: 7 days
measure: Secretion of pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10), as assessed with PBMC assay
timeFrame: 7 days
Secondary outcomes:
measure: Record of past and current relevant medical history through questionnaire
timeFrame: time of first visit
measure: Record of concomitant medications through questionnaire
timeFrame: time of first visit
measure: Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)
timeFrame: time of first visit
measure: Record of any adverse events (if any)
timeFrame: time of first visit
measure: Results of the laboratory blood tests for CBC, RF, CRP, HLA-B27
timeFrame: 7 days
Other outcomes:
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Study officials:
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