An observational study in Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis, sponsored by Bone Therapeutics S.A. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Bone Therapeutics S.A · Observational
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.
Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects
Exclusion Criteria:
Patients with Rheumatoid Arthritis
Other: Blood sampling
Patients with Psoriatic Arthritis
Other: Blood sampling
Patients with Spondylarthritis
Other: Blood sampling
PBMC proliferation, as assessed with PBMC assay
Freshly prepared cell therapy product and PBMC will be mixed together in wells. Mixes will be incubated for 7 days in a humidified atmosphere of 5% CO2 in air at 37°C. PBMC proliferation will be assessed using tritiated (³H)-thymidine uptake (β-counter).
Time frame: 7 days
Secretion of pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10), as assessed with PBMC assay
Freshly prepared cell therapy product and PBMC will be mixed together in wells. Mixes will be incubated for 7 days in a humidified atmosphere of 5% CO2 in air at 37°C. Pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10) will be measured in culture supernatant using Luminex method.
Time frame: 7 days
Record of past and current relevant medical history through questionnaire
Time frame: time of first visit
Record of concomitant medications through questionnaire
Time frame: time of first visit
Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)
Time frame: time of first visit
Record of any adverse events (if any)
occurring during and/or after the blood sample collection procedure
Time frame: time of first visit
Results of the laboratory blood tests for CBC, RF, CRP, HLA-B27
Complete Blood Count (CBC), formula and electrolytes; Rheumatoid Factor (RF); C-Reactive Protein (CRP); HLA-B27
Time frame: 7 days
No study locations are listed for this record.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Bone Therapeutics S.A