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.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 30 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Bone Therapeutics S.A is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
The record gives a start of May 2015, a primary completion of Apr 2017 and a completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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