Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases

NCT03454932 | Terminated

• 1 other identifier: RAPSASPA-HBM
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis; Spondylarthritis

Keywords

Rheumatoid Arthritis; Psoriatic Arthritis; Spondylarthritis; Rheumatic diseases; Inflammation; Autoimmune diseases; Osteoimmunology

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  7 days

Secondary Outcomes (5)

• Record of past and current relevant medical history through questionnaire

  time of first visit

• Record of concomitant medications through questionnaire

  time of first visit

• Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)

  time of first visit

• Record of any adverse events (if any)

  time of first visit

• Results of the laboratory blood tests for CBC, RF, CRP, HLA-B27

  7 days

Study Arms (3)

Rheumatoid Arthritis

Patients with Rheumatoid Arthritis

Other: Blood sampling

Psoriatic Arthritis

Patients with Psoriatic Arthritis

Other: Blood sampling

Spondylarthritis

Patients with Spondylarthritis

Other: Blood sampling

Interventions

Blood sampling OTHER

Psoriatic Arthritis; Rheumatoid Arthritis; Spondylarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bone Therapeutics S.A: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Rheumatic Diseases; Inflammation; Autoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: March 6, 2018
• Study Start: May 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 4, 2017
• Last Updated: June 11, 2020

Record last verified: 2020-06