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

NCT ID: NCT03454932

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-06-04

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis

Patients with Rheumatoid Arthritis

Blood sampling

Intervention Type: OTHER

Psoriatic Arthritis

Patients with Psoriatic Arthritis

Blood sampling

Intervention Type: OTHER

Spondylarthritis

Patients with Spondylarthritis

Blood sampling

Intervention Type: OTHER

Interventions

Blood sampling

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bone Therapeutics S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

RAPSASPA-HBM

Identifier Type: -

Identifier Source: org_study_id