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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03454932
• Other study ID #: RAPSASPA-HBM
• Status: Terminated
• Start date: May 2015
• Est. completion date: June 4, 2017

Study information

• Verified date: June 2020
• Source: Bone Therapeutics S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 4, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Collagen Diseases
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylarthritis

Intervention

Other:
• Blood sampling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bone Therapeutics S.A

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (ß-counter).	7 days
Primary	Secretion of pro-inflammatory cytokines (e.g., IL-1ß) 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-1ß) and anti- inflammatory cytokines (e.g., IL-10) will be measured in culture supernatant using Luminex method.	7 days
Secondary	Record of past and current relevant medical history through questionnaire		time of first visit
Secondary	Record of concomitant medications through questionnaire		time of first visit
Secondary	Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)		time of first visit
Secondary	Record of any adverse events (if any)	occurring during and/or after the blood sample collection procedure	time of first visit
Secondary	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	7 days