Rheumatoid ArthritisNCT03454932
Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From Blood of Patients With Inflammatory Rheumatic Diseases
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Bone Therapeutics S.A.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis
- What is being tested?
- Blood sampling
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 4 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read more
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
- Being tested
- Blood sampling
- Keywords
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis, Rheumatic diseases, Inflammation, Autoimmune diseases, Osteoimmunology
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylarthritis, Rheumatic Diseases, Inflammation, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Patients with Rheumatoid Arthritis Receives: Other: Blood sampling | |
| Psoriatic Arthritis | Patients with Psoriatic Arthritis Receives: Other: Blood sampling | |
| Spondylarthritis | Patients with Spondylarthritis Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 7 days
Secondary outcomes (5)
Record of past and current relevant medical history through questionnaire
Measured: time of first visit
Record of concomitant medications through questionnaire
Measured: time of first visit
Record of disease activity assessment (DAS28 and/or CASPAR and/or ASDAS and/or NY)
Measured: time of first visit
Record of any adverse events (if any)
occurring during and/or after the blood sample collection procedure
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study startMay 2015
- Primary completionApr 2017
- Study completion4 Jun 2017
Why it stopped: limited number of recruited patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Therapeutics S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454932
- Sponsor's protocol ID
- RAPSASPA-HBM
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2015
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03454932
- Acronym / sponsor ID
- RAPSASPA-HBM
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis
- Keywords
- Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis, Rheumatic diseases, Inflammation, Autoimmune diseases, Osteoimmunology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: limited number of recruited patients
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bone Therapeutics S.AIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- 4 Jun 2017 (actual)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: Blood samplingPatients with Rheumatoid Arthritis |
| Psoriatic Arthritis | – | Other: Blood samplingPatients with Psoriatic Arthritis |
| Spondylarthritis | – | Other: Blood samplingPatients with Spondylarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis, Psoriatic Arthritis and Spondylarthritis Subjects
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling | Other | Psoriatic Arthritis, Rheumatoid Arthritis, Spondylarthritis |
Primary outcome
PBMC proliferation, as assessed with PBMC assay
Time frame: 7 days
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).
Secretion of pro-inflammatory cytokines (e.g., IL-1β) and anti- inflammatory cytokines (e.g., IL-10), as assessed with PBMC assay
Time frame: 7 days
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.
5 secondary outcomes
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)
Time frame: time of first visit
Results of the laboratory blood tests for CBC, RF, CRP, HLA-B27
Time frame: 7 days
Results and safety
The study was stopped early (reason given: limited number of recruited patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Bone Therapeutics S.A.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: limited number of recruited patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PBMC proliferation, as assessed with PBMC assay (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.